Alignment with other relevant regulations, including medtech, should be a main priority for the European Medicines Agency when developing guidance on the use of artificial intelligence, according to MedTech Europe’s director for international affairs.

In the EU, notified bodies are usually designated for a wide spectrum of testing of different types of medical devices under the Medical Device Regulation. The latest organization to be named, however, is a specialist.

A report from MITRE recommends mutual aid partnerships between large and small HDOs to secure legacy medical devices.

El Salvador has approved a new law that will establish a new regulatory body responsible for authorizing medicines and setting prices.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights interviews with Abbott’s head of Lingo Biowearables and top executives at Twin Health. Reed Miller provides an update on J&J MedTech’s launch of the Ottava soft-tissue robotic surgery system and Barnaby Pickering talks about his recent interview with Leo Grady, former CEO of Paige AI, to talk about his new start-up Jona.

The DTx company’s revenue grew some 500% to $702,000 in the fiscal 2023 third quarter, reflecting its direct-to-consumer launch of EndeavorOTC to adult ADHD patients in June under a US FDA enforcement policy established for digital health devices during the COVID-19 public health emergency. That policy has since sunset, and Akili has submitted a 510(k) application to the agency for review.

Experts lamented the lack of consensus standards for AI medical devices, which they said could pose harm to innovators.

Medtech Insight spoke with chief AI officer for Medtronic's Endoscopy unit, Ha Hong, about his vision for integrating AI technologies into medical devices, the challenges and benefits of using AI, the importance of responsible use of AI, generative AI and the role of AI in the future of health care.

The Klinrisk model, a new AI-driven tool developed to predict the progression of chronic kidney disease, proved highly effective in a recent study. The model’s scientific founder told Medtech Insight the novel technology has the potential to help healthcare professionals better identify patients most at risk.

Medtech Insight spoke with chief AI officer for Medtronic's Endoscopy unit, Ha Hong, about his vision for integrating AI technologies into medical devices, the challenges and benefits of using AI, the importance of responsible use of AI, generative AI and the role of AI in the future of health care.

In this podcast, Medtech Insight speaks to Andy Molnar, CEO of the digital therapeutics alliance; Joel Morse, CEO and co-founder of Curavit and Owen McCarthy, CEO and co-founder of MedRhythms. The trio discuss the current situation surrounding digital therapeutics, and where they believe they are headed in the coming years.

In 2024, Visana Health will leverage $10.1m in seed funding to expand its holistic, value-based virtual clinic to add conditions that differently or disproportionally affect women and provide at-home testing. Health plans and employers are taking notice, and Visana’s CEO expects further investment to follow.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights interviews with Abbott’s head of Lingo Biowearables and top executives at Twin Health. Reed Miller provides an update on J&J MedTech’s launch of the Ottava soft-tissue robotic surgery system and Barnaby Pickering talks about his recent interview with Leo Grady, former CEO of Paige AI, to talk about his new start-up Jona.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights interviews with behavioral health experts on implementing AI solutions to help ease the administrative burden on clinicians as well as recent coverage from the LSX Congress USA and HLTH conferences. Reed Miller discusses findings of EY’s annual pulse of the medtech industry report and Hannah Daniel discusses FDA guidance on regulating AI/ML.

In this special podcast, Medtech Insight managing editor Elizabeth Orr talks to consultant Steve Silverman about the FDA’s current position on real-world evidence and real-world data, as well as how manufacturers can best put the evidence types to use.

In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to Washington Analysis vice president and senior healthcare analyst John Leppard about the Center for Medicare and Medicaid’s Transitional Coverage Of Emerging Technologies pathway, or TCET. He breaks down the pathway and discusses its pros and cons, as well as potential next steps for the agency. We also explore the history of breakthrough device coverage as well as the challenges for coverage of digital health devices.

Alignment with other relevant regulations, including medtech, should be a main priority for the European Medicines Agency when developing guidance on the use of artificial intelligence, according to MedTech Europe’s director for international affairs.

In the EU, notified bodies are usually designated for a wide spectrum of testing of different types of medical devices under the Medical Device Regulation. The latest organization to be named, however, is a specialist.

A report from MITRE recommends mutual aid partnerships between large and small HDOs to secure legacy medical devices.

3M’s health care company spin-off is expected to be launched in the first half of 2024 under the name Solventum. 

A rundown of the medtech executive moves in October 2023, including new CEOs at SciBase, Acarix, and Axion.

El Salvador has approved a new law that will establish a new regulatory body responsible for authorizing medicines and setting prices.

Medtech Insight's News We're Watching highlights medtech industry news developments you may have missed over the last few weeks.

Smith & Nephew said it will acquire sports medicine technology company CartiHeal for up to $330m to boost its knee injury repair portfolio.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights interviews with Abbott’s head of Lingo Biowearables and top executives at Twin Health. Reed Miller provides an update on J&J MedTech’s launch of the Ottava soft-tissue robotic surgery system and Barnaby Pickering talks about his recent interview with Leo Grady, former CEO of Paige AI, to talk about his new start-up Jona.

The DTx company’s revenue grew some 500% to $702,000 in the fiscal 2023 third quarter, reflecting its direct-to-consumer launch of EndeavorOTC to adult ADHD patients in June under a US FDA enforcement policy established for digital health devices during the COVID-19 public health emergency. That policy has since sunset, and Akili has submitted a 510(k) application to the agency for review.

The EU notified body association, TEAM-NB, is working hard to support industry with its MDR and IVDR compliance efforts. Its first technical documentation training session highlighted where help is likely to be most needed.

Experts lamented the lack of consensus standards for AI medical devices, which they said could pose harm to innovators.