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Intro to Medical Device Submission Virtual Course: Navigating FDA Pathways - 510(k), IDE, De Novo, and PMA Requirements for Medical Device Approval in the U.S. (Oct 9, 2025)

PMA, and DeNovo FDA submissions process offers key market opportunities for medical devices in the US. Recent 510(k) changes favor innovative, safer technologies, easing entry barriers. AI/ML adds ...
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FDA Takes a Big Step Forward With the Electronic Submission Gateway

The Food and Drug Administration’s science-based mission includes receiving, generating and reviewing a wealth of data and products from the vast array of manufacturers and firms that the agency ...
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Q&A: A doctor's opinion on the FDA AI certification process

Dr. Erik Langhoff, chief medical officer and consultant for the Bronx Regional Health Information Organization, discusses how ...

FDA outlines new review pathway for drugs treating ultra-rare diseases

The agency's two main review offices will work together to flexibly evaluate medicines for serious conditions that affect ...
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Oncocyte Begins FDA Submissions Process for VitaGraft Transplant Assays

IRVINE, Calif., Dec. 06, 2023 (GLOBE NEWSWIRE) -- Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company, today announced it has begun the FDA single-site process for its VitaGraft ...
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FDA's first Pre-Cert workshops give industry and agency a chance to talk

The road to FDA clearance for medical devices may change radically in the next year. Last summer, initial discussion began around implementing a pre-certification program for medical device companies, ...