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FDA Issues Final Rule Regulating Many Laboratory-Developed Tests as Medical Devices
The National Law Review· 19 hours agoOn April 29, 2024, the US Food and Drug Administration (FDA) issued the long-awaited final rule...
It’s Been a Long Time Coming – FDA’s Final Rule on Regulation of Laboratory Developed Tests (LDTs)...
The National Law Review· 2 days agoToday, on April 29, 2024, following more than a decade of discourse, the U.S. Food and Drug...
A Sea Change Looms as FDA Finalizes Its Controversial Regulation Asserting Jurisdiction Over LDTs |...
JD Supra· 1 day agoOn April 29, 2024, after years of false starts trying to expand oversight of laboratory developed tests (“LDTs”) through administrative and legislative actions, FDA announced ...
FDA Announces Final Regulation Governing Laboratory Developed Tests | JD Supra
JD Supra· 1 day agoThe U.S. Food and Drug Administration (FDA or Agency) announced on April 29, 2024, in a forthcoming and long-awaited final rule that laboratory developed tests (LDTs) will ...
How Envoy Medical is disrupting the hearing loss industry
TheStreet via Yahoo Finance· 6 hours agoTranscript Below: BRENT LUCAS: Envoy Medical is a hearing health company and really what separates...
FDA finalizes rule to increase oversight of lab tests
Boston Herald· 2 days agoThe rule effectively reclassifies tests developed and performed in a lab as medical devices for the...
FDA Proposes Updated Guidance Concerning Cybersecurity of Medical Devices | JD Supra
JD Supra· 3 days agoThe U.S. Food and Drug Administration ("FDA") has proposed updated guidance, intended to assist individuals in meeting the cybersecurity requirements for FDA</ ...
BrioHealth Solutions Secures Nod from FDA to Begin the INNOVATE Trial Featuring the BrioVAD™ System...
WFRV 5 Green Bay· 20 hours agoBrioHealth Solutions, Inc., a medical technology company focused on developing innovative advanced heart failure solutions, today announced it has received FDA< ...
Roivios Secures FDA Breakthrough Device Designation for JuxtaFlow® RAD, Showcases Pioneering Data at...
The West Side Index & Gustine Press-Standard· 6 days agoRoivios, a pioneering clinical-stage medical device company dedicated to transforming kidney health, is thrilled to announce it has been awarded the prestigious ...
New device at UC Davis helps avoid open heart surgery. Here's how it works
CBS News· 11 hours agoA new device is helping people with heart problems avoid open heart surgery and UC Davis is one of...