US Regulatory Roundup, September 2021: Product Safety, Pediatric Devices, EUAs Revoked, And More

With news of high-risk medical device recalls and troubles with COVID-19 diagnostics, product safety was of paramount concern to Medtech Insight readers in September. Also topping the most-read list were articles focused on pediatric patients, the revocation of emergency use authorizations for products to treat and diagnose COVID-19, and more.

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With news of high-risk medical device recalls and troubles with COVID-19 diagnostics, product safety was of paramount concern to Medtech Insight readers in September, with three safety-related articles landing on our Top 10 list of most-read stories.

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Oura Gets Competitors Banned From US Market, But Faces Ultrahuman Countersuit

 
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Study Finds Public Companies Behind Most Recalled AI Devices

 
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A Johns Hopkins University study found publicly traded companies are responsible for 90% of recalled AI-powered medical devices. The study attributes this link to lower clinical validation, especially among smaller companies, and advocates for increased clinical trials to enhance device safety.

Four-Year Waits, 60-Page NCDs: Consultant Urges Medicare Overhaul

 
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Medical Device Recalls Down In Q1 For Lowest Quarterly Count In 3 Years. But Will It Last?

 

Despite a surge in product recalls across five key industries in the first quarter of the year, medical device recalls were down, according to Sedgwick’s latest recall index. But the firm noted they’ve since ticked up.

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German Health Researchers Prep for Possible Disruptions to PubMed, ClinicalTrials.gov

 

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