FDA Related News

Medical Device Recalls Up, Drugs Down: Sedgwick

The Sedgwick third quarter 2024 recall index documents an increase in medical device recalls and a decrease in drug recalls.

Medical Devices

SonoMotion De Novo for Stone Clear Ultrasound

FDA grants SonoMotion a de novo marketing authorization for its Stone Clear device for the ultrasound treatment of post-lithotripsy kidney stone fragm...

Marketing

False or Misleading Xeomin Promotion: FDA

FDA cautions Merz over misleading representations about its Xeomin in a promotional piece featuring celebrity spokesman Nate Berkus.

Human Drugs

Respironics Recalls Garbin Ventilators

Philips Respironics recalls (Class 1) its Garbin Evo ventilators due to the potential for aerosol deposit accumulation on the devices internal flow se...

Human Drugs

Innovative Manufacturing Technologies Comments

Two stakeholder trade associations suggest changes to an FDA strategy document on innovative manufacturing technologies.

FDA General

Trump Taps RFK Jr. as HHS Secretary

President-elect Donald Trump picks controversial FDA critic and vaccine skeptic Robert F. Kennedy Jr. as his secretary for Health and Human Services.

Human Drugs

Boston Scientific Recalls Cryoablation Catheters

Boston Scientific recalls (Class 1) its POLARx and POLARx FIT Cryoablation Balloon Catheters because of atrio-esophageal fistula risks.

Medical Devices

LivaNova Sleep Apnea Device Meets Endpoints

LivaNova says its aura6000 obstructive sleep apnea treatment met the safety and efficacy endpoints in the OSPREY trial in adults.

FDA Needs Inspection Staff Recruitment Plan: GAO

GAO healthcare director Mary Denigan-Macauley says FDA needs a plan and a strategy for recruiting and retaining new facility inspectors.

Medical Devices

FDA Clears GEs Head-Only MRI Device

FDA clears a GE HealthCare 510(k) for its Signa Magnus, a 3.0T high-performance, head-only MRI scanner.