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
DENVER, Oct. 18, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces receipt of U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) for use with patients in the hospital intensive...Read more
GUANGZHOU, China, Oct. 15, 2023 (GLOBE NEWSWIRE) -- Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”) is pleased to announce that followed an earlier Breakthrough Device Designation granted by the US Food and Drug Administration (FDA) for its OverC™ Multi-Cancer Detection Blood Test (MCDBT) in January 2023, its OverC™ MCDBT has been granted Breakthrough Device Designation by the China National...Read more
DENVER, Sept. 29, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces receipt of U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) for use with patients in the hospital intensive...Read more
Pivotal Milestone Accelerates Pathway to Specific Indication LATHAM, N.Y. / Aug 15, 2023 / 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 quality of life for patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough...Read more
LEXINGTON, Mass., July 20, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced today the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the Company’s Candida auris (C. auris) direct-from-blood molecular diagnostic test. This marks the third T2 Biosystems’ product to receive FDA...Read more
Immix Biopharma is a clinical-stage biopharmaceutical company pioneering a novel class of CAR-T cell therapies and Tissue-Specific Therapeutics targeting oncology and immuno-dysregulated diseases with >75 patients treated to-date. Our lead cell therapy asset is NXC-201...
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