The second quarter of 2018 brought 62 approvals from outside the US, including 46 in Europe, according to Medtech Insight's Approvals Tracker. Among those approvals, 14 were for devices to treat coronary artery disease, and the second most-common indications were obesity and soft-tissue repair. Outside of Europe, Japan had the most non-US approvals in the quarter with five.
Devices to treat coronary artery disease accounted for 14 of the 62 medical device approvals from outside the United States recorded in the second quarter of 2018 by Meddevicetrackerand Medtech Insight's Approvals Tracker, making it by far the most frequently non-US approved indication category during the quarter.
Approvals of such devices over the last three months include Corindus Vascular Robotics Inc.'s CorPath GRX vascular robotic system,...
The US FDA has announced classifications for five device types, including four diagnostics as well as a hand cream to protect healthcare workers exposed to radiation. Two of the products are newborn screening tests.
Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.
Medtronic is teaming up with IRCAD North America to build high-tech training and education experiences for surgeons and medical professionals in cardiovascular, neuroscience, and minimally invasive surgical specialties. The move could also further position Medtronic to seize on the growing robotics
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.
After multiple warning letters and safety communications, the US FDA has decided to block the import of certain endoscopes from Olympus. In total, the agency’s action pertains to 58 device models manufactured by the Japanese firm used in urinary, respiratory, abdominal and pelvic procedures.
Healthcare product industries await publication of the NHS 10-Year Plan, due out the coming days, which will focus on health generally not just the NHS, UK health secretary Wes Streeting said during a final prelaunch event on 24 June.
From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.
