Berkeley startup Magnetic Tides wins FDA Breakthrough tag for its kTMP brain‑stimulation and is moving into clinical trials.
ANSI/AAMI HE75:2025; Human factors engineering - Design of medical devices is the first update to AAMI's premier human factors standard since 2009. The standard is meant to assist users and ...
The Health Sector Coordinating Council’s Cybersecurity Working Group today released a best practices guide for health care organizations and medical device manufacturers that includes an updated ...
The medical device industry faces growing pressure to align U.S. and EU regulations, with the EU’s Medical Device Regulation ...
Peytant Solutions CEO John Schorgl explains how his device startup turned a complex FDA de novo application into a lasting ...
Arctx Medical, Inc. ("Arctx, " "the Company"), a clinical-stage medical device company, announced today that it has achieved two additional significant milestones: Arctx was granted FDA 510(k) ...
Founded in 2024, IKE Tech is building the identity layer for the physical world. With patented technologies spanning blockchain authentication, secure BLE communication, and AI-enhanced access control ...
Minnow Inhalerx hopes to be first to market with inhaled synthetic medical cannabis therapies for cancer pain and panic ...
Stereotaxis Inc. (NYSE: STXS), St. Louis-based developer of robotic technologies to treat arrhythmias and perform ...
FDA Section 524B transformed medical device cybersecurity from guidance to law, challenging small medtech firms with ...
Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...
On Monday, Nov. 3, Haven McCall — a lecturer for the Master of Science (MS) Regulatory Science and MS in Biotechnology ...
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