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Fda Clearance

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Samsung's advanced sleep apnea detection gets FDA and Korean clearance

Samsung has received regulatory clearance from the US FDA and Korea's MFDS for an advanced sleep apnea detection feature on its wearables. The feature uses an AI algorithm to count breathing disturbances per hour during sleep and categorizes results as mild, occasional, or frequent. It will roll out in November to the Galaxy Watch Ultra 2, Watch 9, and Galaxy Ring in South Korea, with older models like the Watch 8 and Watch 7 to follow via software updates.

Quest Diagnostics to offer at-home BD Onclarity HPV test nationwide in 2025

Quest Diagnostics will roll out an at-home HPV self-collection test using BD's Onclarity assay to patients across the U.S. starting next year. The FDA cleared the test for home use in April, allowing women to collect a sample themselves instead of undergoing an in-clinic pelvic exam.

Owlet's baby monitor hits 2.5 million infants, launches Baby Safety Task Force

Owlet, the FDA-cleared wearable baby monitor co-founded by Kurt Workman, Zach Bomsta and Jordan Monroe, has now monitored more than 2.5 million infants, tracking over 21 trillion heartbeats and two billion hours of sleep data. The company, which grew from zero to $20 million in revenue in its first year and went public in 2021, has also launched a Baby Safety Task Force to work with legislators, clinicians and other brands on industry safety standards.

Meta adds FDA-cleared Hearing Enhancement feature to smart glasses

Meta announced at Meta Connect that select Meta Glasses models will get a Hearing Enhancement feature later this year, aimed at users with mild to moderate hearing loss. It's available via Meta One subscription or a one-time $149 fee, with a 30-day free trial, and does not require a prescription. Ray-Ban models are not included at launch.