The FDA has authorized the first point-of-care (POC) antibody test for COVID-19. The Assure COVID-19 IgG/IgM rapid test device was first authorized for emergency use by certain labs in July 2020 to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection. Late yesterday, the agency announced that it has reissued that […]
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 […]
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 […]
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 […]
Advisory panel to vote on FDA approval of Neovasc Reducer
Nine years after it won the CE Mark in Europe, the Neovasc (NSDQ:NVCN) Reducer device, designed to treat refractory angina, is close to an FDA decision on premarket approval. The agency’s Circulatory Systems Devices Panel is scheduled to discuss the Reducer at a virtual meeting set for Oct. 27, the FDA announced today. In a […]
Varian wins FDA clearance for cancer therapy software
Varian Medical Systems (NYSE:VAR) announced that it received FDA 510(k) clearance for its Eclipse v16.1 treatment planning software. Palo Alto, Calif.-based Varian’s Eclipse V16.1 software is designed to enhance the visibility of soft tissue and provide more accurate information about tissue density, allowing dosimetrists to plan more precisely as they go about performing proton therapy, according […]
BD has a serious recall of some Alaris System infusion pumps with stuck keys
The FDA announced today that the August recall of a Becton Dickinson (NYSE:BDX) Alaris PC unit is Class I, the most serious kind. Initiated on Aug. 4, 2020, the recall pertains to the BD Alaris PC unit 8015 and five affected keypad replacement kits manufactured between April 7, 2017 and June 15, 2020 and distributed between […]
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