Nine companies are asked to volunteer for a pilot program that could lead to a new pathway for sponsors of digital health products. Under the plan, the agency would allow firms to market a product with fewer if any pre-market review requirements based on trust developed in the company's software design and testing. If the project works out, FDA digital health leader Bakul Patel tells Medtech Insight, the agency hopes it will attract more non-traditional medical device firms that specialize in software development.
Calling it a "once in a lifetime opportunity," FDA's top digital health official is encouraging companies to sign up for a pre-certification pilot that could allow them to get health software to market sooner and, in some cases, without filing a pre-market application.
After months of floating the idea to industry, FDA announced July 27 that companies can sign up for a pilot of the Digital Health Software Precertification Program ,or...
TRiCares presented data from the first-in-human study for its tricuspid valve replacement system – Topaz – at EuroPCR 2025 on 22 May.
The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.
Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.
