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
WARSAW, Ind., May 02, 2024 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today announced it has received the “Breakthrough Device” Designation from the Food and Drug Administration (“FDA”) for its new eLLi surgical device, an implant designed to address severe pathology associated with Early Onset Scoliosis (EOS), which can be...Read more
The Elecsys® pTau217 plasma biomarker test is being developed as part of an ongoing partnership between Roche and Eli Lilly and Company Once approved, the test will aid healthcare providers in identifying amyloid pathology, a key feature of Alzheimer’s disease Roche and Lilly believe the test could play an important role in improving access to early and accurate Alzheimer’s diagnosis Basel, 11 April 2024 - Roche (SIX: RO, ROG; OTCQX:...Read more
BILLERICA, Mass. / Mar 04, 2024 / Business Wire / Quanterix Corporation (NASDAQ: QTRX), a leading provider of ultra-sensitive research products and high-definition diagnostics, announced today that its Simoa® phospho-Tau 217 (p-Tau 217) blood test has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) as an aid in diagnostic evaluation of Alzheimer’s Disease (AD). The FDA’s Breakthrough Device...Read more
Focal One HIFU has potential to address large market impacting thousands of women each year LYON, France, March 4, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced today that its Focal One platform has been granted Breakthrough Device designation by the US Food and Drug Administration (FDA) for the treatment of deep infiltrating endometriosis (DIE). In June 2018, the FDA cleared Focal...Read more
Signifies the FDA’s recognition of the Company’s novel Cognitive Behavioral Therapy as a potential treatment for metabolic dysfunction-associated steatohepatitis Opens an accelerated path towards a potential second indication SAN FRANCISCO / Feb 20, 2024 / Business Wire / Better Therapeutics, Inc. (NASDAQ: BTTX), a pioneer in developing prescription digital therapeutics (PDTs) for treating cardiometabolic diseases, today announced...Read more
SAN FRANCISCO / Jan 02, 2024 / Business Wire / Better Therapeutics, Inc. (NASDAQ: BTTX), a pioneer in developing prescription digital therapeutics (PDTs) to treat cardiometabolic diseases, today announced it has submitted a request to the U.S. Food and Drug Administration (FDA) for Breakthrough Device Designation for its novel PDT designed to treat metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic...Read more
Richland WA, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc is pleased to announce that the Food and Drug Administration has granted RadioGel Precision Radionuclide Therapy the designation as a Breakthrough Device pursuant to the FDA’s Breakthrough Devices Program. Dr. Mike Korenko stated “We are pleased with the FDA’s decision to grant Breakthrough Device Designation following our recent data submissions. The FDA...Read more
The ACR-368-tailored OncoSignature assay is being used in Acrivon’s ongoing registrational-intent Phase 2 trial to predict patients most likely to respond to the CHK1/2 inhibitor ACR-368 in three tumor types Drug-tailored, proprietary OncoSignature assays are developed using the Acrivon Predictive Precision Proteomics (AP3) platform which is also used more broadly to uncover resistance mechanisms and rational drug combinations, and for...Read more
ClearPoint Neuro is a global therapy-enabling platform company providing stereotactic navigation and delivery to the brain. Applications of our ClearPoint Neuro Navigation System include electrode lead placement, placement of catheters, and biopsy. The platform has FDA clearance and is...
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