In the first episode of new podcast series Medtech Connect, Medtech Insight regulatory reporter Hannah Daniel interviews Foley and Lardner partner Kyle Faget about the complexities behind regulating software as a medical device (SaMD). Many companies are unsure if their software is even regulated by the FDA, let alone how to go about the clearance process. From managing cybersecurity risks to navigating digital health policy, Faget does it all, and she gives us insight into the regulatory landscape of SaMD in this month’s episode.
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New notified body is listed under the EU Medical Device Regulation after no designations for a year.
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.
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.
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.
