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    AI-based voiceprint screener for COVID-19 nets European approval

    From taste and smell to muscle aches and “COVID toes,” the coronavirus affects the body in a variety of ways—including small changes in a...

    OpSens Obtains CE Marking for the OptoWire III

    OpSens Inc. ("OpSens" or the "Company") (TSX: OPS) (OTCQX: OPSSF), a medical device cardiology-focused company commercializing a second-generation fiber optic pressure guidewire to diagnose and treat coronary...

    Infant monitoring tech brand Owlet announces SPAC merger for Q2 2021

    The company currently sells connected wearables and smart monitors to consumers but said that it will be seeking FDA authorization for new products with...

    Stroke treatment device from Israel’s BrainQ wins FDA ‘breakthrough status’

    Only about 5% of victims in the US currently arrive at the hospital in time to benefit from currently approved treatments. BrainQ's AI-based device...

    FDA greenlights Visby Medical’s single-use, portable PCR test for COVID-19

    Visby Medical received a new emergency authorization from the FDA for its rapid, single-use PCR test designed to detect COVID-19 infections at the point...

    First Case with HipInsight Augmented Reality for Joint Replacement

    Surgical Planning Associates (SPA) today announced a major step forward in how surgery can be performed with the introduction of its HipInsight augmented reality (AR)...

    ShiraTronics, Inc. receives FDA Breakthrough Device Designation for Chronic Migraine Neurostimulation

    ShiraTronics, Inc. a privately held medical device company, announced that it has been granted a Breakthrough Device designation by the Center of Devices and...

    Push-button blood collection device receives CE mark

    Seventh Sense Biosystems, (7SBio), developers of a push-button blood collection device, has received CE mark approval from the European Commission for its TAP II...

    First daytime treatment for obstructive sleep apnea receives De Novo authorization

    The eXciteOSA strengthens tongue muscles through electrical stimulation and comes with a companion app for tracking and sharing progress. The FDA has granted De Novo...

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