FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Home AFib Blood Pressure Monitor De Novo Granted

[ Price : $8.95]

FDA grants a de novo marketing authorization to Omron Healthcare for its new home blood pressure monitors featuring AI-powered atr...

Medical Device Recalls Up, Drugs Down: Sedgwick

[ Price : $8.95]

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

SonoMotion De Novo for Stone Clear Ultrasound

[ Price : $8.95]

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

False or Misleading Xeomin Promotion: FDA

[ Price : $8.95]

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

Respironics Recalls Garbin Ventilators

[ Price : $8.95]

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

Innovative Manufacturing Technologies Comments

[ Price : $8.95]

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

Trump Taps RFK Jr. as HHS Secretary

[ Price : $8.95]

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

Boston Scientific Recalls Cryoablation Catheters

[ Price : $8.95]

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

LivaNova Sleep Apnea Device Meets Endpoints

[ Price : $8.95]

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

[ Price : $8.95]

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