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Latest From Royal Philips

Philips Trilogy Evo Ventilators, Repair Kits Recalled Because Supplier Used Nonconforming Foam

Specific Trilogy Evo ventilators and their repair kits have been recalled because a Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) foam, a nonconforming material, in the manufacture of their muffler assembly. The US FDA gave the recall a high-risk designation on 26 January.

Recalls Safety

MTI’s Top 21 Of ’21: Omicron, Remote Reg Assessments, QSR Delays, US Capitol Insurrection Make Headlines

What a doozy of a year 2021 was in the medical device space – capped on one end by a deadly insurrection blasted by medtech heavy-hitters, and on the other end by news that the COVID-19 Omicron variant is wreaking havoc on some diagnostics (and many US FDA on-site inspections). Here are Medtech Insight’s Top 21 US regulation, policy, quality control and compliance stories of 2021, as determined by reader interest.

United States Regulation

Philips Releases Toxins Testing Results For Recalled DreamStation Breathing Device

Royal Philips says a first round of testing on its first generation DreamStation has found that the level of volatile organic compounds (VOCs) put off by the recalled device “is not typically anticipated to result in long-term health consequences for patients.”

Safety Quality

Philips Battles To Provide More Information, But Not At The Cost Of Burnout

As medicine is increasingly reliant on medical imaging, Royal Philips hopes its artificial intelligence-bolstered imaging systems align with the demand for more information while overcoming the fear of radiologist burnout.

Diagnostic Imaging Artificial Intelligence
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