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Approvals

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Global Device Approvals, Weekly Snapshot: HeartMate 3 Reaches New Destination

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Among the additions, Abbott's HeartMate 3 left ventricular assist device gained "destination therapy" approval from US FDA, meaning its now vetted for use in patients who are not eligible for a heart transplant.

Approvals Innovation Research & Development
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Global Device Approvals, Weekly Snapshot: New Endobronchial Valve, Cell Therapy

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Newly added devices include an endobronchial valve for emphysema approved in the US and an autologous cell therapy for urinary incontinence approved in Japan.

Approvals Innovation

Pear Picks Up Prescription Opioid App Clearance

Novartis subsidiary Sandoz will lead the US launch of Pear Therapeutics' reSET-O prescription-grade mobile app for opioid use disorder in the coming days following US FDA go-ahead.

Digital Health Approvals

Global Device Approvals, Weekly Snapshot: New Shoulder Component, AAA Graft

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Newly added devices include a new LimaCorporate should component, US approval of the Incraft aneurysm stent graft and a first-in-class newborn-screening diagnostic.

Approvals Research & Development

Global Device Approvals, Weekly Snapshot: PMA Drought Continues

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. A electrical stimulator for GI disease is among devices that made the list this week. Also, a drought in original PMAs and panel-track supplements in the US.

Approvals Research & Development

Global Device Approvals, Weekly Snapshot: Medtronic, Edwards Wins In Europe

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. CE marks for a Medtronic stent graft and Edwards Lifesciences' TAVR update anchor this week's list.

Approvals Innovation

Latest Sapien Valve Gets EU Go-Ahead, But Germany Will Have To Wait

Edwards Lifesciences plans a "controlled rollout" of its Sapien 3 Ultra transcatheter heart valve replacement in Europe following the CE mark announced Nov. 16. But a patent dispute with Boston Scientific will prevent Edwards from launching it in Germany.

Approvals Cardiology

Global Device Approvals, Weekly Snapshot: Pelvic Floor Strengthener, Peripheral Stent

A snapshot of medical device approvals captured in Medtech Insight's Approvals Tracker. A muscle stimulation device to treat urinary incontinence passed US FDA's review, while a peripheral artery stent with a new delivery system gained European sign off.

Approvals Gynecology & Urology

Special 510(k) Pilot Includes All Qualifying Submissions, FDA Says

US FDA officials clarified how devices can qualify for an ongoing special 510(k) pilot program during a Nov. 8 online seminar.

Regulation Medical Device

Global Device Approvals, Weekly Snapshot: Parathyroid Detection, Diabetes Tech

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Two devices to help surgeons performing thyroid surgery made the list, as did several devices in the diabetes space.

Approvals Innovation
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