Stereotaxis receives FDA clearance for robotic surgical device

Stereotaxis Inc. (NYSE: STXS), St. Louis-based developer of robotic technologies to treat arrhythmias and perform ...
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 ...
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Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...
Medical Design & Outsourcing

How listening, learning and leading won FDA de novo classification for Peytant

Peytant Solutions CEO John Schorgl explains how his device startup turned a complex FDA de novo application into a lasting ...

Nanopath Granted FDA Breakthrough Device Designation for Its Molecular Diagnostic Platform for Urinary Tract Infections

Nanopath, a point-of-care diagnostics company enabling high-quality molecular testing in minutes, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device ...
Opinion
PharmabizOpinion

There is urgent need for modern, technology-focused regulatory approach for medical devices: Dr Jagashetty

Nandita Vijayasimha, Bengaluru Wednesday, November 19, 2025, 08:00 Hrs [IST] ...

Arctx Medical Receives FDA Marketing Authorization for its Arctx Cool Catheter™ Set for Body Temperature Regulation, Releases Initial Clinical Results in Acute Pancreatitis

Arctx Medical, Inc. ("Arctx," "the Company"), a clinical-stage medical device company, announced today that it has achieved two additional significant milestones: ...
MedPage Today on MSN

Longtime Oncology Official at FDA Tapped as Top Drug Regulator

A 26-year FDA scientist and administrator, Pazdur has headed the agency's Oncology Center of Excellence since its creation in ...
Stockhead on MSN

Biocurious: Inhalerx hones in on pot for pain and panic in its quest for historic drug approval

Minnow Inhalerx hopes to be first to market with inhaled synthetic medical cannabis therapies for cancer pain and panic ...
Hoodline

Magnetic Tides' kTMP Wins FDA Breakthrough, Eyes Stroke Trials

Berkeley startup Magnetic Tides wins FDA Breakthrough tag for its kTMP brain‑stimulation and is moving into clinical trials.

Arctx Medical Receives FDA Marketing Authorization for its Arctx Cool Catheter(TM) Set for Body Temperature Regulation, Releases Initial Clinical Results in Acute Pancreatitis

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) ...

Mobile Medical Device Apps and the FDA Training Webinar: Classification, Regulatory Requirements and Cybersecurity

The burgeoning field of Software as a Medical Device (SaMD) offers opportunities for innovation in healthcare monitoring and delivery through mobile apps. Regulatory focus by the FDA on "device ...