Featured Stories

Shattered Glass Or Broken Ladder: Is the Medtech Industry Becoming More Equal For Women?
Medtech promotes more women to managerial roles than other industries, but senior leadership positions see a significant drop in women representation, indicating a "broken rung" higher up in the leadership ladder.

Founder Of AI Tool For Predicting Progression Of Chronic Kidney Disease Discusses Technology
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.

AMA Establishes Principles For ‘Augmented Intelligence’
The American Medical Association has written a set of principles for augmented intelligence (AI) development and deployment in health care. The organization hopes these principles can shape “a consistent governance structure for advancements in health care technology.”

FDA Leaves Global Harmonization Working Party, Will Focus International Harmonization Efforts
Three years after joining, the US FDA announced its withdrawal from the Global Harmonization Working Party and intention to focus its work on medical device harmonization through its collaboration with the International Medical Device Regulators Forum.
Spotlight On Medtech Meetings
Israeli Medtech Leaders Say War Is Impacting Companies, Driving Industry Humanitarian Effort
Two executives of Israeli-based medtech companies say the Hamas-Israeli war is having an impact on their companies, with employees being called up as reservists and others needing accommodations. It also has galvanized companies to join forces to support health and humanitarian needs during the crisis.
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Medtech Insight Podcasts
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Medtech Connect Episode 10: Breaking Down The Transitional Coverage Of Emerging TechnologiesListen to Medtech Insight podcasts for our perspectives on regulation, policy, quality, R&D and key commercial topics.
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Global Device Regulation

Medtech Industry Weighs In On EMA’s AI Regulation Proposals
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.

Latest Notified Body Designated Under the EU’s MDR Is A Software Specialist
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.

Report: HDO Mutual Aid Can Provide Legacy Device Security
A report from MITRE recommends mutual aid partnerships between large and small HDOs to secure legacy medical devices.

El Salvador Sets Up New Regulatory Body To Oversee Medicines & Devices
El Salvador has approved a new law that will establish a new regulatory body responsible for authorizing medicines and setting prices.
Digital Health

Digital Health Roundup: Black Friday Hits – Digital Twins, Biowearables, Robotics, Cardiology
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.

Akili Awaits FDA Feedback On Data Needs For OTC Marketing Of ADHD Digital Therapeutic
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.

Policy Misalignment Is Harming AI Development, Experts Say
Experts lamented the lack of consensus standards for AI medical devices, which they said could pose harm to innovators.

Medtronic Endoscopy’s AI Head Contemplates ‘Responsible Use Of AI’
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.
Interviews

Founder Of AI Tool For Predicting Progression Of Chronic Kidney Disease Discusses Technology
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.

Medtronic Endoscopy’s AI Head Contemplates ‘Responsible Use Of AI’
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.

Podcast: Discussing The Potentials Of And Challenges For Digital Therapeutics
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.

Visana Health To Scale Virtual Women’s Health Clinic To Provide ‘Whole Human Being’ Care
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.
Podcasts

Digital Health Roundup: Black Friday Hits – Digital Twins, Biowearables, Robotics, Cardiology
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.

Digital Health Roundup: HLTH, LSX, AdvaMed; FDA And Pre-Determined Change Control Plans
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.

Podcast: The Realities Of Real-World Evidence
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.

Medtech Connect Episode 10: Breaking Down The Transitional Coverage Of Emerging Technologies
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.
Recent Stories

Medtech Industry Weighs In On EMA’s AI Regulation Proposals
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.

Latest Notified Body Designated Under the EU’s MDR Is A Software Specialist
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.

Report: HDO Mutual Aid Can Provide Legacy Device Security
A report from MITRE recommends mutual aid partnerships between large and small HDOs to secure legacy medical devices.

Solventum: The Identity Of 3M’s Health Care Spin-Off
3M’s health care company spin-off is expected to be launched in the first half of 2024 under the name Solventum.

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

El Salvador Sets Up New Regulatory Body To Oversee Medicines & Devices
El Salvador has approved a new law that will establish a new regulatory body responsible for authorizing medicines and setting prices.

News We’re Watching: Boston Scientific Closes Relievant, Medtronic's PFA Earns CE Mark, And More
Medtech Insight's News We're Watching highlights medtech industry news developments you may have missed over the last few weeks.

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

Digital Health Roundup: Black Friday Hits – Digital Twins, Biowearables, Robotics, Cardiology
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.

Akili Awaits FDA Feedback On Data Needs For OTC Marketing Of ADHD Digital Therapeutic
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.

Notified Body Training Session Highlights Need For More Support For SMEs
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.

Policy Misalignment Is Harming AI Development, Experts Say
Experts lamented the lack of consensus standards for AI medical devices, which they said could pose harm to innovators.
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