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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.

EU North America Canada

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.

Artificial Intelligence Diabetic Care Diagnostics

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.”

Artificial Intelligence Government Payers Innovation

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.

FDA Standards Policy

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.

Israel Artificial Intelligence

Medtech Insight Podcasts


This Episode:

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

Listen 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.

Europe EU

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.

Europe EU

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.

Cybersecurity Regulation

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.

El Salvador Policy
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.

Digital Health Approvals

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.

Digital Health FDA

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.

Artificial Intelligence Policy

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.

Exec Chats Artificial Intelligence
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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.

Artificial Intelligence Diabetic Care

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.

Exec Chats Artificial Intelligence

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.

Digital Health Platform Technologies

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.

Digital Health Behavioral Health
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 Approvals

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.

Artificial Intelligence Behavioral Health

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.

Policy Real-World Evidence

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.

Medicare Regulation
See All
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.

Europe EU

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.

Europe EU

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.

Cybersecurity Regulation

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. 

Commercial Companies

Execs On The Move: October 2023

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

Executive Changes Commercial

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.

El Salvador Policy

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.

News We're Watching Clinical Trials

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.

M & A Orthopedics

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 Approvals

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.

Digital Health FDA

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.

Europe EU

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.

Artificial Intelligence Policy
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