In a Tuesday webinar from the Alliance for a Stronger FDA, CDRH head Jeffrey Shuren said that a “politicized and toxic” environment in Washington could limit the agency’s ability to keep up with innovation and responding to new threats.

Medical products imported from China are among a broad range of items that will be subject to higher tariffs under new federal guidelines. The plan will raise tariffs on some forms of personal protective equipment (PPE) to 25%; additionally, tariffs on syringes and needles will be set at 50%.

The US FDA is warning against the use of Cue Health’s COVID-19 test, which was developed and manufactured with $481m of government funding. A recent inspection found unauthorized alterations to the product.

As a biomedical engineer, Blair Hirst saw how health technology could help patients – and how some communities were slowest to benefit. As founder of the Digital Health Review, she now works to improve equity in health care spaces.

This week, MHRA and NICE released results from their first survey of potential digital health tool users; the FDA warned against using Getinge/Marquet cardiac devices; and Illumina announced plans to hand its Grail spin-off to existing shareholders.

The designation makes the watch's AFib history feature the first digital health tool to be qualified under the US FDA’s Medical Device Development Tools program, meaning it can be used in research during the development of certain cardiac devices.