Medtech Insight - News And Expert Analysis For Medtech Decision Makers since 1975

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.

FDA Commissioner Marty Makary stated in a new interview that there will be no significant reorganization of the agency, despite earlier reports. Using his “guiding principles” of common sense and gold-standard science, he plans to focus on reforms including improved pathways for medical AI and food safety as well as addressing employee morale.

New continuous glucose monitoring manufacturing site in Indiana is part of Roche’s plan to boost its US presence. Roche’s launch of Accu-Chek SmartGuide system last year with AI-powered prediction capabilities puts it as a key differentiator from competitors such as Abbott and Dexcom.

Back-to-back meetings at LSX? No time to attend the innovator showcase? Here is what you might have missed from medtech innovators at the LSX World Congress Europe on 29 April.

As the EU Life Sciences Strategy aims to drive innovation, the medtech sector is pushing for a pivotal role in a mission intended to embrace green and digital transitions, address regulatory obstacles and reduce dependency on external sources.

Vendor exhaustion, insufficient clinical-grade evidence, and outdated risk management are some of the reasons the NHS is struggling to adopt AI. Haris Shuaib, CEO of Newton's Tree, shared his insights with the audience at the “Next Frontier of Medical AI” event held at DAC Beachcroft's London office on 23 April.

Back-to-back meetings at LSX? No time to attend the innovator showcase? Here is what you might have missed from medtech innovators at the LSX World Congress Europe on 29 April.

HistoSonics, which developed a noninvasive technology to destroy tumor cells, reports 90% local tumor control at 12-month follow-up in the #HOPE4Liver Trial. The Edison System, cleared by the US FDA in late 2023, is also being evaluated for kidney and pancreatic tumors. CEO Mike Blue said the medtech is financially secure but watching public markets as it considers an IPO.

Vendor exhaustion, insufficient clinical-grade evidence, and outdated risk management are some of the reasons the NHS is struggling to adopt AI. Haris Shuaib, CEO of Newton's Tree, shared his insights with the audience at the “Next Frontier of Medical AI” event held at DAC Beachcroft's London office on 23 April.

Back-to-back meetings at LSX? No time to attend the innovator showcase? Here is what you might have missed from medtech innovators at the LSX World Congress Europe on 29 April.

Medtronic says results from a recent study on the Hugo robotic-assisted surgery system substantiate its safety and effectiveness for various urological procedures. The company also announced it has submitted the system to the FDA for approval for a urological indication.

Medtech Insight sat down with Jared Bunch, chair of AF Center of Excellence Task Force, at HRS 2025 to discuss the newly HRS released framework for Afib Center of Excellence and get his perspective on the role industry could play to help clinicians improve patient outcomes.