Regulation

Industry regulatory leaders outline the best approaches for digital health companies looking to make sense of FDA's long-in-the-tooth enforcement discretion guidelines.

The process aims to ensure tools meet NHS standards.

An article in NEJM reports that pulse oximeters missed occult hypoxemia in more Black patients than white.

The eXciteOSA strengthens tongue muscles through electrical stimulation, and comes with a companion app for tracking and sharing progress.

The move has been lauded by the GMDN Agency as a “valuable resource for the UK healthcare sector”.

Last week the European Commission signed off on the merger, on the condition that Google follows through with a handful of commitments.   

As the agency's workload swells with the weight of a public health emergency, digital health companies on a timeline should consider whether their products truly warrant a regulatory submission, writes Epstein Becker & Green's Bradley Merrill Thompson.

The regulator imposed a series of requirements for the tech companies that must be followed for at least 10 years.

Alongside step-by-step instructions, the Ellume COVID-19 Home Test's accompanying app automatically reports users' results to the relevant public health authorities.

Mahana Therapeutics' Parallel is a three-month digital treatment that logs patients' symptoms to deliver relevant guidance and teach them condition-management skills.