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.

In our No. 1 story from last month, we explained how Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits made by Abbott Molecular Inc. may falsely diagnose patients as having the SARS-CoV-2 virus when they don’t

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Health Secretary Defends Spending Cuts During Senate Hearing On HHS Budget

 
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Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.

Tariffs Threaten Medtech Innovation And US Position As World Leader, Whitaker Tells Lawmakers

 

During his testimony before US senators on the impact of tariffs on critical supply chains, AdvaMed’s Scott Whitaker said the Trump tariffs could jeopardize America’s preeminence in medtech. Other industry experts echoed similar concerns.

Califf Warns Progress May Be In Danger Due To ‘Decimated’ FDA Staff

 

In Vivo spoke to the previous commissioner of the US FDA about recent ongoings at the agency, and where he believes policy should be directed for patient and industry benefit.

‘Help Us Deregulate’: RFK Announces RFI For Trimming Government Health Agencies

 

HHS Secretary Robert F. Kennedy, Jr. is asking the public to help cut waste across the government’s health agencies. Kennedy announced a 60-day comment period allowing the public to take part in a broader federal initiative to reduce regulations and increase transparency.

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‘Pathologists Are Hungry For AI-Enabled Digital Pathology’

 

Digital pathology makes it possible to unlock insights previously hidden to the human eye, “reshaping how we diagnose and treat patients,” said Nathan Buchbinder, co-founder and chief strategy officer at Proscia. He shared his views on the future of digital pathology and the lessons he has learned from working with pathologists.

First At-Home Cervical Cancer Screening Tool Gets FDA Clearance

 
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The US FDA has approved the Teal Wand, the first at-home cervical cancer screening device. Capable of detecting preclinical cancer with 96% accuracy, it will launch in California in June and expand nationwide soon after.

Beyond The Bladder: Incontinence Impacts Mental Health

 

In recognition of Mental Health Awareness month, Sarah Jenkins, executive director at the National Association for Continence, discussed the mental health issues that often come with incontinence.