The US Medicare agency will end three new technology add-on payments for devices in 2021 but continue payments for a T2 bacteria panel, and is considering the funding for other assays and devices next year.
The Centers for Medicare and Medicaid Services (CMS) may grant new technology add-on payments for several medical devices and diagnostics in FY2021, the agency stated in a proposed rule this week. But CMS will end the payments for three devices as their additional funding time expires next year, the agency said.
New technology add-on payments have expired for remedē Systems, a nerve stimulator sponsored by Respicardia Inc.; Sentinel Cerebral Protection System,...
FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.
The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.
A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.
During a recent FDLI panel, experts discussed the FDA's Home Healthcare initiative, highlighting its potential benefits and challenges. Key issues include usability testing, reimbursement, labeling for home use, and the need for innovation while ensuring patient safety.
FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.
Ultrahuman seeks to “create an environment that aligns with our bodies" by linking environmental parameters collected by Ultrahuman Home to health physiology, measured by the Ultrahuman Ring Air.
The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.
