After weeks of concerns about the accuracy of an Abbott (NYSE:ABT) rapid COVID-19 diagnostic test, the FDA last night issued a warning that the ID NOW test may return false-negative results. Citing “early data,” the agency said it is “sharing early information … about potential inaccurate results in the spirit of transparency.” A preliminary study released […]
FDA
Allergan, Ideal Implant targets of FDA warning letters
The FDA issued warning letters today to two breast implant manufacturers for failure to comply with regulatory requirements. One letter went to Allergan (now part of AbbVie) for failing to comply with requirements — under two separate premarket approval orders — to conduct post-approval studies to assess the long-term safety and risks of two models of […]
Olympic Ophthalmics wins FDA nod for iTEAR100 neurostimulator
Olympic Ophthalmics announced today that it received FDA de novo clearance for its iTEAR100 neurostimulation technology for acute tear production. The Issaquah, Wash.-based company’s prescription iTEAR100 system stimulates a cutaneous nerve to temporarily increase acute tear production in adults. Olympic Ophthalmics’ neurostimulator is a stand-alone, pocket-size device that requires a 30-second-or-less application to the skin […]
Gilead licenses remdesivir production to 5 generic drugmakers
Gilead Sciences’ (NSDQ:GILD) said Tuesday that it has signed licensing agreements with five generic pharmaceutical manufacturers based in India and Pakistan to further expand supply of remdesivir, the experimental drug being used in the U.S. to treat COVID-19. The non-exclusive, voluntary agreements allow the companies — Mylan (NSDQ:MYL), Cipla, Ferozsons Laboratories, Hetero Labs and Jubilant Lifesciences — […]
Philips lands 510(k) to market ultrasound systems for COVID-19
The FDA has granted Royal Philips (NYSE:PHG) 510(k) clearance to market a wide range of its ultrasound systems to help manage COVID-19-related lung and cardiac complications. Handheld and portable ultrasound solutions in particular have become valuable tools for clinicians treating COVID-19 patients due to their imaging capabilities, portability and ease of disinfection, according to Philips. The 510(k) […]
Eko lands EUA for ECG-based algorithm for COVID-19 patients
Eko announced today that the FDA has issued the company an emergency use authorization (EUA) for its novel ECG-based algorithm designed to provide an easily accessible, rapid screening test for low ejection fraction (low EF), a weak heart pump. Awarded an FDA breakthrough device designation in December 2019, the algorithm’s regulatory review has been further […]
CardioFocus wins FDA approval for HeartLight X3 endoscopic ablation system
CardioFocus announced today that it received FDA approval for its next-generation HeartLight X3 endoscopic ablation system. Marlborough, Mass.-based CardioFocus’ system treats drug-refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF). Last year, the company won CE Mark approval in Europe for the device and in February of this year, it announced that it sought out a PMA […]
FDA grants Abbott EUAs for diagnostic, antibody testing platforms
The FDA so far this week has granted Abbott (NYSE:ABT) two emergency use authorizations (EUAs) allowing diagnostic and antibody tests to run on the company’s Alinity systems. The agency today authorized Abbott’s COVID-19 molecular diagnostic test for use on its new Alinity m molecular laboratory instrument. Abbott said it has begun launching the Alinity m system […]
FDA authorizes Quidel antigen test for rapid COVID-19 detection
FDA has issued a first-of-its-kind emergency use authorization for Quidel‘s COVID-19 antigen test, which enables rapid diagnosis of virus infection. San Diego–based Quidel describes the Sofia 2 SARS Antigen FIA as a rapid point-of-care test to be used with the Sofia 2 fluorescent immunoassay analyzer. It can produce results in 15 minutes. Cardinal Health, Fisher […]
Startup CorVent Medical raises $4.5m for single-use ventilator
CorVent Medical today announced the closing of a $4.5 million seed financing round to support the commercialization of a single-use, critical care ventilator. The financing round is led by European life sciences venture capital firm Sofinnova Partners with participation from Redmile Group, Exor Seeds, Genesis Medtech Group, The Deerfield Foundation, The Pagliuca Family Office and […]
NN’s Paragon Medical launches intubation shield
NN Inc. (NSDQ:NNBR) announced that its Paragon Medical division launched an intubation shield for healthcare workers amid the COVID-19 pandemic. The intubation shield provides a barrier between the healthcare professional and the patient during the intubation and extubation processes, reducing exposure to aerosolized airborne contaminants. Paragon collaborated with Solvay Specialty Polymers in Alpharetta, Ga., to produce […]