Medtech leaders urged Congress to ensure coverage of breakthrough devices during a hearing by the House Ways and Means Subcommittee on Health.
Medtech industry leaders testified before the US House Ways and Means Subcommittee on Health about the dire need for breakthrough device coverage.
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International device regulatory group IMDRF has issued a new playbook on “regulatory reliance,” which allows regulators to make use of assessments performed by trusted regulatory partners. The document is the first to offer a detailed guide on developing and implementing these agreements.
A concealed blunt-tip needle that can be inserted into the heart's pericardial space to treat cardiac arrhythmias has received FDA clearance, providing an alternative to catheter-based methods.
Biomedical Alliance’s Tom Melvin is on a mission to assist the European Commission comprehend the clinical gaps during its ‘targeted evaluation’ of the EU's medtech regulations and the pivotal role the EMA could play.
