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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

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

Trump Taps RFK Jr. as HHS Secretary

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

Require Studies for Prednisolone Eye Drops: DifGen

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DifGen asks FDA to require long-term refrigerated stability studies for any generic form of its Prednisolone Ophthalmic Solution 1...

Workshop on Patient Experience Data

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Federal Register notice: FDA announces a 12/13 virtual public workshop entitled Patient-Focused Drug Development: Workshop to Disc...

Boston Scientific Recalls Cryoablation Catheters

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