Viveve Medical (NSDQ:VIVE) announced that the U.S. Patent & Trademark Office issued a patent for its stress urinary incontinence technology. USPTO issued U.S. Patent No. 10,779,874, allowing Viveve to expand its intellectual property portfolio ahead of its U.S. pivotal Pursuit clinical trial evaluating its treatment of SUI in women, according to a news release. Englewood, Colo.-based […]
Pentax launches high-def bronchoscopes in U.S.
Pentax Medical announced today that it launched its EB-J10 Series bronchoscopes in the U.S. after receiving FDA 510(k) clearance. The Hoya (TYO:7741) subsidiary’s EB-J10 Series bronchoscopes are designed to provide high-definition visualization of the bronchus and have compatibility with the simultaneously launched Defina video processor for supporting pulmonology practices with advanced imaging. Montvale, N.J.-based Pentax’s EB-J10 […]
Patient safety group: Most KN95 masks inferior
Up to 70% of KN95 masks tested by patient-safety organization ECRI do not meet U.S. standards for effectiveness, the group announced today. The findings indicate increased risks of contracting COVID-19 for care providers and patients at hospitals and other healthcare organizations that imported the masks from China, according to the Plymouth, Pa.-based, not-for-profit group. Get the […]
NanoVibronix device gains FDA nod for import to U.S.
NanoVibronix (NSDQ:NAOV) announced today that it received FDA enforcement discretion for the U.S. distribution of the UroShield device. According to a news release, the FDA exercised its enforcement discretion, giving Elmsford, N.Y.-based NanoVibronix’s UroShield an intended use code (IUC), clearing the way for the import of the system to the U.S. amid the COVID-19 pandemic. UroShield […]
Medtronic gains breakthrough nod for VAD driveline
Medtronic (NYSE:MDT) announced today that it received FDA breakthrough device designation for its TYRX absorbable antibacterial driveline wrap. Fridley, Minn.-based Medtronic’s TYRX system is designed to securely hold a percutaneous driveline for patients receiving a ventricular assist device (VAD), according to a news release. Drivelines connect the implanted heart pump to an external controller powered by […]
FDA updates adverse-event database
In a long-promised move, the FDA today announced that it has added several updates to its database of injuries and deaths reportedly related to medical devices. The agency said it now includes new adverse-event summaries, the number of events and exemption number fields in its eMDR, eSubmitter and Manufacturer and User Facility Device Experience Database […]
Abbott gains CE Mark for next-gen MitraClip
Abbott (NYSE:ABT) announced today that it received CE Mark approval in Europe for its fourth-generation MitraClip system. MitraClip G4, the latest installment of the Abbot Park, Ill.-based company’s transcatheter mitral valve repair (TMVR) system, is now approved for use in countries recognizing the CE Mark as a non-surgical option for treating mitral regurgitation (MR) or a […]
Smith + Nephew warns on suture-based repair systems
Smith + Nephew (NYSE:SNN) issued an urgent field safety notice to warn of issues with multiple suture-based repair systems. The safety notice said that the company identified a manufacturing issue in the product packaging process that could result in an improper or incomplete seal of the pouch surrounding the sterile product. If that happens, it could […]
410 Medical wins expanded clearance for LifeFlow device
410 Medical announced that it received FDA 510(k) clearance for its LifeFlow device in the rapid delivery of blood and blood components. Durham, N.C.-based 410 Medical’s LifeFlow device is a rapid infuser designed to deliver one liter of crystalloid fluid through a 20-gauge IV catheter in five minutes for front-line treatment of patients needing urgent […]
Titan Medical gains 2 robotic surgery patents
Titan Medical (TSX:TMD;OTC:TITFX) announced today that it received two U.S. patents for its robotic surgical systems. Toronto-based Titan Medical’s two latest patents bring its global intellectual property portfolio to 58 issued patents and 84 patent applications, according to a news release. Additionally, the company has received notices of allowance in 17 other patent applications and anticipates […]
BD has another Class I infusion device recall
The FDA issued another Class I recall designation for the BD Alaris from Becton Dickinson (NYSE:BDX), this time for potentially incorrect displays. Recalled products include the BD Alaris syringe module (model 8110) and BD Alaris PCA module (model 8120), and the BD Alaris syringe/PCA sizer sensor replacement kit (P/N 122786). Affected products related to the infusion […]
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