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Failure to include women in device trials may be blocking important discoveries in new treatment modalities, CDRH says in commentary on a study published in JAMA: Internal Medicine. Read More
Uncertainty about reimbursement now trumps FDA approval as the major impediment to private funding for new medical technologies, a venture capitalist told lawmakers during a Wednesday hearing on economic and regulatory incentives to encourage device development. Read More
A chief architect of a 2007 law promoting the development of medical devices for children has asked the FDA to provide evidence the agency is making progress on meeting its goals. Read More