Breakthrough Device Designation (“BDD”) applies to an estimated U.S. population of over 7.7 million patients with uncontrolled hypertension and increased cardiovascular risk BDD also encompasses pacemaker-indicated patients with uncontrolled hypertension who are the focus of the BACKBEAT global pivotal study Orchestra BioMed is currently enrolling in strategic collaboration with Medtronic, plc (NYSE: MDT) BDD status provides...Read more
DENVER, April 08, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life, announced today that the U.S. Food and Drug Administration (FDA) has granted SeaStar Medical two new Breakthrough Device Designations for its Selective Cytopheretic Device (SCD) therapy. The two new...Read more
The ACR-368-tailored OncoSignature assay is being used to predict patients most likely to respond to ACR-368 in Acrivon’s ongoing, registrational-intent, multicenter Phase 2b trial of ACR-368 in patients with endometrial cancer and other tumor types Clinical data presented at ESMO 2024 demonstrates statistically significant segregation of patient responders in biomarker-positive versus biomarker-negative subgroups based on prospective...Read more
Abbott's investigational AVEIR™ Conduction System Pacing (CSP) leadless pacemaker system is specifically designed to deliver pacing to the left bundle branch area, activating the heart's natural conduction system The device has received U.S. Food and Drug Administration Breakthrough Device Designation, which expedites the review of innovative technologies By creating a new pacing approach for the left bundle branch area of the heart,...Read more
This represents the fourth indication granted a Breakthrough Device Designation for the SCD by FDA DENVER, Nov. 06, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces the receipt of a Breakthrough Device Designation from the U.S. Food and Drug...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
Breakthrough Device Designations are granted by the U.S. FDA to expedite review of promising technologies that address high unmet needs and may improve the lives of people with life-threatening or debilitating conditions REMAIN-1 pivotal study underway to accelerate pathway for weight maintenance indication for Revita®, with anticipated data readouts beginning in Q4 2024 BURLINGTON, Mass., July 30, 2024 (GLOBE NEWSWIRE) -- Fractyl...Read more
On the basis of its positive clinical studies Mainz Biomed has now defined the final configuration including its novel mRNA biomarkers of the Next Generation Test to be used in pivotal registration study ReconAAsense A recent clinical analysis of this new configuration demonstrates sensitivity for colorectal cancer of 97% and 88% for advanced adenomas, with specificity of 93% BERKELEY, Calif. and MAINZ, Germany, July 09, 2024 (GLOBE...Read more
Provides expanded access to FDA and prioritized review of submission MIAMI / Jul 08, 2024 / Business Wire / Pulse Biosciences, Inc. (Nasdaq: PLSE) (the “Company” or “Pulse Biosciences”), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation™ (nsPFA™) technology, today announced that it has received the Breakthrough Device Designation from the U.S. FDA for the Company’s Cardiac Surgery System for the ablation...Read more
Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development...
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