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FDA greenlights over-the-counter hearing aids
The FDA has issued a rule clearing the way for over-the-counter hearing aids.
Pressure mounts on FDA to expand pig-to-human organ transplant research
During a two-day conference in late June, policy advisors to the FDA and medical professionals discussed the future of xenotransplantation and "most attendees agreed that human trials are needed to help answer the most pressing research questions."
FDA says updated COVID-19 Omicron boosters won’t require new clinical trials
The agency will use data from previous trials to assess vaccines targeting the BA.4 and BA.5 variants.
FDA asks COVID-19 vaccine makers to update boosters to target new Omicron variants
The BA.4 and BA.5 strains now account for over half of infections in the US, according to the CDC.
Juul can temporarily keep selling its vaping products in the US
A federal appeals court has granted Juul's request to delay the FDA's ban on its vape pens and pods.
Juul asks appeals court to block the US ban on its vaping products
The FDA this week ordered the company to stop selling its e-cigarettes and pods.
FDA bans sales of Juul vape products in the US
The company did not provide "the data needed to determine relevant health risks," the FDA said.
Juul's e-cigarettes could be banned from sale in the US
The FDA is set to announce the move imminently, according to The Wall Street Journal.
Flavored e-cigarettes are exempt from the FDA's proposed menthol ban
The FDA has proposed a ban on menthol cigarettes that doesn't cover e-cigs, but could shape policy for the technology.
Fitbit will roll out a passive heart rhythm monitoring feature after getting FDA approval
Google asked the agency to review its algorithm last month.
Google seeks FDA approval for Fitbit's passive heart rate monitoring tech
Google says its algorithm accurately spots undiagnosed AFib 98% of the time.
FDA clears the first smartphone app to program insulin pump doses
Tandem Diabetes Care's iOS and Android app connects to the t:slim X2 insulin pump.
Rapid COVID tests will soon be fully covered by insurance in the US
The Biden administration has announced that COVID-19 testing kits must be covered by private insurance.
Razer reneges on its claim the Zephyr mask uses 'N95-grade' filters
Razer has removed any mention of its Zephyr and recently announced Zephyr Pro smart face masks including “N95-grade” filters from its website and other marketing materials.
Owlet's infant monitoring sock is back on sale in the US
After it was pulled from sale in the US last fall over a warning from the Food and Drug Administration (FDA), Owlet’s infant monitoring sock is once again available to purchase.
Merck's COVID-19 antiviral pill is the second authorized by the FDA
The FDA has approved a second COVID-19 antiviral pill, but Merck's offering might not get as much uptake as its Pfizer rival.
Owlet stops selling infant monitoring sock after FDA order
Following a warning letter from the Food and Drug Administration (FDA), Owlet has stopped selling its popular Smart Sock family in the US.
FDA proposes rule for over-the-counter hearing aids
When it's finalized, the measure should make it easier for people to access affordable hearing aids.
Withings' ScanWatch is finally coming to the US after FDA clearance
Withings' ScanWatch has received FDA approval for its ECG, clearing the way for the watches to be sold in the US.
Coalition of 31 states calls on FDA to regulate flavored e-cigarettes
New York and 30 other states and territories have urged the FDA regulate e-cigarette flavors and marketing aimed at kids.