After a series of high-profile recalls during the 2000s, Congress requested a GAO investigation to review FDA’s oversight of medical device recalls. GAO reviewed 53 Class I (high-risk ...

if it is a medical device exempt from pre-market review. The uses cleared or approved by the FDA. Its target patient population. Its cleared or approved route of administration. Some information ...

The FDA’s Breakthrough Device Designation ... its development and review process, supports reimbursement and timely access for patients and healthcare providers. Spryte Medical is also pleased ...

--(BUSINESS WIRE)--Archimedic, a medical device development firm that provides ... During the month, Archimedic will be regularly posting on LinkedIn highlighting many of the 24 forms included ...

Officials with the Centers for Medicare & Medicaid Services (CMS) wrote in the Journal of the American Medical Association its vision for a new pathway for the device review process that will be ...

For some medical ... that the device, including things like implantable heart defibrillators or stents, is safe and effective. That process is roughly equivalent to how regulators review new ...