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A provision to expand Sunshine Act industry reporting requirements for companies in the Senate-passed “Opioid Crisis Response Act” has caught criticism from the device sector, despite overall industry support for the legislation.
Latest From United States, Policy & Regulation
A newly finalized guidance document from US FDA explains how the agency will evaluate benefit and risk questions for substantially equivalent products with differing technological characteristics.
The recent US FDA de novo approvals for heart-rhythm analysis software on Apple's latest Apple Watch, which took about 30 days from submission to a decision that aligned with Apple's high-profile launch event, raised eyebrows in the medtech industry. Some in industry are concerned that the tech giant received preferential treatment over smaller companies, setting a bad precedent. But some say it could be a positive sign for the digital health industry at large.
A device manufacturer wouldn’t violate anti-kickback law by offering hospitals a refund if their joint replacement fails for patients, the Department of Health & Human Services’ Office of the Inspector General said in a recent advisory opinion.
The top health official at the White House Office of Management and Budget says the Trump administration is committed to clearing barriers that stand in the way of reimbursement for new medical technology. “We’re doing a lot of work on medical device stuff that nobody knows about, trying to figure out how America can maintain our dominance," Joe Grogan said Sept. 20.
Greg Crist, the top public affairs executive at AdvaMed, is stepping in to head the trade group's government affairs operations, as JC Scott departs to lead the Pharmaceutical Care Management Association.
The device industry is praising passage of “The American Innovation Act” by the US House. The bill is intended to promote new business start-ups – including fledgling medtech companies – by allowing certain tax deductions for net-operating losses.
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