House Subcommittee Secures Bipartisan Vote on Faster Access to Innovative Medtech
The subcommittee voted to require Medicare to cover all medical devices approved under FDA’s Breakthrough Device Designation for four years.
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Continue Reading »Owlet soars to over-the-counter nod for infant pulse oximeter
Owlet is surely flying high after securing an FDA OK for its Dream Sock system that alerts caregivers if a child’s vital signs leave healthy ranges.
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Continue Reading »FDA takes up Medtronic recall of stolen laryngoscopes sold on Facebook Marketplace
The FDA issued a Class I recall for the 5,700 defective scopes that were stolen after being marked for scrap, then put up for sale on social media.
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Continue Reading »Masimo earns FDA smartwatch nod amid Apple Watch patent spats
About a year after beginning its full market launch, Masimo’s W1 smartwatch can now be used as a medical device in the U.S.
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Continue Reading »FDA OKs Vivos Therapeutics’ oral devices for severe sleep apnea
In much the same way that they’re designed to expand the upper airway, Vivos Therapeutics’ oral appliances have now expanded their FDA indications.
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Continue Reading »Recor Medical claims first FDA approval in renal denervation for stubbornly high blood pressure.
Recor Medical’s renal denervation approach tackles high blood pressure that hasn’t responded to medications or changes in lifestyle.
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Continue Reading »FDA Allege Wavi is Selling Unapproved Neurological Device
While the company states the device doesn’t need IDE or premarket approval because they claim its use is for research purposes only, FDA disagrees.
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Continue Reading »Kidney monitor maker Potrero Medical files for bankruptcy
The former Fierce Medtech Fierce 15 winner announced it has begun to voluntarily restructure its equity through pre-negotiated terms filed in Delaware bankruptcy court.
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Continue Reading »Eko AI spots murmurs at 2x the rate of other stethoscopes: study
Shortly after launching its Sensora platform, Eko Health has published a study detailing the real-world performance of its heart disease detection AI.
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Continue Reading »RefleXion nets $105M to roll out its PET-guided cancer radiotherapy
RefleXion Medical won an FDA clearance earlier this year for its image-guided radiation treatment for lung and bone cancers.
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