FDA
Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.
FDA Approves LANCELOT Technology for Corcym’s Perceval Plus, Enhancing Performance of Sutureless Aortic Valve Replacement
Lancelot Technology:
CORCYM , the medical device company dedicated to providing patients and cardiac surgeons with the best solutions to fight structural heart disease, announces...
FDA Approves Genentech’s TNKase® in Acute Ischemic Stroke in Adults
TNKase is delivered as a single five-second intravenous (IV) bolus, a faster and simpler administration compared to the standard-of-care, Activase, which is administered as an IV bolus followed by a 60-minute infusion. Genentech will also be introducing a new 25 mg vial configuration in the coming months to support the approval of TNKase for AIS.
Co-Diagnostics Announces Intention to Submit Enhanced Version of COVID-19 Test to FDA for 510(k) Clearance
The decision by Co-Diagnostics to withdraw the submission was based on discussions with the FDA regarding the ability to detect a potential deterioration of one component of the test, related to shelf-life stability. Following dialogue with the FDA and exploring the various courses of action available, Co-Dx has determined that the best long-term solution would be to submit a version of the test that has been enhanced to address the matter raised in the 510(k) review process.
Alphyn Reports: FDA Clears Breakthrough Zabalafin Hydrogel for Atopic Dermatitis Treatment
"Zabalafin Hydrogel is on the cutting edge of an evolution in AD therapeutics to treat directly for the first time all aspects of the disease simultaneously. We believe it will be the compelling therapeutic choice to treat AD, offering excellent patient tolerability for worry free, long-term and continuous use, and comprehensive treatment for itch, inflammation, and managing the bacterial microbiome imbalance on the skin that exacerbates the disease and its flare-ups."
Aidoc Secures Landmark FDA Clearance for 1st Foundation Model-Powered Clinical AI Solution of Its Kind
"This isn't just an upgrade, it's a paradigm shift," said Reut Yalon, PhD, Chief Product Officer, Aidoc. "Our goal is twofold: continuously enhance existing solutions with this new technology while simultaneously pushing AI into new frontiers and expanding coverage across a broader range of conditions. This clearance is just the beginning."
U.S. FDA Grants Orphan Drug Designation to Ariceum Therapeutics’ Proprietary Radiopharmaceutical Cancer Therapy
Manfred Rüdiger, Chief Executive Officer at Ariceum Therapeutics, said: "Receiving ODD for 225Ac-satoreotide is a recognition of its potential as a treatment option for patients with SCLC and an important regulatory milestone for Ariceum. The FDA's ODD will support our objective to accelerate the development of 225Ac-satoreotide through human trials to provide a potentially life-saving therapy to patients with limited alternatives."
Huxley Medical’s SANSA Home Sleep Apnea Test Gets FDA Nod
In a clinical trial involving 340 patients across seven institutions, SANSA obtained its initial FDA clearance in 2024, demonstrating its accuracy in comparison to the gold-standard polysomnography. This innovative test incorporates nine distinct physiological channels, such as oximetry, respiratory effort, sleep/wake staging, and a reference electrocardiogram (ECG), into a single patch worn on the chest. This integration allows for a comprehensive understanding of cardiopulmonary health and provides valuable insights.
RapidAI Secures FDA 510(k) Clearance for Groundbreaking AI 3D Head and Neck CTA Imaging: Lumina 3D™
RapidAI continues to pioneer AI advances by revolutionizing 3D imaging with no-click, AI-powered reconstruction.
Caranx Medical Announces FDA Submission of TAVIPILOT Soft: the World’s first AI Software for Real-time Intra-operative Guidance of Transcatheter Heart Valve Implantation
“This first release of our TAVIPILOT software marks an important step toward AI-augmented procedures. Our software is designed to be user-friendly, ensuring that cardiologists and surgeons can integrate it seamlessly into their usual practice. TAVIPILOT Soft allows clinicians to position a prosthetic valve easily and with high precision, ensuring that more patients could benefit from a high quality of care.” says Caranx Medical co-founder and CTO Pierre Berthet-Rayne.
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