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Home | About | Blog

25 Attorney Generals Write Open Letter to FDA on Pulse Oximetry Accuracy

Posted on December 3, 2023

They asked the regulatory body to immediately take six actions to ensure the safety and effectiveness of such devices.

Read the full article at: www.mddionline.com

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Fluidx Medical Introduces New Ultra Embolic Platform

Posted on

The device is designed to address gaps in patient need in relation to moderately distal to proximal embolization.

Read the full article at: www.mddionline.com

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Stretchable E-Skin for Robotic Prostheses

Posted on

Engineers at the University of British Columbia have collaborated with the Japanese automotive company Honda to develop an e-skin for robotic prostheses…

Read the full article at: www.medgadget.com

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First patients treated with CMFlex 3D-printed bone graft

Posted on

Several months after earning FDA clearance, a 3D-printed bone graft product is gaining steam, with uses in a handful of surgical procedures.

Read the full article at: www.fiercebiotech.com

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Medtronic nets twin European cardiac arrhythmia approvals, in pulsed field and cryoablation

Posted on

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.

Read the full article at: www.fiercebiotech.com

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Imaging AI hogs the spotlight at RSNA, with debuts from GE, Siemens, Philips

Posted on

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.

Read the full article at: www.fiercebiotech.com

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House Subcommittee Secures Bipartisan Vote on Faster Access to Innovative Medtech

Posted on

The subcommittee voted to require Medicare to cover all medical devices approved under FDA’s Breakthrough Device Designation for four years.

Read the full article at: www.mddionline.com

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Owlet soars to over-the-counter nod for infant pulse oximeter

Posted on

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.

Read the full article at: www.fiercebiotech.com

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FDA takes up Medtronic recall of stolen laryngoscopes sold on Facebook Marketplace

Posted on

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.

Read the full article at: www.fiercebiotech.com

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Masimo earns FDA smartwatch nod amid Apple Watch patent spats

Posted on

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.

Read the full article at: www.fiercebiotech.com

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