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Approvals

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Global Device Approvals, Weekly Snapshot: Tandem Diabetes Win

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, Tandem Diabetes Care gained US FDA go-ahead for the first "interoperable" insulin pump.

Approvals Research & Development Diabetic Care
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Global Device Approvals, Weekly Snapshot: Tandem Diabetes Win

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, Tandem Diabetes Care gained US FDA go-ahead for the first "interoperable" insulin pump.

Approvals Research & Development

Global Device Approvals, Weekly Snapshot: Spine Device Duo

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, two spine device approvals from US FDA, and a CE mark for a new drug-eluting stent.

Approvals Research & Development

Medtronic Expands Indication For Pipeline Flex Embolization Device

Medtronic's Pipeline Flex device is now labeled for treating patients with small or medium wide-necked brain aneurysms following US FDA approval for an expanded indication.

Approvals Neurology

Global Device Approvals, Weekly Snapshot: First-In-Class STI Diagnostic

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, only one novel device approval made the list: a new sexually transmitted infection diagnostic from Hologic.

Approvals Research & Development

US FDA Approves Abbott’s Sensor-Enabled TactiCath AF Catheter

The TactiCath - Sensor Enabled contact-force ablation catheter is indicated for cardiac electrophysiological mapping and the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. It adds to Abbott EnSite Precision cardiac mapping system.

Approvals Innovation

Zimmer Biomet Wins US FDA Nod For Robotically Assisted Knee Replacement System

Zimmer Biomet announced 510 (k) clearance for its Rosa Knee system for robotically assisted total knee replacement surgery.

Approvals Orthopedics

Global Device Approvals, Weekly Snapshot: A Quiet Period

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker.

Approvals Research & Development

2018 US Device Approvals: The Year Of De Novos And Digital Health

It was another record year for novel device approvals by US FDA, driven by the big uptick in de novo classifications for low-to-moderate-risk devices in 2018. Meanwhile, original PMA approvals dropped significantly. An analysis and infographic on FDA device approval trends in 2018.

Approvals FDA

2018 Global Approvals Analysis: Emerging-Market Regulators And Companies Make Their Presence Felt

The list of medical device approvals outside the US captured by Medtech Insight's Approvals Tracker in 2018 was shorter than in 2017, but it includes approvals from 14 different territories – more than one-fifth of the approvals came from emerging markets – covering more than 50 different indication categories.

Approvals Emerging Markets
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