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FDA: Cue Health COVID tests may return false positive, negative results, so throw them away
Naples Daily News via Yahoo News· 2 days agoCheck your cabinets. The U.S. Food and Drug Administration (FDA) warned consumers and healthcare...
Roche says FDA approves HPV self-test in US
Colorado Springs Gazette· 1 day agoBERLIN (Reuters) - Swiss drugmaker Roche on Wednesday said the US Food and Drug Administration (FDA) has approved its human papillomavirus (HPV)...
Atraverse receives approval for HOTWIRE Left Heart Access Device
Medical Device Network via Yahoo Finance· 6 hours agoAtraverse Medical has received the US Food and Drug Administration (FDA) clearance for its HOTWIRE...
FDA approves HPV self-collecting test kit, expanding cervical cancer screening access
Scripps News via AOL· 14 hours agoThe FDA has given the green light to a self-collection solution to test for HPV, making it one of...
Lab-Testing Startups Brace for FDA Rule Change
The Wall Street Journal· 3 hours agoThe Food and Drug Administration ruling will increase development costs for lab tests, yet some entrepreneurs and investors welcome the shift.
Citi raises Prime Medicine shares target on FDA Milestone By Investing.com
Investing.com· 5 hours agoThe upgrade follows the recent announcement by Prime that the FDA has cleared an Investigational New...
FDA said it "never" inspected dental lab that made controversial AGGA device
CBS News· 3 days agoThe FDA never inspected Johns Dental Laboratories during more than a decade in which it made the...
Throw out COVID-19 tests made by San Diego company, FDA warns
KSWB articles via Yahoo News· 22 hours agoHealth care company Cue Health received emergency use authorization for two COVID-19 tests from the ...
...Keeping Track of Your Data — What You Need to Know about FDA’s Draft Guidance on Data Integrity...
The National Law Review· 19 hours agoGiven data integrity issues that have been uncovered in the past, in April 2024, the U.S. Food and...
FDA Approves Roche’s HPV Self-Collection Solution, Allowing Patients to Gather Their Own Samples in...
Pharmaceutical Executive Magazine· 23 hours agoRoche announced that the FDA has approved its human papillomavirus(HPV) self-collection solution,...