Medical Device News
Latest industry news, regulatory updates, and announcements from trusted sources.
Australia starts investigation into OpenAI Medicare breach
Amid this probe, experts point to the importance of airtight AI governance when implementing the technology in high-risk contexts. The post Australia starts investigation into OpenAI Medicare breach a…
Read Full Article →FDA panel endorses GRAIL’s multi-cancer early detection test
The panel voted 7-2 vote in favour of GRAIL’S Galleri multi-cancer early detection (MCED) test’s benefits outweighing its risks. The post FDA panel endorses GRAIL’s multi-cancer early detection test a…
Read Full Article →Xella and ŌURA integrate for women’s health management
Xella Health has announced an integration with ŌURA to deliver a connected precision health experience designed for women's biology. The post Xella and ŌURA integrate for women’s health management app…
Read Full Article →Precision Diabetes and DirectSens to introduce MetMark test in US
Precision Diabetes has signed a US commercialisation partnership with DirectSens for the MetMark clinical test, which measures AHB; 2-HB, a biomarker associated with metabolic dysfunction and future t…
Read Full Article →Navigating Major Inflection Points from IND to Approval
Navigating Major Inflection Points from IND to Approval Learn how biotech and biopharma teams can successfully navigate the critical development milestones that shape a therapy's path from IND to appr…
Read Full Article →CVRx names John Landry as CFO
Landry joins in the aftermath of an investor’s call for the sale of the heart failure device company.
Read Full Article →Telerobotic surgery is advancing around the world. Will the US embrace it?
Medtech companies are preparing for a day when telesurgery, performed by a surgeon often hundreds of miles from the patient, could become a viable option for more people.
Read Full Article →NET Recovery wins FDA breakthrough tag for psychostimulant addiction device
NET Recovery’s device applies neurostimulation to quell cravings in individuals with stimulant use disorder. The post NET Recovery wins FDA breakthrough tag for psychostimulant addiction device appear…
Read Full Article →CMS sets preliminary cuts to Medicare lab reimbursement rates
The American Clinical Laboratory Association warned the steep annual payment cuts threaten patient access to critical lab testing services.
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