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Latest From Annovis Bio, Inc.

After High-Risk Recall And Scathing Inspection Report, Is FDA Warning Letter Next For Philips?

Industry experts weigh in on what the US FDA’s enforcement options are following the company’s high-profile recall of millions of breathing devices and unfavorable facility inspection results.

Enforcement FDA

Damning FDA-483: Philips Didn’t Investigate 222,000 Complaints Of Possible Degraded Foam In Breathing Devices

Royal Philips has been reeling from a June recall of millions of breathing machines, and now it’s been slapped by the US FDA with multiple observations after an on-site inspection. One observation says the company didn’t open formal investigations after receiving hundreds of thousands of complaints of particles and other contaminants when the recalled devices were used.

Enforcement Safety

Minute Insight: Philips Continues Building Monitoring Business By Acquiring Cardiologs

Paris-based Cardiologs is developing machine learning software to analyze electrocardiogram waveforms to detect arrhythmias.

Minute Insights M & A

QSR Author Says FDA – Not Industry – Will Need Most Time To Adapt To New Quality System Reg

Predictions made by Kim Trautman, lead author of the US FDA’s Quality System Regulation, and four other top medtech experts regarding the agency’s upcoming harmonized QSR topped our list of most-read Medtech Insight articles in August.

United States Policy
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