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FDA Panel Supports Baebies' Seeker Newborn Screen Test

 
• By Sue Darcey

The US agency's Clinical Chemistry and Clinical Toxicology Devices panel showed support Aug. 10 for a de novo submission by Baebies Inc. on its Seeker System for newborn screening for lysomal storage disorders. Panelists said the need for the newborn screen outweighed the uncertainties in setting cutoff points and false-positive/false-negative rates.

Despite observing problems with the way cutoff points and false-positive and negative-rates were established in a pivotal study of Baebies Inc.'s Seeker System, a US FDA advisory panel decided that the medical need for the unique screening system outweighed its weaknesses.

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More from Policy & Regulation

South Korea Adds Digital Health Rules To Already Complicated Regulatory Landscape

 
• By Elizabeth Orr

A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.

Switzerland Investigates Private Sector Assessment of FDA-Approved Medical Devices

 
• By Amanda Maxwell

Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.

New Guidance From Canada’s HTA Agency On Submission Of AI-Driven Evidence

 
• By Neena Brizmohun

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.