FDA said its new plan, which can’t be released as a formal draft guidance for another 60 days, would establish a more level playing field between test-kit makers and labs, while being flexible when there is not an FDA-approved alternative to an lab-developed test.
FDA unveiled a long-anticipated proposed framework
for regulating laboratory-developed tests July 31.
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Already a subscriber?
Partnership, positive communication and passion were all key in establishing a regulatory route for groundbreaking genetic testing technology for hereditary diseases. So said Fulgent Genetics’ executives interviewed by MTI about their technology’s development pathway.
The medtech industry, eagerly awaiting clear guidance on how healthcare data can be shared and help drive innovation, can have its say.
Electronic instructions for use are becoming increasingly prevalent in the medtech world, but so far in the EU do not extend to non-professional users.
Expect fresh scrutiny on skin substitute payments as the Office of the Inspector General found Medicare reimbursement for the products has continued its rapid increase despite fraud and abuse concerns.
Fresh off de novo clearance, Biolinq plans to launch its needle-free CGM for type 2 diabetes not on insulin in early 2026. Pricing has not been disclosed, but “won’t be too far apart” over rivals Abbott’s Lingo and Dexcom’s Stelo CGMs, CEO Rich Yang said.
The Daxor Blood Volume Analysis (BVA) is aimed at improving care for heart failure patients. It will allow blood volume to be measured from the patient’s bedside for the first time and is also significantly faster than earlier testing methods.
The US FDA is seeking public input on practical approaches to evaluating the performance of AI-enabled medical devices. The agency says it wants to build off insights gained from a public advisory committee last year that discussed how best to evaluate these devices once they are in use.
