In a hearing of the House Government and Oversight Subcommittee, Rep. Paulsen said Acorn Cardiovascular in Minnesota failed to gain FDA approval for a heart failure device after a decade of back-and-forth with the agency and it is now defunct.
Jeffrey Shuren, director of the FDA’s Centers for Devices and Radiological Health, acknowledged that improvements in the approval process could be made but warned that they should not hamper efforts to ensure the devices are safe.
Read the Minneapolis Star-Tribune report on the FDA approval process.
Related Articles on the FDA Approval Process:
FDA Device Approval Process Stifles Innovation, Industry Survey Finds
GAO Publishes Report on FDA’s Premarket Review and Postmarket Safety Efforts
Medical Device Innovation Center in Atlanta Receives $3.6M
At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 11-13 in Chicago, spine surgeons, orthopedic leaders and ASC executives will come together to explore minimally invasive techniques, ASC growth strategies and innovations shaping the future of outpatient spine care. Apply for complimentary registration now.
