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Featured Stories

MedTech Europe Calls For Swift Answers In Areas Where AI Act Threatens MedTech

With the EU AI Act close to being finally adopted, industry is now calling for guidance and clarification to prevent the new legal text complicating the regulation of medical devices and diagnostics and putting obstacles in the way of patient access to innovation.

Europe EU Medical Device

Exec Chat: A Conversation With The Program Manager Of The World Health Data Hub

WHO Health Data Hub Program Manager Jean-François Saint-Pierre spoke to Medtech Insight at HIMSS24 about creating and maintaining the health data set.

Digital Health International Medical Device

As A Young Woman Marissa Fayer ‘Fell’ Into Medtech. Now, As An Industry Leader, She’s Focused On Leveling The Field

Marissa Fayer is dedicated to advancing women’s health. The founder and CEO of HERhealthEQ, a global nonprofit focused on women’s health equity in emerging and developing countries, Fayer is also the CEO of DeepLook Medical. As part of our focus on women’s health in honor of Women’s History Month, Fayer spoke to Medtech Insight about the importance of having more women in all sectors of medtech, both for the benefit of industry as well as women patients.

Women's Health Policy Medical Device

News We're Watching: LDT Survey Finds Concern, Abbott Recall, New Q-Sub Guidance

This week, the US Congress advanced legislation that would support better cardiac emergency preparedness in schools; the former CEO of device company Stimwave was convicted on two counts of fraud; and the FDA issued a draft guidance document on the thermal affects of medical devices.

Regulation Recalls Enforcement

Spotlight On AI Regulation

Medtech Insight Podcasts


This Episode:

Cardio Conversations: ‘Much More Than Just A Patch.’ iRhythm CEO Blackford Talks AI Arrhythmia Diagnostics
 

Listen to Medtech Insight podcasts for our perspectives on regulation, policy, quality, R&D and key commercial topics.

More Podcasts

Global Device Regulation

Artificial Intelligence: US FDA Plans Guidances On Algorithm Bias, Product Development

Cross-center AI strategy features collaboration between drug, biologic, device and combination product staff to ensure regulatory predictability. ‘Assurance labs’ offering independent valuation of models should be available by year-end as part of FDA’s involvement with Coalition for Health AI.

Artificial Intelligence FDA

EU Institutions Reach Provisional Agreement On Proposed Health Data Regulation Amendments

Key changes have been agreed to the original European Commission text which would allow patients to opt out or restrict sharing of their information.

EU Europe

EPA Final Rule Limits Use Of Ethylene Oxide

The rule, which requires most device sterilization plants to track and report their EtO emissions, will go into effect in two years for the smallest plants and three years for the largest.

Policy Regulation

New UAE Regulator Calls On Drug and Device Companies To Help Shape Mandate

Facilitating and strengthening R&D, intellectual property rights protection and drug safety are among the goals of the soon-to-be-launched Emirates Drug Establishment. Despite the name, the entity is also responsible for device regulation.

United Arab Emirates Regulation
Digital Health

Cybersecurity Guidance Update Lays Out ‘Cyber Device’ Rules

Draft guidance from the US Food and Drug Administration details what the agency wants to see to demonstrate cybersecurity in connected devices during premarket submissions. 

Cybersecurity Guidance Documents

Day 2: IMDRF Guidance Documents In The Works

Discussions during the second day of the 25th session of the International Medical Device Regulators Forum focused on the establishment of working groups to iron out a plethora of issues for international harmonization.

FDA International

In Five Years, People Will Navigate Their Health Care With An AI Advisor – Verily’s Andrew Trister

The digital “agent” on the horizon will draw on users’ entire health record, data from wearables and other sources to steer them in making health decisions. In this second part of a two-part series, Andrew Trister, chief scientific officer and chief medical officer at Verily, discusses his vision for the future and current obstacles.

Digital Health Artificial Intelligence

Verily’s Andrew Trister On Uniting The Pieces To Create Personalized Health, Equity

Andrew Trister, Verily’s chief medical and scientific officer sat down with Medtech Insight during the recent ViVE conference to talk about how Verily is leveraging AI to address public health issues and global health inequities and the new web-based version of the Onduo platform, the use of GLP-1s to combat chronic diseases, and more. This is the first part of a two-part series on Verily. 

Exec Chats Artificial Intelligence
See All
Interviews

‘Why Am I Not Seeing More Women In The Hiring Mix?’ MedExec Women Founder Says It’s Time For Change

Maria Shepherd, co-founder of MedExec Women, a nonprofit that seeks to empower executive leaders in medtech, is preparing to host the group’s fifth annual conference in Boston, which is expected to draw 200 attendees. Shepherd spent more than two decades in the medical device industry before starting consulting firm Medi-Vantage. She talks to Medtech Insight about her own career path, how the industry is changing, and the importance of “grooming” the next generation of young medtech leaders.

Women's Health Commercial Strategies

Leading The Way From A Singular Position - An IWD Perspective

Anne Osdoit has learned how to transform what would be challenges in her career into sources of inspiration. With this vital skill, she has not only led her company, Moon Surgical, to success, but also aided Sofinnova, where she serves as partner, in its investment strategy.

Medical Device Commercial

Exec Chat: A Conversation With The Program Manager Of The World Health Data Hub

WHO Health Data Hub Program Manager Jean-François Saint-Pierre spoke to Medtech Insight at HIMSS24 about creating and maintaining the health data set.

Digital Health International

As A Young Woman Marissa Fayer ‘Fell’ Into Medtech. Now, As An Industry Leader, She’s Focused On Leveling The Field

Marissa Fayer is dedicated to advancing women’s health. The founder and CEO of HERhealthEQ, a global nonprofit focused on women’s health equity in emerging and developing countries, Fayer is also the CEO of DeepLook Medical. As part of our focus on women’s health in honor of Women’s History Month, Fayer spoke to Medtech Insight about the importance of having more women in all sectors of medtech, both for the benefit of industry as well as women patients.

Women's Health Policy
Podcasts

Medtech Connect Episode 13: Augmented Reality In Surgery

In this episode, US regulatory reporter Hannah Daniel speaks to Ocutrx CEO Michael Freeman about augmented reality in medical products and their not-so-unique regulatory requirements. 

Digital Health Regulation

Cardio Conversations: ‘Much More Than Just A Patch,’ iRhythm CEO Blackford Talks AI Arrhythmia Diagnostics

iRhythm CEO Quentin Blackford returned to Medtech Insight’s Cardio Conversations podcast to talk about the launch of his company’s new Zio monitor patch supported by a sophisticated neural network. He also addressed the company’s plans to improve its position in the mobile cardiac telemetry market, the impact of pulsed field ablation on the cardiac monitoring business, and more.

Cardio Conversations Cardiology

Diagnostics CEOs In Triplicate Weigh In On Upcoming Hurdles

Tune in to this one-off podcast feature discussing the state-of-play in the diagnostics sector, with guests from ImmunExpress, Lucid Diagnostics and ChromaCode. 

Blood & Coagulation Disorders Diagnostics

Medtech Connect Episode 12: Apple’s Patent Infringement Cases

Medtech Insight regulatory reporter Hannah Daniel speaks to Sanjay Voleti, AliveCor’s chief business officer, about his company’s patent infringement case against Apple and what it’s like to take on a tech giant over intellectual property.

Intellectual Property Legal Issues
See All
Recent Stories

Artificial Intelligence: US FDA Plans Guidances On Algorithm Bias, Product Development

Cross-center AI strategy features collaboration between drug, biologic, device and combination product staff to ensure regulatory predictability. ‘Assurance labs’ offering independent valuation of models should be available by year-end as part of FDA’s involvement with Coalition for Health AI.

‘Why Am I Not Seeing More Women In The Hiring Mix?’ MedExec Women Founder Says It’s Time For Change

Maria Shepherd, co-founder of MedExec Women, a nonprofit that seeks to empower executive leaders in medtech, is preparing to host the group’s fifth annual conference in Boston, which is expected to draw 200 attendees. Shepherd spent more than two decades in the medical device industry before starting consulting firm Medi-Vantage. She talks to Medtech Insight about her own career path, how the industry is changing, and the importance of “grooming” the next generation of young medtech leaders.

EU Institutions Reach Provisional Agreement On Proposed Health Data Regulation Amendments

Key changes have been agreed to the original European Commission text which would allow patients to opt out or restrict sharing of their information.

Leading The Way From A Singular Position - An IWD Perspective

Anne Osdoit has learned how to transform what would be challenges in her career into sources of inspiration. With this vital skill, she has not only led her company, Moon Surgical, to success, but also aided Sofinnova, where she serves as partner, in its investment strategy.

EPA Final Rule Limits Use Of Ethylene Oxide

The rule, which requires most device sterilization plants to track and report their EtO emissions, will go into effect in two years for the smallest plants and three years for the largest.

New UAE Regulator Calls On Drug and Device Companies To Help Shape Mandate

Facilitating and strengthening R&D, intellectual property rights protection and drug safety are among the goals of the soon-to-be-launched Emirates Drug Establishment. Despite the name, the entity is also responsible for device regulation.

European Parliament Adopts AI Act, But Success Hangs On The AI Office

The European Parliament adopted the EU AI Act in plenary on 13 March. Experts say the wider success of the EU’s approach to AI is now in the hands of the EU AI Office.

40% Plus Growth In Notified Body Certificates Issued Under EU Medtech Regulations

After years of concern over notified body ability manage the volume of conformity assessment applications from medtech manufacturers, there is evidence that capacity has increased significantly, and this is showing results.

Cybersecurity Guidance Update Lays Out ‘Cyber Device’ Rules

Draft guidance from the US Food and Drug Administration details what the agency wants to see to demonstrate cybersecurity in connected devices during premarket submissions. 

Sex-Based Diversity In Clinical Trials Can And Will Improve – An IWD Perspective

As a three-time cancer survivor and someone who has participated in a device trial, Alicia Staley, Medidata’s VP of patient engagement, is no stranger to innovative treatments. She spoke to Medtech Insight about how both the gender and socioeconomic diversity of trial participants could be improved.

Day 2: IMDRF Guidance Documents In The Works

Discussions during the second day of the 25th session of the International Medical Device Regulators Forum focused on the establishment of working groups to iron out a plethora of issues for international harmonization.

Healthtech Responds To Providers’ Productivity, Workflow And Sustainability Concerns

Healthtech innovators are being asked by users and clinicians how technology solutions can increase health system efficiency and respond to concerns over staff shortages. Royal Philips’ Bert van Meurs fielded these questions at ECR 2024.

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