2016 finished with just two more non-US medical device approvals than 2015; December was by far the slowest month of the year for approvals from outside the US with just 11.
[Editors' note: Check out our 2016 Medical Product Approvals infographic and our analysis of 2016 approval trends in the US.For sortable and searchable tables of all 2016 US and non-US approvals and clearances, check out ourApprovals Tracker.]
2016 started on pace for a big year of medical device approvals outside the US, but the pace peaked in...
Clairity’s "first-in-class" mammography-based AI screening tool, Clairity Breast, provides "equitable risk assessments," expanding access to lifesaving early detection for breast cancer, said company founder Connie Lehman.
Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.
The US FDA has approved the Teal Wand, the first at-home cervical cancer screening device. Capable of detecting preclinical cancer with 96% accuracy, it will launch in California in June and expand nationwide soon after.
NeuroOne is preparing to submit its OneRF Trigeminal Nerve Ablation System to the US FDA for treating trigeminal neuralgia, a chronic facial pain condition. CEO Dave Rosa told Medtech Insight that he expects a possible product launch by fall 2025.
