FDA released its highly anticipated proposals for reforming the 510(k) program last week, and industry reps acknowledged that many of the individual recommendations could benefit companies
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With medtech businesses typically managing investment cycles on a three- to five-year basis, local regulatory processes and forward costs of market entry must offer an attractive environment in which companies can plan for growth, says McDermott Will and Emery’s partner and head of healthcare and life sciences, Sharon Lamb. Broad-scale improvements to NICE’s evaluation offerings would similarly enhance the UK’s value to innovators.
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.
SS Innovations announced plans to file a de novo application with the US FDA for its SSi Mantra 3 surgical robot, already approved for marketing in six countries. The Florida-based firm also plans to pursue the CE mark for European commercialization.
