Health Care + Med Tech

Boston Sci, Medtronic Weigh In on Possible FDA Changes

Following a harsh review of the FDA system under which most medical devices are approved for market, Boston Scientific said that it "believe[s] in the strength of the 510(k) process," and Medtronic said it supports regulatory changes that are "in the best interest of patients, including ensuring that innovative therapies reach the market."

Congress Investigates Medtronic Contract Terminations

Senate Finance Committee Chairman Max Baucus seeks information about the medical device giant's decision to cancel contracts with at least two group-purchasing organizations, saying that "reports that this move was fueled by an attempt to discourage transparency and increase costs are troubling."

Study: FDA Should Up Oversight of Med-Tech Devices

A new medical study says that a less rigorous approval process has allowed potentially harmful products to enter the market-but it sparked criticism that its findings contain "factual errors, faulty data analysis, and recommendations that would harm patient access to medical technology with no corresponding safety benefit."
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