Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
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.
Latest From Approvals
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.
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
US FDA used its de novo review pathway to approve Brainsway Ltd.’s Brainsway Deep Transcranial Magnetic Stimulation System to treat obsessive compulsive disorder.
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.
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.
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.
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.
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.
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.
All set! This article has been sent to firstname.lastname@example.org.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.