digital health regulation

Digital health innovation consultant Naomi Fried highlights trends to watch among pharmas interested in digital health technologies.

This week at the EIT Health Summit in Paris entrepreneurs, industry players, regulators and investors came together to discuss the opportunities for health innovation in Europe, and its relationship to the US market. 

Representatives from cardio monitoring device maker Eko and the FDA offer advice for medical device startups gearing up for their first approval.

Epstein Becker & Green's Bradley Merrill Thompson explains why the FDA PreCert Program's built-in subjectivity and bias toward established entities should worry the healthcare and medical technology industry.

The new guidances are intended to provide clarity on which products are or are not subject to regulatory enforcement, and to bring the agency’s efforts into compliance with provisions of the 21st Century Cures Act.

At BIO 2019 in Philadelphia, a panel of industry experts discussed their experiences with the FDA's pilot program; ambiguities in drug, device and software pathways; and the hurdles digital health regulation has yet to properly address.

Companies planning an upcoming De Novo or 510(k) submission for their software medical device are eligible, but participation will not yield precertification.

A new report from PwC predicts that new and proposed FDA regulations could open up doors for pharmaceutical companies looking to develop digital tools. 

Released yesterday, the document outlines FDA's preference toward single applications for combination products.

To encourage healthcare technology innovation and update the 510(k) pathway, the regulatory agency said that it will soon release measures aimed to sunset predicate devices that are over a decade old.