Lesion-specific FFRCT predicts individual cardiovascular outcomes and delivers greater-than-modeled cost savings for real-world population in FISH&CHIPS analyses from England’s National Health Service
MOUNTAIN VIEW, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), announced two new analyses from FISH&CHIPS, a real-world, multicenter, retrospective study of more than... Read more
MRD status after surgery stratifies patients beyond established clinical and genomic risk tools
AUSTIN, Texas / Dec 10, 2025 / Business Wire / Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, together with Alliance Foundation Trials, LLC (AFT) and the Austrian Breast and Colorectal Cancer Study Group (ABCSG), today announced initial translational research results from the international randomized Phase III PALLAS study.
Presented today... Read more
ROCHESTER HILLS, Mich. / Dec 10, 2025 / Business Wire / InfuSystem Holdings, Inc. (NYSE American: INFU) (“InfuSystem” or the “Company”), a leading national health care service provider, facilitating outpatient care for durable medical equipment manufacturers and health care providers, announced today that the Centers for Medicare and Medicaid Services (“CMS”) has added two of the electronic infusion pumps currently utilized by the Company within its Pain Management... Read more
FDA clearance expands da Vinci SP indications to include inguinal hernia repair, cholecystectomy, and appendectomy SUNNYVALE, Calif., Dec. 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 and Drug Administration (FDA) has cleared the da Vinci Single Port (SP) surgical system for use in inguinal hernia repair, cholecystectomy, and... Read more
A new subscription service for Owlet users turns baby health and sleep trends into clear, personalized guidance, while core health tracking and notification features remain free. LONDON / Dec 10, 2025 / Business Wire / Owlet, Inc. (“Owlet” or the “Company”) (NYSE: OWLT), the pioneer of smart infant monitoring, today announced the UK and Ireland launch of Owlet360™, a new subscription service designed to give parents a deeper, personalized understanding of their... Read more
Poised for U.S. market launch in Q1 2027 following the achievement of recent milestones and OsStic’s granted patent in 2025 FORT WORTH, TX, Dec. 10, 2025 (GLOBE NEWSWIRE) -- Sanara MedTech Inc. (“Sanara,” the “Company,” “we,” “our” or “us”) (Nasdaq: SMTI), a medical technology company focused on developing and commercializing transformative technologies to improve clinical outcomes and reduce healthcare expenditures in the surgical market, together... Read more
Abstracts presented include 3 studies involving 263 patients, adding to a growing body of evidence across diverse patient populations supporting broader adoption of ProSense® CAESAREA, Israel, Dec. 10, 2025 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced that... Read more
Momentum continues to build for Company as series of clinical milestones are met, design choices cement differentiation from competition, and timeline comes into focus White Bear Lake, Minnesota--(Newsfile Corp. - December 10, 2025) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced the completion of the first set of activations in the final stage of the pivotal... Read more
First in-market activation of Dario's GenAI roadmap lays clinical and technical foundation for a seamless, conversational AI experience across the entire Dario platform
DarioIQ™ reflects years of innovation in data science, engineering and clinical design backed by Dario's proprietary AI models and 13 billion real-world data points, further reinforcing Dario's position as a leader in digital health NEW YORK, Dec. 10, 2025 /PRNewswire/ -- DarioHealth Corp.... Read more
Data include findings generated using the RaDaR 1.0 assay to assess molecular residual disease and recurrence risk in early breast cancer FORT MYERS, Fla. / Dec 10, 2025 / Business Wire / NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of oncology diagnostic solutions that enable precision medicine, today announced that data utilizing its RaDaR® 1.0 assay for the detection of molecular residual disease (MRD) will be presented at the 2025 San Antonio Breast Cancer... Read more
FDA Clearance Granted After Successful Appeal, Overturning Prior Not Substantially Equivalent (NSE) Outcome
HeartBeam’s Credit-Card Sized Device Delivers Clinical-Grade Insights Directly to Patients Anytime, Anywhere
Pivotal Milestone Unlocks Multiple Key Initiatives in Company’s Growth Strategy SANTA CLARA, Calif. / Dec 10, 2025 / Business Wire / HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful... Read more
ETTLINGEN, Germany / Dec 10, 2025 / Business Wire / Bruker Corporation (Nasdaq: BRKR) today announced several significant European orders for high-performance magnetic resonance systems from three leading research institutions in France and Germany:
In the summer, École Normale Supérieure (ENS-PSL) in Paris, France ordered a novel NMR relaxometry system to be used alongside its recently acquired 900 MHz NMR spectrometer. This unique capability will empower the investigation... Read more
SAN DIEGO, CA / ACCESS Newswire / December 9, 2025 / Modular Medical, Inc. (NASDAQ:MODD) ("Modular Medical"), an insulin delivery technology company with the first FDA-cleared patch pump designed specifically to target all adult "almost-pumpers" with its user-friendly and affordable design, today announced that it has commenced an underwritten public offering (the "offering") of shares of its common stock and warrants to purchase shares of its common stock. The shares of... Read more
Picard Medical / SynCardia Systems LLC mark historic milestone as a patient reaches 2,900 days of continuous support with the SynCardia Total Artificial Heart -- the longest timeframe in the world ever recorded TUCSON, Ariz., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Picard Medical, Inc. (NYSE American: PMI) (“Picard” or the “Company”), parent company of SynCardia Systems LLC, maker of the world’s first total artificial heart approved by both the U.S. FDA and Health... Read more
MENLO PARK, Calif., Dec. 09, 2025 (GLOBE NEWSWIRE) -- BillionToOne, Inc. (NASDAQ: BLLN), a next-generation molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, today reported its financial results for the third quarter ended September 30, 2025 and initiated guidance for the remainder of 2025.
Recent Financial Highlights: Total revenue of $83.5 million in the third quarter of 2025, compared to $38.4 million in... Read more
Board of Directors authorizes new $1 billion share repurchase program WAYNE, Pa., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE:TFX), a leading global provider of medical technologies, today announced it has entered into definitive agreements to sell the company’s Acute Care, Interventional Urology and OEM businesses to two buyers, Intersurgical® Ltd with respect to Acute Care and Interventional Urology, and Montagu and Kohlberg with respect to OEM,... Read more
SALT LAKE CITY, Dec. 9, 2025 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx" or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that the Company is delivering a presentation at the Point-of-Care Testing 2025 Exhibition and Conference in Boston, MA.
The presentation, titled "Exploring the Promise of Portable, Cloud-Connected PCR Diagnostics," will unpack... Read more
New data will be presented about Precise® Molecular Residual Disease (MRD) Test and MyRisk® Hereditary Cancer Test SALT LAKE CITY, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, announced it will present new data in eight abstracts at the 2025 San Antonio Breast Cancer Symposium® (SABCS).
The company will share the latest advances in the MyRisk® Hereditary Cancer Test that... Read more
CHICAGO / Dec 09, 2025 / Business Wire / Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, today announced that ten abstracts have been accepted for presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS). The meeting takes place December 9–12 at the Henry B. González Convention Center in San Antonio, Texas.
“This year at SABCS, our research highlights the power of multimodal data to help unravel... Read more
Agreement follows discussions with STAAR stockholders and the closure of STAAR’s “go-shop” period
New terms include an increase in acquisition price and reductions in payments to executives
Alcon urges STAAR stockholders to vote in favor of the transaction in advance of the December 19, 2025, meeting GENEVA / Dec 09, 2025 / Business Wire / Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced that it... Read more
HORSHAM, Pa., Dec. 09, 2025 (GLOBE NEWSWIRE) -- STRATA Skin Sciences, Inc. (NASDAQ: SSKN), a global leader in in-office dermatologic technologies, announces its participation in the 2025 Ibero-Latin American Congress of Dermatology (TeraCILAD) November 19-22, 2025, where it presented its XTRAC® excimer laser and TheraclearX® acne therapy system. STRATA also reported that, by the end of 2025, there will be over 12 new recurring TheraclearX® accounts in Mexico, reflecting... Read more
Findings reinforce Nuwellis’ leadership in precision ultrafiltration for patients with acute kidney injury and fluid overload. MINNEAPOLIS, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, addressing the critical interplay between the heart and kidneys, today announced the presentation of new real-world data from New York City’s Lenox Hill Hospital... Read more
RA'ANANA, Israel, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Inspira™ Technologies OXY B.H.N. Ltd. (NASDAQ: IINN) ("Inspira," “Inspira Technologies,” or the "Company"), a pioneer in innovative life-support and diagnostic technologies, announced today that the Japan Patent Office has granted Patent No. 7777598. This patent covers the Company’s novel Convertible Dual Lumen Cannula device and method of use, securing exclusive rights in one of the world’s most advanced medical... Read more
Leading European Hospital System Begins Offering On-site Liquid Biopsy Testing Based on Proprietary Guardant360® CDx Technology PALO ALTO, Calif. & ROME / Dec 09, 2025 / Business Wire / Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the successful launch of FPG 360, an in-house liquid biopsy testing service at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Policlinico Gemelli) in Rome, Italy. This partnership... Read more
Report includes nearly 12,000 patients who underwent Lucid's EsoGuard® Esophageal DNA Test on samples collected using its EsoCheck® Esophageal Cell Collection Device
Real-world data confirm excellent technical performance, very rapid cell-collection times, and appropriate physician use, consistent with previously published studies NEW YORK, Dec. 9, 2025 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company"), a commercial-stage,... Read more
Real-world Signatera™ analysis and Foresight CLARITY™ results from the HOVON study demonstrate the value of personalized ctDNA testing in therapy response assessment and surveillance AUSTIN, Texas / Dec 09, 2025 / Business Wire / Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today shared the results from two oral presentations that were presented at the American Society of Hematology (ASH) Annual Meeting.
Real-world Signatera... Read more
Novel technology paves the way for use of the company's industry-leading point-of-care electroencephalography (EEG) system to address long unmet need in delirium monitoring SUNNYVALE, Calif., Dec. 09, 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)... Read more
HAYWARD, Calif. / Dec 09, 2025 / Business Wire / Pulse Biosciences, Inc. (Nasdaq: PLSE) (the “Company” or “Pulse Biosciences”), a company leveraging its novel nPulse™ technology using its proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) energy, today announced a research collaboration with The University of Texas MD Anderson Cancer Center to examine the use of the Company’s nPulse™ Vybrance™ Percutaneous Electrode System for treatment... Read more
Expert panel offers data-driven guidance for integrating DecisionDx-Melanoma into clinical decision-making for patients with melanoma FRIENDSWOOD, Texas, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced the publication of an independent expert consensus paper titled “31-Gene Expression Profiling for Cutaneous Melanoma: An Expert Consensus Panel,”... Read more
LONDON & NEW YORK / Dec 09, 2025 / Business Wire / Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that management will host a webinar to discuss the company’s commercial preparations for treatment-resistant depression (TRD) and clinical trial plans for post-traumatic stress disorder (PTSD) from 10:00-11:30 am ET on January 7, 2026.
The discussion will... Read more
VANCOUVER, BC / ACCESS Newswire / December 9, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT) (OTCQB:BNXTF) (FSE:BXT) is advancing the development of a next-generation "Melt in Your Mouth" cladribine formulation, built on the Company's proprietary oral dissolvable film (ODF) drug-delivery system. The technology is designed for rapid, sublingual (under-the-tongue) absorption of medication and aims to improve treatment access and comfort for people living... Read more
Led by insiders, including Perimeter's CEO Adrian Mendes
Capital to accelerate the commercialization of the current S-Series and strengthen the balance sheet through the pending FDA decision of Perimeter's upcoming B-Series, expected in the first half of 2026 TORONTO and DALLAS, Dec. 9, 2025 /CNW/ - Perimeter Medical Imaging AI, Inc. (TSX-V: PINK) (OTCQX: PYNKF) ("Perimeter" or the "Company"), a commercial-stage medical technology company, today announced... Read more
MENLO PARK, Calif., Dec. 9, 2025 /PRNewswire/ – BillionToOne, Inc. (NASDAQ: BLLN), a next-generation molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, today announced the appointment of Anthony Pagano to its Board of Directors, effective January 1, 2026. Mr. Pagano will also serve as Chair of the Audit Committee.
Mr. Pagano is currently Chief Financial Officer and Executive Vice President of Genmab, a leading... Read more
Lingo, Abbott's first over-the-counter biowearable, expands to Android devices
Continuous glucose monitoring devices help people maintain healthy glucose levels, which are associated with better metabolic health and lower long-term risk of chronic conditions
New data from Lingo users highlight how protein supplementation is linked to lower glucose in people who use continuous glucose monitors, especially for people with obesity, a group at higher risk for prediabetes,... Read more
HENDERSON, Nev.,, December 8, 2025 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, announces the presentation of two abstracts at the North America Conference on Lung Cancer (NACLC) in Chicago recently. The posters highlighted the use of its Nu.Q® Cancer assays in the management of lung cancer patients.
Prognostic Value of Circulating H3K27Me3-Nucleosomes in Newly Diagnosed Lung Cancer Patients
Professor Lea... Read more
Technology uses real-world sleep data and machine learning to help people with sleep apnea start and stay on therapy SAN DIEGO, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Resmed (NYSE: RMD, ASX: RMD), the leading health technology company focused on sleep, breathing and care delivered in the home, today announced it has received U.S. Food and Drug Administration (FDA) clearance for Personalized Therapy Comfort Settings (PTCS), to be marketed as Smart Comfort.
Smart Comfort... Read more
FORT MYERS, Fla. / Dec 08, 2025 / Business Wire / NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of oncology diagnostic solutions that enable precision medicine, will present new data demonstrating how comprehensive genomic profiling (CGP) can refine diagnosis and guide treatment decisions for patients with myeloid malignancies at the 67th American Society of Hematology (ASH) Annual Meeting, which is being held Dec. 6–9, 2025, in Orlando, Florida.
The poster, “... Read more
VT-1953 treatment over 14 days resulted in highly statistically significant improvements in bad smell or malodor associated with malignant fungating wound (primary endpoint) (P = 0.002).
Patient-reported impact of bad smell or malodor on quality of life (secondary endpoint) improved significantly (P = 0.0256), as did wound pain reduction (P = 0.002)
VT-1953 was well-tolerated, with no new safety concerns observed.
Based on these positive Phase 2 results, the company... Read more
First randomized controlled trial of neuromodulation in drug-resistant idiopathic generalized epilepsy (IGE)
18-month data show a 77% median reduction in generalized tonic-clonic (GTC) seizures, supporting forthcoming PMA supplement submission
Remains on track to submit NAUTILUS PMA Supplement to FDA for IGE indication expansion by year-end 2025 MOUNTAIN VIEW, Calif. / Dec 08, 2025 / Business Wire / NeuroPace, Inc. (Nasdaq: NPCE), a medical device... Read more
MOUNTAIN VIEW, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Iridex Corporation (Nasdaq: IRIX), a worldwide leader providing innovative and versatile laser-based medical systems, delivery devices, and accessories for the treatment of glaucoma and retinal diseases, today announced a newly published study in Translational Vision Science & Technology (TVST) examining the thermal dynamics of transscleral laser treatments for glaucoma.1
Led by Tomas M. Grippo, MD, of the... Read more
CALGARY, AB, Dec. 8, 2025 /CNW/ - Nanalysis Scientific Corp. (the "Company" or "Nanalysis") (TSXV: NSCI, OTCQX: NSCIF, FRA: 1N1) is pleased to announce that it intends to complete a non-brokered private placement (the "Offering") of up to 16,666,667 units of the Company (the "Units") at a price of $0.15 per Unit for aggregate gross proceeds of up to $2,500,000. Net proceeds of the Offering will be used for debt reduction.
Each Unit will consist of one common... Read more
BILLERICA, Mass. / Dec 08, 2025 / Business Wire / Bruker Corporation (Nasdaq: BRKR) today announced that its Board of Directors has added Jack J. Phillips to serve on its board of directors, effective as of January 1st, 2026. Mr. Phillips is a senior healthcare industry executive with over 30 years of leadership experience in the diagnostics industry.
Frank H. Laukien, chairman, president and CEO of Bruker Corporation, stated: “Bruker is delighted to add Jack to our board... Read more
Joint study conducted with Memorial Sloan Kettering Cancer Center demonstrates clear, positive impacts on patient care NEW HAVEN, Conn., Dec. 05, 2025 (GLOBE NEWSWIRE) -- Specialty cancer diagnostics company Precipio, Inc. (NASDAQ: PRPO) will be presenting at ASH the findings of a joint study conducted with scientific collaborators from Memorial Sloan Kettering in New York, evaluating Precipio’s BCR::ABL1 assay.
The data from a comprehensive study includes... Read more
TGA approval enables regional launch of Owlet’s clinically validated, award-winning infant health monitor; Owlet360™ subscription marks first international expansion of the Company’s recurring-revenue platform. SYDNEY / Dec 05, 2025 / Business Wire / Owlet, Inc. (“Owlet” or the “Company”) (NYSE: OWLT), the pioneer of smart infant monitoring, today announces that Dream Sock™ is now available for families across Australia and New Zealand. Dream Sock recently... Read more
Cryogenic flow control enhances the efficacy and precision of cryoablation procedures
Robust IP portfolio becomes increasingly strategic as global interest in IceCure's platform and next-generation cryoablation technologies grows following ProSense®'s recent FDA marketing authorization in low-risk breast cancer CAESAREA, Israel, Dec. 5, 2025 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of mi... Read more
Presentations highlight advancements in cancer recurrence detection with Guardant Reveal and real-time treatment response monitoring with Guardant360 Liquid PALO ALTO, Calif. / Dec 05, 2025 / Business Wire / Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, will present a total of 14 abstracts with its research collaborators from multiple studies demonstrating the value of its tissue-free liquid biopsy tests at the 2025 San Antonio Breast Cancer... Read more
Expands Natera’s lead in solid tumor MRD, acquiring ultrasensitive phased variant technology with LOD95 of 0.3 parts per million (ppm) and detection below 0.1 ppm1
Cutting-edge IP adds to Natera’s portfolio of >500 issued or pending patents
Accelerates Natera’s expansion into lymphoma, where Foresight has developed a strong clinical position AUSTIN, Texas & BOULDER, Colo. / Dec 05, 2025 / Business Wire / Natera, Inc. (NASDAQ: NTRA), a global leader in... Read more
SAN RAMON, Calif., Dec. 04, 2025 (GLOBE NEWSWIRE) -- CooperCompanies (Nasdaq: COO), a leading global medical device company, announced today financial results for its fiscal fourth quarter and full year ended October 31, 2025. Fourth quarter 2025 revenue of $1,065.2 million, up 5%, or up 3% organically. Fiscal year 2025 revenue of $4.1 billion, up 5%, or up 4% organically.
Fourth quarter 2025 GAAP diluted earnings per share (EPS) of $0.43, down 27%. Fiscal 2025... Read more
WESTMINSTER, Colo. / Dec 04, 2025 / Business Wire / TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (“TriSalus” or the “Company”), an oncology company integrating novel delivery technology with standard of care therapies to transform treatment for patients with solid tumors, announced today that it will host a virtual key opinion leader (KOL) event on Monday, December 15, 2025 at 2:00 PM ET featuring Juan C. Camacho, MD (Florida State University), who will join company... Read more
HENDERSON, Nev., Dec. 4, 2025 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, today announces the inclusion of its Nu.Q® NETs H3.1 assay in "DETECSEPS", a real-world evaluation of early detection of sepsis. DETECSEPS Consortium was awarded winner of the "Challenge Prevention" call for proposals launched by the French Health Innovation Agency and operated by the Banque Publique d'Investissement, as part of the... Read more
