JD Supra

FDA Signals Major Shift for QMSR Transition for Medical Device Applications

Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...
JD Supra

Before it hits the shelf: FDA reprocesses the new dietary ingredient notification process

On June 11, 2025, the US Food and Drug Administration (FDA) released educational materials to broaden dietary supplement manufacturers’ and distributors’ awareness and understanding of the FDA’s new ...
https//fedtechmagazine.com

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 ...
Medical Device and Diagnostic Industry (MD+DI)

Why Small Medtech Companies May Struggle with FDA's New Cybersecurity Rules

FDA Section 524B transformed medical device cybersecurity from guidance to law, challenging small medtech firms with ...
MobiHealthNews

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, ...

Celcuity Announces Completion of Submission of Its New Drug Application to the U.S. FDA for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer

This NDA submission is an important milestone, and it brings gedatolisib one step closer to becoming available for patients with HR+/HER2- advanced breast cancer,” said Brian Sullivan, CEO and ...

Akadeum Life Sciences Announces Drug Master File Submission to the US FDA for GMP Microbubble Cell Separation

Akadeum has been successfully customer-audited per US and EU GMP standards, and the products meet endotoxin, sterility, and viral requirements per USP and ICH standards. As expected for raw materials ...

Insight Molecular Diagnostics: GraftAssureDX FDA Submission Warrants Hold Rating

Insight Molecular Diagnostics Inc. is rated Hold due to upcoming catalysts & pending FDA submission for GraftAssureDx. Read ...

HeartBeam seeks FDA nod for ECG synthesis software

SANTA CLARA, Calif. - HeartBeam, Inc. (NASDAQ: BEAT), a $56.5 million market cap pioneer in medical technology currently trading at $2.12 per share, has announced the submission of a 510(k) ...

Nexalin Technology’s Q-Submission for Gen-2 SYNC Accepted by U.S. FDA for the Treatment of Alzheimer’s Disease and Dementia

Nexalin Technology, Inc. (Nasdaq: NXL) (the “Company” or “Nexalin”), the leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain, today announced that the U.S. Food and Drug ...