Becomes the first and only FDA-cleared seizure detection algorithm for pre-term neonates through adults enabling rapid bedside detection, diagnosis, and treatment of non-convulsive seizures SUNNYVALE, Calif., Nov. 24, 2025 (GLOBE NEWSWIRE) -- CeriBell, Inc. (Nasdaq: CBLL) (“Ceribell”), a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions, today announced...Read more
EDAP Receives FDA 510(k) Clearance for Latest Evolution of Focal One Robotic HIFU AUSTIN, Texas, November 20, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for new ultrasound imaging and workflow enhancements to the Focal One High Intensity Focused Ultrasound (HIFU) system, further strengthening...Read more
Dexcom Smart Basal is designed to make basal insulin initiation and management simpler and more personalized for users and their healthcare providers.* Dexcom Smart Basal is FDA cleared and now the first and only CGM-integrated basal insulin dosing optimizer for adults aged 18 and older with Type 2 diabetes who are using long-acting insulin.1 SAN DIEGO / Nov 19, 2025 / Business Wire / DexCom, Inc. (NASDAQ: DXCM), the global leader in...Read more
ROSA® Knee with OptimiZe™ Offers Personalized Surgical Planning and Drives Confidence in Delivering Accurate and Reproducible Outcomes1 WARSAW, Ind., Nov. 14, 2025 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of ROSA® Knee with OptimiZe™, an enhanced version of its ROSA® Knee System that...Read more
Deep TMS™ becomes first and only TMS device cleared in treatment of patients aged 15 to 86 suffering from depression BURLINGTON, Mass. and JERUSALEM, Israel, Nov. 13, 2025 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced that the U.S. Food and Drug Administration (FDA) has...Read more
First-of-its-kind, automated system delivers increased sensitivity, specific identification of disease markers and improved laboratory workflow to support fast, confident diagnoses WALTHAM, Mass. / Nov 12, 2025 / Business Wire / Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced 510(k) clearance of the EXENT® Analyser and Immunoglobulin Isotypes (GAM) Assay**, a first-of-its-kind automated...Read more
PRINCETON, N.J., Nov. 11, 2025 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq: IART), a leading global medical technology company, is pleased to announce the FDA 510(k) clearance for use of its CUSA® Clarity Ultrasonic Surgical Aspirator System for cardiac surgeries. The recent clearance for specific cardiac indications encompasses the debridement of unwanted tissue in cardiac surgeries, including valve replacement...Read more
ST. LOUIS, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it received U.S. Food and Drug Administration 510(k) clearance for its latest generation robotic system, GenesisX™. GenesisX is the latest advance in endovascular surgical robotics, building upon the established benefits of Robotic Magnetic...Read more
Venus NOVA is the first product clearance from the Company’s new R&D strategy TORONTO, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Venus Concept Inc. (“Venus Concept” or the “Company”), a global leader in medical aesthetic technology, announced today that it has received a 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) to market the Venus NOVA™, the Company’s next-generation multi-application platform designed to...Read more
Clearance expands menu and enables high-sensitivity troponin I measurement to aid in the diagnosis of myocardial infarction SAN DIEGO, Nov. 3, 2025 /PRNewswire/ -- The U.S. Food and Drug Administration ("FDA") has granted QuidelOrtho Corporation (Nasdaq: QDEL) ("QuidelOrtho"), a global leader of in vitro diagnostics, 510(k) clearance for the VITROS hs Troponin I Reagent Pack (the "VITROS hs Troponin I Assay"). The...Read more
FRANKLIN LAKES, N.J., Nov. 3, 2025 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX) a leading global medical technology company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Conformité Européenne (CE) marking in the European Union for its Enteric Bacterial Panel* (EBP) and Enteric Bacterial Panel plus* (EBP plus) for the BD COR™ System. By leveraging advanced...Read more
Clearance expands Company's competitive advantage of clinically proven, minimally invasive technologies to treat debilitating SI joint conditions from multiple surgical approaches SImmetry+'s New 3D printed titanium implants, robust joint decorticator, and simple bone graft delivery system provides physicians treatment options rooted in established fusion principles Company initiating alpha launch of SImmetry® + with select group of...Read more
Rules out Alzheimer's pathology in early stages to enhance diagnostic pathway efficiency Provides new opportunity to broaden access and improve referral quality Features as part of Roche's growing portfolio designed to further shape Alzheimer's diagnostic pathways INDIANAPOLIS, Oct. 13, 2025 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States Food and Drug Administration (FDA) has cleared...Read more
Initiated Nationwide Commercial Launch of AYON in September The Company is Hosting a Virtual Key Opinion Leader Event to Discuss the Commercial Launch of AYON on October 14, 2025 CLEARWATER, Fla., Oct. 13, 2025 (GLOBE NEWSWIRE) -- Apyx Medical Corporation (NASDAQ: APYX) (“Apyx Medical” or the “Company”), the manufacturer of a proprietary helium plasma and radiofrequency platform technology marketed and sold as Renuvion® and the AYON...Read more
New Panther Fusion Gastrointestinal Bacterial and Expanded Bacterial Assays deliver tailored, actionable diagnostic results to support fast and informed patient care MARLBOROUGH, Mass. / Oct 02, 2025 / Business Wire / Hologic, Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays. The company...Read more
AI-Powered Heartflow Plaque Analysis to be Covered by Cigna Health Plans Nationwide MOUNTAIN VIEW, Calif., Sept. 22, 2025 (GLOBE NEWSWIRE) -- Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Next Gen Heartflow Plaque Analysis algorithm and the platform is now available. The...Read more
CHICAGO / Sep 22, 2025 / Business Wire / Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its RNA-based Tempus xR IVD device. xR IVD will be offered as a life sciences tool to support drug development programs. RNA sequencing captures a large array of biological...Read more
CHICAGO / Sep 11, 2025 / Business Wire / Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its updated Tempus Pixel, an AI-powered cardiac imaging platform. This update allows the generation of T1 and T2 inline maps, further enhancing the device’s capabilities for cardiac MR image...Read more
Accelerated Launch Readiness Plans Position Company for Commercialization during Q4 2025 The Company’s Initial Addressable Market Includes Approximately 2.5 Million Peripheral Endovascular Procedures in the U.S. Annually CEO, President & Chairman to Present Live Webcast at the H.C. Wainwright Annual Investor Conference on September 9, 2025, at 9 AM ET. HINGHAM, Mass., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Microbot Medical...Read more
SOLANA BEACH, CALIFORNIA / ACCESS Newswire / September 4, 2025 / ClearPoint Neuro, Inc. (NASDAQ:CLPT) (the "Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced that the ClearPoint Prism® Neuro Laser Therapy System ("ClearPoint Prism") received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to include 1.5T MRI guidance in addition to the...Read more
GALWAY, Ireland, Sept. 2, 2025 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced two U.S. Food and Drug Administration (FDA) regulatory milestones that broaden the MiniMed™ 780G system portfolio: clearance of the SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC), enabling integration with the Instinct sensor, made by Abbott, for type 1 diabetes, and approval...Read more
U.S. market entry set to begin for QIAstat-Dx Rise – a version of QIAstat-Dx for syndromic testing that combines unparalleled throughput with the easiest workflow QIAstat-Dx Rise launch can process up to 160 samples per day, initial launch includes Respiratory Panel Plus and Respiratory Panel Mini and additional panels in development Expansion of QIAstat-Dx instrument portfolio in the U.S. builds on the availability of both system...Read more
MINNEAPOLIS, Aug. 21, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on fluid management, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for a new size of its Dual Lumen Extended Length Catheter (dELC). Advancing a broader fluid management platform: This clearance supports Nuwellis’ multi-year plan to build a comprehensive fluid management...Read more
Now Available for Both Cerebral and Somatic Applications and for All Patient Populations, O3’s Delta Hemoglobin Parameters Offer Clinicians Additional Insight Into Changes in Tissue Oxygen Saturation IRVINE, Calif. / Aug 19, 2025 / Business Wire / Masimo (NASDAQ: MASI) today announced the FDA 510(k) clearance of expanded indications for the delta hemoglobin parameters provided with O3® Regional Oximetry. The parameters (ΔcHb, ΔHHb, and...Read more
FDA Clearance Further Validates Technology Platform and Offers Alternatives to Pharmaceutical and Invasive Surgical Treatments EDEN PRAIRIE, Minn., Aug. 18, 2025 (GLOBE NEWSWIRE) -- NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) ("NeuroOne" or the "Company"), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, has received U.S. Food and...Read more
TechLive™ is a vendor-agnostic integrated solution enabling remote scanning of MR, CT, PET/CT, and Ultrasound procedures Amidst radiology technologist shortages, remote scanning in a command center configuration enables the workforce to scan at multiple locations simultaneously with a high level of expertise RadNet has connected more than 300 MR, CT, PET/CT, and Ultrasound systems with TechLive™, delivering operational efficiency and...Read more
DURHAM, N.C., July 30, 2025 (GLOBE NEWSWIRE) -- Bioventus Inc. (Nasdaq: BVS), a global leader in innovations for active healing, announced today a significant milestone with the U.S. Food and Drug Administration (FDA) 510(k) clearances for both TalisMann™ and StimTrial™, expanding the Company’s innovative portfolio of Peripheral Nerve Stimulation (PNS) solutions for chronic pain management. These two clearances mark an important step...Read more
New CLIA-Waived Test Delivers Digital Results to Support Timely Clinical Decision-Making FRANKLIN LAKES, N.J., July 30, 2025 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD Veritor™ System for SARS-CoV-2, a digital test designed to detect COVID-19 antigens in symptomatic...Read more
ST. LOUIS, July 28, 2025 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its groundbreaking MAGiC Sweep™ catheter. MAGiC Sweep is the world’s first robotically navigated high-density electrophysiology (EP) mapping catheter, representing a...Read more
HyHub and HyHub Duo Reduce the Number of Steps Required to Prepare HYQVIA1 First Devices Customized for a Plasma-Derived Therapy in Takeda’s Broad and Differentiated Portfolio Reflect Company’s Commitment to Providing a Patient-Centric Ecosystem of Support Created With Input from Patients and Caregivers to Help Improve In-Home Infusion OSAKA, Japan & CAMBRIDGE, Mass. / Jul 21, 2025 / Business Wire / Takeda (TSE:4502/NYSE:TAK)...Read more
CHICAGO / Jul 16, 2025 / Business Wire / Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Tempus ECG-Low EF (ejection fraction) software, which uses AI to identify certain patients who may have a low left ventricular ejection fraction (LVEF). Tempus ECG-Low...Read more
Streamlining total ankle replacement with data-driven implants and surgical flexibility PORTAGE, Mich. / Jun 25, 2025 / Business Wire / Stryker (NYSE:SYK), a global leader in medical technologies, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Incompass® Total Ankle System, an implant intended for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative...Read more
WINTER SPRINGS, Fla., May 29, 2025 (GLOBE NEWSWIRE) -- Iradimed Corporation (NASDAQ: IRMD), a global leader in innovative medical devices for MRI environments, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its next-generation MRidium® 3870 IV Infusion Pump System. This advanced, MRI-compatible infusion pump extends Iradimed’s unique position as the world’s only supplier of non-magnetic...Read more
The AYON Body Contouring System is the first FDA cleared all-in-one platform for the aesthetic surgical suite Plan to initiate the commercial launch of the AYON Body Contouring System to key opinion leader surgeons in critical geographies during the second half of 2025 CLEARWATER, Fla., May 13, 2025 (GLOBE NEWSWIRE) -- Apyx Medical Corporation (NASDAQ:APYX) (“Apyx Medical”; the “Company”), the manufacturer of a proprietary helium...Read more
WAYNE, Pa., April 30, 2025 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of an expansion to the Indications for Use of the QuikClot Control+™ Hemostatic Device to include all grades of internal and external bleeding. The QuikClot Control+™ Device was previously indicated for temporary control of class III...Read more
First FDA clearance for Nanox.ARC X to produce tomographic images for general use, including musculoskeletal, pulmonary, intra-abdominal and paranasal indications Enhanced imaging system features sleek design with smaller footprint; simplified ‘plug and play’ installation process System design enables software upgrades and new capabilities to be added remotely following future regulatory clearances PETACH TIKVA, Israel,...Read more
SUNNYVALE, Calif., April 15, 2025 (GLOBE NEWSWIRE) -- CeriBell, Inc. (Nasdaq: CBLL) (“Ceribell”), a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its next generation Ceribell Clarity™ algorithm for the detection of electrographic seizures in patients ages 1...Read more
SUNNYVALE, Calif., April 10, 2025 (GLOBE NEWSWIRE) -- Intuitive (Nasdaq: ISRG), a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, today announced that the U.S. Food & Drug Administration (FDA) cleared the company’s fully wristed SP SureForm 45 stapler for use with its da Vinci SP surgical system in thoracic, colorectal, and urologic procedures. Like its multiport...Read more
Dexcom G7 15 Day* is now cleared in the US for people age 18 years and above with diabetes. Now the longest lasting*,†,1 and most accurate1 CGM system, Dexcom G7 15 Day gives users the knowledge to better control diabetes. For people between the ages 2 to 18, Dexcom G7 remains the most accurate2 continuous glucose monitoring system. SAN DIEGO / Apr 10, 2025 / Business Wire / DexCom, Inc. (NASDAQ:DXCM), the global leader in glucose...Read more
New devices address infusion delivery variability and expand the ICU Medical IV Performance Platform. SAN CLEMENTE, Calif., April 7, 2025 /PRNewswire/ -- ICU Medical Inc. (NASDAQ:ICUI), a worldwide leader in the development, manufacture and sale of innovative medical devices, has announced 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) for the Plum Solo™ precision IV pump, a single-channel complement to...Read more
WAYNE, Pa., April 01, 2025 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced FDA 510(k) clearance of the AC3 Range™ Intra-Aortic Balloon Pump (IABP). Leveraging the patented technology of the AC3 Optimus™ IABP, the AC3 Range™ IABP is designed to provide reliable, ongoing IABP support across various patient transport modes, including ambulances and both fixed- and...Read more
CARLSBAD, Calif., March 25, 2025 (GLOBE NEWSWIRE) -- Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG) (OTCQB: ASAPF), a leader in innovative spine and interventional pain management solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Company’s newest product, the AERO™ Facet Fusion System. The AERO MIS Facet Fusion System is a novel, patent-pending device...Read more
TUCSON, Ariz., March 21, 2025 /PRNewswire/ -- Accelerate Diagnostics, Inc. (Nasdaq: AXDX), an innovator in rapid in vitro diagnostics for microbiology, today announced the submission of its Accelerate WAVE™ system and positive blood culture gram-negative test kit to the U.S. Food and Drug Administration (FDA) for 510(k) clearance. The Accelerate WAVE system is designed to provide rapid antimicrobial susceptibility testing (AST) directly...Read more
LEWISVILLE, Texas / Mar 19, 2025 / Business Wire / Orthofix Medical Inc. (NASDAQ:OFIX), a leading global medical technology company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and the European CE Mark for the TrueLok™ Elevate Transverse Bone Transport (TBT) System. TrueLok Elevate provides a limb preservation treatment option for addressing bony or soft tissue deformities and defects such as...Read more
Monogram May Market the Monogram mBôs™ TKA System, Subject to the Requirements of the Federal Food, Drug, and Cosmetic Act (the Act). The Company is Preparing for Commercialization and Evaluating Strategies to Support the Adoption of its Robotic-Assisted Technology AUSTIN, TX / ACCESS Newswire / March 17, 2025 / Monogram Technologies Inc. (NASDAQ:MGRM) ("Monogram" or the "Company"), an AI-driven robotics company focused on improving...Read more
MARLBOROUGH, Mass. and YOKNEAM ILLIT, Israel, March 13, 2025 (GLOBE NEWSWIRE) -- Lifeward Ltd., (Nasdaq: LFWD) (“Lifeward” or the “Company”), a global leader in innovative medical technology to transform the lives of people with physical limitations or disabilities, announced today that the Company has received 510(k) FDA clearance for the newest generation of its personal exoskeleton device, the ReWalk 7. The seventh generation of the...Read more
The new DxC 500i Analyzer Offers Flexibility and Scalability with Broad Chemistry and Immunoassay Assay Menu BREA, Calif., March 10, 2025 /PRNewswire/ -- Beckman Coulter Diagnostics, a clinical diagnostics leader, today announced that the new DxC 500i Clinical Analyzer, an integrated clinical chemistry and immunoassay analyzer, received 510(k) clearance from the U.S. Food and Drug Administration. The DxC 500i combines...Read more
A Revision Knee Implant Alternative for Patients with Metal Sensitivities WARSAW, Ind., March 7, 2025 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of Persona® Revision SoluTion™ Femur, a revision knee implant component offering an alternative for patients with sensitivities to certain...Read more
Toronto, Ontario - TheNewswire - February 27, 2025 - Ventripoint Diagnostics Ltd. ("Ventripoint" or the "Company"), (TSXV:VPT; OTC:VPTDF) is pleased to announce that it has received U.S. Food and Drug Administration (“FDA”) 510(k) clearance for the VMS+™ 4.0 Automated Radiological Image Processing Software/System. This latest advancement of Ventripoint’s proprietary technology, VMS+ 4.0, delivers a number of significant...Read more
MARLBOROUGH, Mass. / Feb 18, 2025 / Business Wire / Hologic, Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s Aptima® SARS-CoV-2 assay, which was first granted Emergency Use Authorization (EUA) status in May 2020. “Our COVID test was instrumental in addressing critical testing needs during the pandemic and offered healthcare providers and laboratories a...Read more
SOLANA BEACH, CALIFORNIA / ACCESS Newswire / January 27, 2025 / ClearPoint Neuro, Inc. (Nasdaq:CLPT) (the "Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced it has received 510(k) clearance for its ClearPoint Navigation Software Version 3.0. "As we prepare for the wave of new patients that will be treated with cell and gene therapies in the years ahead,...Read more
The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay is the first clinically approved in-situ hybridisation (ISH) test with the sensitivity to assess the full spectrum of B-cell lymphoma subtypes.1,2 The test helps differentiate a B-cell cancer from a normal, reactive immune response, offering diagnostic certainty for healthcare providers and their patients. B-cell lymphoma accounts for approximately 85 percent of...Read more
The VENTANA DP 600 slide scanner, part of Roche's Digital Pathology Dx system, is now cleared by the FDA to aid in clinical diagnosis, enabling pathologists to diagnose patients using digital images. This 240-slide scanner produces excellent image quality of stained histology slides from patient tissue samples, while providing ease-of-use and workflow flexibility for the pathology lab. Primary diagnosis in digital pathology helps...Read more
PARSIPPANY, N.J., Jan. 07, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in the delivery of innovative, non-opioid pain therapies to transform the lives of patients, announced today that it has received clearance from the U.S. Food & Drug Administration (FDA) to market a new Smart Tip designed to access the medial branch nerves to manage chronic low back pain. The ioveraº system is an...Read more
CLEARWATER, Fla., Jan. 06, 2025 (GLOBE NEWSWIRE) -- Apyx® Medical Corporation (NASDAQ:APYX) (“Apyx Medical”; the “Company”), the manufacturer of a proprietary helium plasma and radiofrequency technology marketed and sold as Renuvion®, is pleased to announce it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (the “FDA”) for the AYON Body Contouring System. The AYON Body Contouring System was...Read more
GOLETA, Calif. / Dec 30, 2024 / Business Wire / Inogen, Inc. (Nasdaq: INGN), a medical technology company offering innovative respiratory products for use in the homecare setting, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the SIMEOX 200 Airway Clearance Device, expanding the company’s ability to market and meet the various needs of patients with chronic respiratory diseases in the...Read more
New collagen-based dermal matrix designed for tissue generation, complementary to RECELL and PermeaDerm Cohealyx expected to triple AVITA Medical’s addressable market in burns VALENCIA, Calif., Dec. 19, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today announced that the U.S....Read more
Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces it has received 510(k) clearance from the United States Food & Drug Administration for a stemless anatomic total shoulder for the AETOS Shoulder System (AETOS Stemless). AETOS Stemless addresses the growing demand for anatomic total shoulder replacement with a small operating room footprint allowing for an efficient procedure.1 It is...Read more
First cable-free, ambulatory ECG that captures the heart’s electrical signals from three distinct directions for high-fidelity data collection and advanced diagnostics Patients can have the credit card-sized device with them at all times, ready to record an ECG whenever they feel symptoms and reduce delays in care Company to initiate Early Access Program to gain important patient and physician feedback on the use of the system in...Read more
New Anatomically Shaped Asymmetric Stemless Design for Total Shoulder Replacement WARSAW, Ind., Dec. 13, 2024 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the OsseoFit™ Stemless Shoulder System for total shoulder replacement. This innovative implant is designed to match the natural...Read more
LATHAM, N.Y. / Dec 09, 2024 / Business Wire / AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for the NanoKnife System for prostate tissue ablation. The Company received...Read more
Nanox.ARC receives additional FDA clearance to produce tomographic images for general use, including pulmonary, intra-abdominal and paranasal indications, in addition to its previously cleared indication for the musculoskeletal system Nanox.ARC uses high voltage powered digital X-ray tubes for 3D tomosynthesis imaging that could help expand availability of medical imaging Nanox.ARC now deployed at healthcare facilities across seven...Read more
A Total Knee Replacement Alternative for Patients with Metal and/or Bone Cement Sensitivities WARSAW, Ind., Dec. 4, 2024 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of Persona® SoluTion™ Porous Plasma Spray (PPS®) Femur, a total knee implant component offering an alternative for patients...Read more
Company's first 510(k) clearance unlocks a TAM of $40 billion in healthcare B2B opportunities PLEASANTON, Calif., Dec. 2, 2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE), a pioneer in health technology, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the pulse oximeter in its EvieMED Ring. The clearance enables Movano Health to pursue multi-billion dollar business opportunities for health...Read more
SmartMammo™’s AI algorithm now FDA cleared with GE HealthCare’s Senographe Pristina™, expanding access to enhanced cancer detection. The clearance enables RadNet’s DeepHealth and GE HealthCare collaboration to bring together the SmartMammo and Senographe Pristina solutions and transform breast cancer diagnosis. SOMERVILLE, Mass., Nov. 29, 2024 (GLOBE NEWSWIRE) -- DeepHealth, Inc., a wholly-owned subsidiary of RadNet, Inc....Read more
New MRI technology aims to advance neuroimaging and biomarker research CHICAGO / Nov 13, 2024 / Business Wire / GE HealthCare (Nasdaq: GEHC) has received FDA 510(k) clearance for its innovative SIGNA™ MAGNUS,i a 3.0T high-performance, head-only magnetic resonance imaging (MRI) scanner. This system offers new capabilities for both clinical imaging and neuroscience with the potential to aid in the detection of neurological, oncological,...Read more
BOULDER, CO / ACCESSWIRE / November 11, 2024 / Sonoma Pharmaceuticals, Inc. (Nasdaq:SNOA), a global healthcare leader developing and producing patented Microcyn® technology based stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound care, eye, oral and nasal care, dermatological conditions, podiatry, and animal health care, today announced it has received a new 510(k) clearance from the U.S. Food...Read more
Zio AT device, along with the Zio ECG Utilization Software (ZEUS) (K222389), enables the provision of ambulatory Mobile Cardiac Telemetry (MCT) monitoring service for non-critical care patients FDA 510(k)-cleared enhancements will be available in 2025 SAN FRANCISCO, Oct. 30, 2024 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital health care company focused on creating trusted solutions that detect,...Read more
SAN FRANCISCO, Oct. 21, 2024 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital health care company focused on creating trusted solutions that detect, predict, and prevent disease, announced today that the U.S. Food and Drug Administration (FDA) has granted clearance for its 510(k) submission related to prior design changes made to the Zio AT device via letter to file. Zio AT remains commercially...Read more
The Pounce™ Thrombectomy Platform can now be used to remove clot from peripheral arteries as small as 2mm up to as large as 10 mm in diameter, broadening the platform's clinical utility and significantly expanding its addressable market EDEN PRAIRIE, Minn. / Oct 01, 2024 / Business Wire / Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, today announced it has received U.S. Food...Read more
An automated platform designed to fight against Sepsis and Antimicrobial Resistance (AMR) Enables rapid, automated microbial identification on the Bruker MALDI Biotyper® CA System directly from positive blood culture samples TUCSON, Ariz., Sept. 30, 2024 /PRNewswire/ -- Accelerate Diagnostics, Inc. (NASDAQ: AXDX), an innovator of rapid in vitro diagnostics, announced that the U.S. Food and Drug Administration (FDA) has granted...Read more
Vivos is poised to disrupt the very significant pediatric obstructive sleep apnea (OSA) market with new FDA clearance and new strategic marketing and distribution model Vivos’ DNA appliance now approved to reduce snoring and treat moderate to severe OSA in children aged 6 to 17 LITTLETON, Colo., Sept. 18, 2024 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (“Vivos” or the “Company’’) (NASDAQ: VVOS), a leading medical device and...Read more
BOULDER, CO / ACCESSWIRE / September 17, 2024 / Sonoma Pharmaceuticals, Inc. (NASDAQ:SNOA), a global healthcare leader developing and producing patented Microcyn® technology based stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound care, eye, oral and nasal care, dermatological conditions, podiatry, and animal health care, today announced it has received a new 510(k) clearance from the U.S. Food...Read more
ATLANTA, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Femasys, Inc., (Nasdaq: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products, today announced it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for FemChec®, an innovative diagnostic solution for checking the...Read more
While 9 out of 10 people with diabetes are living with T2D, many of the automated insulin delivery solutions currently on the market were designed for people living with T1D. 300-unit insulin reservoir is more suitable for people with T2D who are interested in moving from multiple daily injections (MDI) to pump therapy, based on an average daily dose of 95.9 units of insulin.1 PARSIPPANY, N.J., Sept. 03, 2024 (GLOBE NEWSWIRE) --...Read more
HealthCCSng V2.0 introduces additional ‘zero calcium’ categorization of coronary artery calcium (CAC) and generates a numerical calcium score with corresponding CAC detection category output Marks second FDA 510(k) clearance of HealthCCSng product PETACH TIKVA, Israel, Aug. 21, 2024 (GLOBE NEWSWIRE) -- NANO-X IMAGING LTD (“Nanox” or the “Company,” Nasdaq: NNOX), an innovative medical imaging technology company, today announced that...Read more
SAN JOSE, Calif., Aug. 21, 2024 (GLOBE NEWSWIRE) -- PROCEPT BioRobotics® Corporation (Nasdaq: PRCT) (the “Company”), a surgical robotics company focused on advancing patient care by developing transformative solutions in urology, today announced FDA 510(k) clearance of its next-generation platform, the HYDROS™ Robotic System. Leveraging insights from over 50,000 procedures, HYDROS features FirstAssist AI™ treatment planning, advanced...Read more
SANTA CLARA, Calif., Aug. 20, 2024 (GLOBE NEWSWIRE) -- SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to providing surgical solutions for sacropelvic disorders, announces FDA 510(k) clearance of the iFuse TORQ TNT™ Implant System (TNT). The TNT implant system is designed to meet the specific anatomical and bone mineral density needs of the sacrum and ilium and will serve as the next generation...Read more
Secure Bluetooth® Connectivity Allows Continuous, Accurate Wrist-based Measurements to be Seamlessly Relayed to Caregivers via the Masimo Secure Health Data Cloud IRVINE, Calif. / Aug 12, 2024 / Business Wire / Masimo (NASDAQ: MASI) today announced that the Masimo W1® medical watch has received FDA 510(k) clearance for connectivity, allowing it to be integrated with the Masimo SafetyNet® comprehensive telemonitoring solution. Masimo W1...Read more
WAYNE, Pa., July 31, 2024 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the Ringer™ Perfusion Balloon Catheter (PBC), the only commercially available Percutaneous Transluminal Coronary Angioplasty (PTCA) perfusion balloon.1 The Ringer™ PBC is a rapid-exchange 0.014” compatible catheter with a unique...Read more
Q Guidance System with Spine Guidance 5 Software featuring Copilot is a first-to-market technology, pioneering new planning and surgical capabilities LEESBURG, Va. , July 30, 2024 /PRNewswire/ -- Stryker (NYSE:SYK), a global leader in medical technologies, today announced that its Q Guidance System with Spine Guidance 5 Software featuring Copilot received 510(k) clearance from the U.S. Food and Drug Administration. This...Read more
Toronto, Ontario--(Newsfile Corp. - July 29, 2024) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma" or the "Company"), a developer and investment partner in a wide range of leading-edge, proprietary diagnostic and medical device technologies, is pleased to announce that the Company has received the U.S. Food and Drug Administration's (FDA) approval on its 510K application request to correct the Venowave VW5 device's intended...Read more
PALM BEACH GARDENS, Fla., July 23, 2024 (GLOBE NEWSWIRE) -- ZimVie Inc. (Nasdaq: ZIMV), a global life sciences leader in the dental market, today announced the U.S. launch of its GenTek® Genuine Restorative Components product portfolio. The launch expands ZimVie’s portfolio of end-to-end prosthetic offerings and follows the recent receipt of FDA 510(k) clearance. ZimVie first launched the GenTek portfolio in Europe in 2019 and has seen...Read more
AUDUBON, Pa., July 17, 2024 (GLOBE NEWSWIRE) -- Globus Medical, Inc. (NYSE: GMED), a leading musculoskeletal solutions company, today announced it recently received 510(k) clearance by the U.S. Food and Drug Administration (FDA) for ExcelsiusFlex™ with Total Knee Arthroplasty (TKA) application. This new robotic navigation platform joins the already best-in-class Excelsius™ ecosystem, designed to offer surgeons control, resection accuracy,...Read more
IRVINE, Calif., July 17, 2024 /PRNewswire/ -- InMode Ltd. (NASDAQ: INMD), a leading global provider of innovative medical technologies, is pleased to announce an additional FDA 510(k) clearance for the Morpheus8 technology. Morpheus8 is the first and only fractional radiofrequency (FRF) microneedling technology cleared for contraction of soft tissue. The U.S. Food and Drug Administration (FDA) has cleared the use of the Morpheus8...Read more
Engineered for precision, confidence and efficiency in surgery - and compatible with the CORI◊ Surgical System Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces it has received 510(k) clearance for its new CATALYSTEM Primary Hip System from the United States Food and Drug Administration. The system is designed to address the evolving demands of primary hip surgery including the increased adoption...Read more
LEWISVILLE, Texas / Jul 09, 2024 / Business Wire / Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced the 510(k) clearance and first U.S. implant of the Fitbone™ Transport and Lengthening System. Used to treat large bone defects in the femur and tibia due to trauma, infectious or malignant conditions, the device is the only intramedullary nail designed to transport or lengthen the bone...Read more
CHICAGO / Jun 26, 2024 / Business Wire / Tempus AI, Inc. (NASDAQ: TEM), a leader in artificial intelligence and precision medicine, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Tempus ECG-AF device that uses AI to help identify patients who may be at increased risk of atrial fibrillation/flutter (AF). This is the first FDA clearance for an AF indication in the category known as...Read more
Combined vitreoretinal-cataract system (VCS) and standalone cataract system (CS) are cleared for use in the U.S. New, proprietary technologies designed to deliver transformative surgical innovation Alcon to immediately begin collecting real-world user experience in the U.S. prior to broad commercialization in 2025 First innovations to be introduced from Alcon’s cutting-edge Unity portfolio of surgical equipment Ad Hoc Announcement...Read more
The solution, which includes the VENTANA DP 200 slide scanner, Roche's digital pathology workflow software and a display, is now cleared to aid in clinical diagnosis, enabling pathologists to diagnose patients using digital images. Primary diagnosis for digital pathology enhances healthcare efficiency and helps ensure effective and timely patient care, especially in areas where access to pathologists is limited. This clearance is a...Read more
Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...
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