The US Food and Drug Administration is set to expand a pilot program aimed at speeding up the development of innovative medical devices. The agency will begin enrolling more devices in the Total Product Lifecycle Advisory Program, which the agency rolled out in January.
The US Food and Drug Administration recently announced it is set to expand the Total Product Lifecycle Advisory Program (TAP) by enrolling devices from the Office of Neurological and Physical Medicine Devices (OHT5) beginning 1 October.
Currently, there are no neurological devices in the program.
The US Department of Health and Human Services has proposed cutting Medicare reimbursement for skin substitutes used in chronic wound care by up to 90%. The change aims to address rising costs but could harm patient access and treatment quality, prompting concerns from industry stakeholders.
The UK government’s response to MHRA public consultation on risk proportionate device routes to market and physical UKCA markings adds momentum to drive for modern, agile system. Another consultation in late 2025 will propose indefinite recognition of CE-marked devices in Great Britain.
The EU’s extra layer of checks on clinical evidence is proving a difficult, and sometimes humiliating process, for many device companies whose products have come under the spotlight.
A federal court in Illinois ruled against SurModics and BC Holdings' request for FDA documents to support a proposed merger. The FTC has challenged the merger, claiming it threatens competition in hydrophilic device coatings. The ruling may indicate the FTC is likely to succeed.
The EU’s extra layer of checks on clinical evidence is proving a difficult, and sometimes humiliating process, for many device companies whose products have come under the spotlight.
A federal court in Illinois ruled against SurModics and BC Holdings' request for FDA documents to support a proposed merger. The FTC has challenged the merger, claiming it threatens competition in hydrophilic device coatings. The ruling may indicate the FTC is likely to succeed.
An “NHS Innovator Passport” that allows quicker uptake of proven technologies across the national healthcare provider is one of the wins the UK government is looking to score from its new Life Sciences Sector plan. The plan majors on prevention. The medtech industry has given it a cautious welcome.
