Podcast: CEO Advises Digital Health Companies To Get Regulatory Help

Spencer Hutchins, whose company Reflexion Health's rehabilitation gaming software Vera was recently cleared by FDA says companies like his often have the engineering chops to build medical device software but not the regulatory know-how.

Directly download the entire podcast here

.

More from Regulation

More from Policy & Regulation

Medicare Tricuspid Regurgitation Coverage Decision Big Win For Abbott

 

Medicare beneficiaries with tricuspid regurgitation will now have access to an innovative treatment from Abbott that offers a minimally invasive alternative to open-heart surgery.

Warning Letters – June 2025

The US FDA posted eight device-related warning letters in June, touching on industry sectors from urinalysis test strips to ophthalmic devices.

Study: FDA’s Breakthrough Path Speeds Access, But Raises Safety Questions

 
• By 

Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.