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Approvals

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Global Device Approvals, Weekly Snapshot: July 23-29, 2018

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker. This week, Abiomed's Impella enters India, and more.

Approvals Research & Development Medical Device
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Global Device Approvals, Weekly Snapshot: Aug. 13-19, 2018

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker. This week, two Health Canada approvals, and more.

Approvals Research & Development

Senseonics Rolls Out Eversense Subcutaneous Continuous Glucose Monitor

US FDA approved the Eversense CGM System for continually measuring glucose levels in adults with diabetes for up to 90 days, and the company is working on clinical evidence to support a 365-day indication, as well as working with Roche and Beta Bionics to include its sensor technology in fully integrated artificial pancreas systems

Innovation Clinical Trials

OCD Indication Approved For Brainsway TMS Device

US FDA used its de novo review pathway to approve Brainsway Ltd.’s Brainsway Deep Transcranial Magnetic Stimulation System to treat obsessive compulsive disorder.

Approvals United States

Endomag Outlines Commercial Ambitions Following Landmark FDA Approval

Endomag is making plans to shake up the US breast cancer market with its Sentimag and Magtrace combination breast cancer system, which recently earned US FDA approval. The company recently raised $10m to scale its commercial operations.

Companies Commercial

Global Device Approvals, Weekly Snapshot: Aug. 6-12, 2018

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker. This week, a new microstent for glaucoma was approved by US FDA.

Approvals Ophthalmology

FDA Approves Birth Control Mobile App, Vaginal Ring

US FDA announced the approval of the first direct-to-consumer mobile medical app that can prevent pregnancy via fertility awareness tracking. The app, Natural Cycles, has been criticized in Europe after some users experienced unplanned pregnancies. On the same day, the agency approved the first contraceptive vaginal ring that can be reused for an entire year.

Medical Device Gynecology & Urology

Device Week, Aug. 10, 2018 – Cancer Center Steps Up To Pass Combo Product

On this week’s podcast, Medtech Insight’s Catherine Longworth and Ferdous Al-Faruque talk about surgical guidance company Endomag, which recently secured a landmark approval from US FDA for its combination breast cancer product Sentimag and Magtrace.

Device Week Combination Products

New Cancer Center Played Pivotal Role In Endomag's Success

US FDA's new Oncology Center for Excellence brought in key experts to help review and approve Endomag's new Magtrace and Sentimag System combination product to help surgeons trace and remove breast tumors. The case highlights how disease-specific centers could change the way the agency reviews products, and it also spotlights the agency's recent efforts to improve combination product reviews. Check out our Q&A with FDA's Binita Asher.

Combination Products Cancer

ElectroCore Brings Next-Gen Vagus Nerve Stimulator To US With Innovative Sales Channel

US FDA cleared the gammaCore Sapphire non-invasive vagus nerve stimulator for the acute treatment of pain associated with migraine and episodic cluster headache. Electrocore also recently signed a deal with UpScript to provide a direct-to-patient sales channel for gammaCore.

Approvals Commercial
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