Calling himself a “wartime president,” Donald Trump on 18 March invoked the Defense Production Act to push US manufacturers to produce medical products needed to combat COVID-19 – even if those companies aren’t device makers. Trump later signed an Executive Order giving Health and Human Services secretary Alex Azar the power to “allocate materials, services and facilities as deemed necessary or appropriate” – all actions covered by the DPA.
Calling himself a “wartime president,” Donald Trump on 18 March invoked a Korean War era law to push US manufacturers to produce medical products needed to combat COVID-19 – even if those companies aren’t device makers.
“I will be invoking the Defense Production Act, just in case we need it. It can do a lot of good things if we need it,” the president said at...
The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel
The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.
During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.
Surgify Medical’s selective drill tip, Surgify Halo, is “an obvious choice for surgeons,” said Boris Hofmann, head of ZEISS Ventures and lead investor in the company’s series A funding round.
German Bionic’s new exoskeleton Exia helps healthcare practitioners, nurses, and other caregivers to lift and move patients by supporting muscle movement and reducing the risk of injury.
The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.
TRiCares presented data from the first-in-human study for its tricuspid valve replacement system – Topaz – at EuroPCR 2025 on 22 May.
