25 Attorney Generals Write Open Letter to FDA on Pulse Oximetry Accuracy
They asked the regulatory body to immediately take six actions to ensure the safety and effectiveness of such devices.
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Continue Reading »Fluidx Medical Introduces New Ultra Embolic Platform
The device is designed to address gaps in patient need in relation to moderately distal to proximal embolization.
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Continue Reading »Stretchable E-Skin for Robotic Prostheses
Engineers at the University of British Columbia have collaborated with the Japanese automotive company Honda to develop an e-skin for robotic prostheses…
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Continue Reading »First patients treated with CMFlex 3D-printed bone graft
Several months after earning FDA clearance, a 3D-printed bone graft product is gaining steam, with uses in a handful of surgical procedures.
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Continue Reading »Medtronic nets twin European cardiac arrhythmia approvals, in pulsed field and cryoablation
Medtronic has secured not one but two new European approvals for its cardiac ablation devices to treat irregular heartbeats, while also delivering its second-quarter earnings results.
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Continue Reading »Imaging AI hogs the spotlight at RSNA, with debuts from GE, Siemens, Philips
Companies such as GE HealthCare, Siemens Healthineers, Philips and Hologic aim to keep the momentum in AI going at the annual radiology and digital imaging meeting.
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Continue Reading »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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