Medtronic (NYSE:MDT) announced today that it received FDA approval for its Onyx Frontier drug-eluting stent (DES). Onyx Frontier, the latest iteration of Medtronic’s Resolute DES family, was designed to leverage the same stent platform as Resolute with an enhanced delivery system for improving deliverability and increasing acute performance, even in the most challenging of cases. […]
FDA
FDA grants STeP designation for Pear Therapeutics’ neurobehavioral digital therapeutic
Pear Therapeutics (Nasdaq:PEAR) announced today that it received STeP designation from the FDA for its Pear-010 product candidate. Boston-based Pear Therapeutics designed its Pear-010 prescription digital therapeutic (PDT) candidate to provide a neurobehavioral intervention (virtual reality-delivered pain reduction) to patients 18 and older with acute postoperative and acute postprocedural pain. Get the full story at our […]
FDA clears antibiotic-embedded hernia mesh for fighting implant infections
Ariste Medical recently won FDA 510(k) clearance for its drug-embedded, polypropylene hernia mesh to fight microbial colonization. The Salt Lake City-based drug-device developer said the patents and proprietary formulations behind the technology could prevent infection, inflammation or clotting associated with implants. Ariste’s synthetic mesh carries two antibiotics — minocycline and rifampin — to prevent contamination […]
GE Healthcare wins FDA premarket approval for software used in anesthesia delivery system
GE Healthcare (NYSE:GE) announced today that the FDA granted premarket approval for its End-tidal (Et) control software in anesthesia delivery. Approval covers the use of the Et control software for general anesthesia delivery on GE Healthcare’s Aisys CS2 anesthesia delivery system. The technology was released in Europe in 2010 and today can be used to […]
FDA approves IDE trial for Fractyl Health’s diabetes reversal tech in type 2 diabetes patients
Fractyl Health announced today that it received FDA approval for an investigational device exemption (IDE) trial of its diabetes reversal platform. Lexington, Massachusetts-based Fractyl Health will evaluate its Revita treatment in patients with type 2 diabetes whose disease is inadequately controlled despite treatment with at least two antidiabetic agents (ADAs) and who are not yet […]
Virpax completes FDA-required preclinical studies for pain-treating topical spray
Virpax Pharmaceuticals (Nasdaq:VRPX) announced today that it completed all FDA-required preclinical studies for its Epoladerm product. Berwyn, Pennsylvania-based Virpax designed its Epoladerm investigational pre-filled topical spray analgesic product for the non-addictive management of chronic pain associated with osteoarthritis (OA) of the knee. Its completed investigational new drug application (IND)-enabling studies included dermal toxicity, sensitization, irritation, […]
How the hospital may become a new market for CGMs
Following a breakthrough nod for Dexcom, CGMs may become a key part of hospital care. As the early stages of the COVID-19 pandemic required action in many forms, continuous glucose monitors became an unexpected part of hospital care. The FDA issued temporary guidance in April 2020 allowing for increased remote monitoring of hospital patients to […]
Viatris, Kindeva win FDA approval for first generic version of Symbicort inhalation aerosol
Viatris (Nasdaq:VTRS) and Kindeva Drug Delivery announced today that the FDA approved its generic version of AstraZeneca’s Symbicort. In March 2021, the FDA granted tentative approval to Breyna (Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol) — the first generic version of Symbicort. Today, the agency granted approval for the abbreviated new drug application (ANDA) for […]
FDA clears Fresenius Kabi wireless Agilia Connect infusion system
Fresenius Kabi announced today that it received FDA 510(k) clearance for its wireless Agilia Connect infusion system. Lake Zurich, Illinois-based Fresenius Kabi’s Agilia Connect infusion system includes the Agilia volumetric pump and the Agilia syringe pump with Vigilant software suite-Vigilant Master Med technology. According to a news release, the two pumps are the first to […]
Dexcom wins FDA breakthrough nod for use of its CGM in hospitals
Dexcom (NSDQ:DXCM) announced that it received FDA breakthrough device designation for the use of its CGM in a hospital setting. The FDA early in the COVID-19 pandemic issued temporary guidance allowing increased remote monitoring of hospital patients in order to limit contact with hospital staff. The guidance included continuous glucose monitors. “What started as a […]
