US FDA Adds 14 New Regulatory Tools To Help It Review Medical Devices
The tools include new laboratory methods, and computational models and simulations give the agency more capabilities to test and validate data in premarket submissions.
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The regulatory tools are for use in medical device development.
The sixth Medical Device Development Tool qualified by the US FDA allows makers of artificial pancreases to provide data on psychosocial effects and quality-of-life changes of patients using their product. Ultimately, it may be the key to whether the agency allows the product on the market or not.
Mercom Capital Group says telehealth VC deals continue to dominate the digital health sector which is poised to break new records this year. Almost half of telehealth investments from the past decade came in just the past year as the world grapples to work remotely during the coronavirus pandemic.