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iHealth’s COVID-19/Flu rapid test secures FDA EUA
Medical Device Network via Yahoo Finance· 2 days agoThe US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for iHealth ...
FDA Finalizes LDT Regulation, with Significant Exceptions: Enforcement of Requirements Will Phase In...
JD Supra· 1 week agoOn April 29, 2024, the Office of the Federal Register placed on display the Food and Drug Administration’s (FDA) final rule on the regulation of laboratory ...
The End of an Era? FDA Finalizes LDT Rule But Grandfathers Many Existing LDTs | JD Supra
JD Supra· 4 days agoOn May 6, 2024, the Food and Drug Administration (FDA) published its final rule for laboratory developed tests (LDTs). The final rule cemented the agency ...
A better COVID treatment for the immunocompromised? Researchers create a non-toxic potential...
Medical Xpress· 2 weeks ago-CoV-2, the virus that causes COVID-19, currently have two options approved by the Food and Drug...
NH firm to market point-of-care COVID-19 antibody test
Hartford Business Journal· 3 days agoPrecipio said Thursday that it signed a sales and distribution agreement with Palo Alto,...
Cue Health to cut 230 employees
MedTech Dive via Yahoo Finance· 1 week agoHowever, Cue’s only FDA authorized tests are the COVID test and an Mpox test that has an EUA, according to Cue’s annual report. A flu test and an RSV...
Liberate Medical starts neuromuscular stimulator trial with $6.5m grant
Medical Device Network via Yahoo Finance· 1 week agoVentFree has breakthrough device designation and emergency use authorization from the US Food and...
Pfizer’s first-quarter results top estimates, while drugmaker boosts full-year profit outlook
Market Watch· 1 week agoAn expected drop in COVID-19-related product sales, including antiviral Paxlovid and vaccine...
Fauci, other top health officials receive Moderna Covid-19 vaccine on camera
AOL· 4 days agoFauci, director of the National Institute of Allergy and Infectious Diseases, received the shot...
Investigations Newsletter: DOJ Secures Plea in $50 Million Medicare Fraud and Kickback Scheme | JD...
JD Supra· 5 days agoOn April 26, the US Department of Justice (DOJ) announced that Manishkumar Patel pleaded guilty to charges related to a $50 million health care fraud and kickback scheme. According to prosecutors ...
