Common technical document submission will remain voluntary, but recommended, according to FDA's draft guidance on general considerations regarding CTD submission.

In this week’s podcast, Medtech Insight's managing editor Marion Webb and deputy editor Reed Miller discuss highlights from the recent J.P. Morgan Healthcare and North American Neuromodulation Society (NANS) virtual meetings. London, UK-based reporter Barnaby Pickering profiles start-up CorWave SA, which developed a left ventricular assist device for treating end-stage heart failure.

Tom McLain tells how the new MCIT policy from the US Medicare agency – and winning support from Congress – will guarantee Medicare coverage for his company’s product, an artificial intelligence-enabled in vitro diagnostic platform.