Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
3. FDA updates medtech fast-track review for rare treatments
MASSDEVICE ON CALL — U.S. healthcare regulators released new documents in efforts to clarify the FDA’s Humanitarian Device Exemption pathway, a less-stringent review process for medical devices that treat rare diseases.
The FDA issued a new draft guidance that would allow devices to bypass some of the required safety and efficacy hurdles if it is intended to treat a population of less than 4,000 patients. Read more
2. The making of an icon | Dr. Tom Fogarty’s obsession with innovation
It’s been 50 years since Dr. Tom Fogarty invented the catheter-based treatment for blood clots that’s now the standard of care. At 80, it would be a cinch for Fogarty to retire to his California vineyard and bask in the reflected glory of his accomplishments.
But Fogarty, a serial entrepreneur with more than 30 medical device startups under his belt, told MassDevice.com recently that he has no plans to slow down until he’s 6 feet under. Read more
1. Abiomed jumps on Medicare reimbursement news
Abiomed said today that the Centers for Medicare & Medicaid Services plan to maintain the reimbursement rate for treatment with its Impella heart pump when new rates go into effect this fall.
The federal healthcare bureau is preparing to move from the ICD-9 slate of reimbursement codes to the ICD-10 version in October. The changeover won’t affect the rate for reimbursement for treatment with the Impella device, a catheter-based pump used to assist the heart in patients with heart failure. Read more