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Philips' (PHG) Gets FDA Recall for Trilogy Ventilator Glitch
Zacks via Yahoo Finance· 1 day agoPhilips' (PHG) software update for Trilogy Evo ventilators is set to mitigate a possible power...
San Diego's Cue Health had the first FDA-approved home COVID-19 test. Now the agency says to throw...
U-T San Diego· 15 hours agoEarly in the pandemic, the FDA gave Cue Health the industry’s first emergency use authorization, a...
FDA Approves Roche’s HPV Self-Collection Solution, Allowing Patients to Gather Their Own Samples in...
Pharmaceutical Executive Magazine· 13 hours agoRoche announced that the FDA has approved its human papillomavirus(HPV) self-collection solution,...
...Keeping Track of Your Data — What You Need to Know about FDA’s Draft Guidance on Data Integrity...
The National Law Review· 9 hours agoGiven data integrity issues that have been uncovered in the past, in April 2024, the U.S. Food and...
FDA Recalls Insulin Pump App After 200+ Injuries
Verywell Health via Yahoo News· 14 hours agoTandem Diabetes Care Fact checked by Nick Blackmer Key Takeaways The FDA is recalling an insulin pump app. The t:connect mobile app may drain the battery...
FDA Concludes that Tara Flour is Not GRAS
The National Law Review· 11 hours agoFood and Drug Administration FDA publishes assessment concluding that tara flour does not meet generally recognized as safe GRAS as unapproved food...
FDA approves HPV self-test kit
United Press International via Yahoo News· 12 hours agoThe U.S. Food and Drug Administration has approved a kit that will allow women to collect their own vaginal sample for HPV screening, a move that could...
After FDA warning, Getinge trims sales of heart devices
Becker’s Hospital Review· 21 hours agoAfter the FDA instructed healthcare facilities to avoid using two Getinge heart devices because of quality and safety concerns, the company stopped promoting the products.
FDA issues recall notice for Philips after another respiratory device fails
Medical Device Network via Yahoo Finance· 17 hours agoThe FDA has issued the notice for the company’s Trilogy EVO Continuous Ventilators, warning that...
Abeona Therapeutics bolsters finances as it seeks FDA approval for a key treatment
Crain's Cleveland Business· 14 hours agoIn the April correspondence—known formally as a Complete Response Letter, or CRL—from the FDA, the regulatory agency said it needed additional information from Abeona on manufacturing ...
