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.

Acquiring Clarion Brands from Swander Pace, Bridges Consumer Healthcare adds portfolio of OTC and supplement brands for symptoms including tinnitus, urinary pain relief and excessive sweating.

The document from the Medical Device Innovation Consortium aggregates external data sources, various statistical methods and lays out other considerations for sponsors to help speed up and bolster a premarket product application to the US FDA.