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Approvals

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Q3 US Device Approvals Snapshot: Apps Up, Original PMAs Down

Mobile apps made major headway into the world of US FDA regulation in the third quarter, with de novo go-aheads for two Apple Watch heart-rhythm apps and the first FDA approval of a smartphone app to support contraception. Meanwhile, original PMA-approval volumes continue to lag in 2018. Here's an infographic to spotlight US device approval trends during the third quarter, July through September.

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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

Global Device Approvals, Weekly Snapshot: Diabetes Tech In Canada

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Among the four added this week, Tandem Diabetes and Medtronic both gained integrated insulin pump system approvals in Canada.

Approvals Diabetic Care

Q3 US Device Approvals Snapshot: Apps Up, Original PMAs Down

Mobile apps made major headway into the world of US FDA regulation in the third quarter, with de novo go-aheads for two Apple Watch heart-rhythm apps and the first FDA approval of a smartphone app to support contraception. Meanwhile, original PMA-approval volumes continue to lag in 2018. Here's an infographic to spotlight US device approval trends during the third quarter, July through September.

Approvals FDA

Q3 Global Device Approvals Shapshot: Another Big Quarter For Coronary And Peripheral Intervention Approvals

The third quarter of 2018 brought 60 approvals from outside the US, including 31 in Europe, according to Medtech Insight's Approvals Tracker. Among those approvals, six were for devices to treat coronary artery disease; the second most common indications were peripheral disease and catheter complications. Outside of Europe, India recorded the most non-US approvals in the quarter with eight.

Approvals Clinical Trials

Global Device Approvals, Weekly Snapshot: Seeing And Hearing

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. A smart contact lens, self-fitting hearing aid and laser eye surgery device are among the new additions to the tracker.

Approvals Innovation

Global Device Approvals, Weekly Snapshot: Measuring 'Minimal Residual Disease' With NGS

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Among the four added this week, Adaptive Biotechnologies gets FDA nod for a "minimal residual disease" next-gen sequencing platform in oncology, and more from Europe and Mexico.

Approvals Research & Development

Global Device Approvals, Weekly Snapshot: Transcranial Stimulator For Alzheimer's, And More

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Among the five added this week, Neuronix's NeuroAD Non Invasive Cortical Enhancer technology was approved in Australia for use in Alzheimer's patients, in combination with "tailored cognitive therapy."

Approvals Research & Development

Global Device Approvals, Weekly Snapshot: Apple Watch Wins FDA Love

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker. Tech giant Apple led this round's news with two US FDA approvals for heart-rhythm-analysis apps embedded in the new Apple Watch.

Approvals Digital Health

Israeli Robotics System Steers Closer To European Market

XACT Robotics has secured a CE mark for its XACT image-guided robotic needle steering system for CT-guided percutaneous procedures in the abdomen. The company is hoping to formally launch XACT by 2019 while expanding the system to additional clinical indications, including spine, and lung procedures.

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