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Featured Stories

Report Finds Digital Diabetes Tools Deliver No ‘Meaningful Clinical Benefits'

A new report from health economics group the Peterson Health Technology Institute found that apps to help patients manage their blood sugar levels delivered few of the promised benefits. However, a digital therapeutics industry association says PHTI’s research cast too narrow a net. 

Digital Health Cost Effectiveness Research & Development

DTx And Drug Deal Sees Closed Loop Medicine And Teva Team Up On Precision Care

Medicines are still typically prescribed based on average effects in a population and rarely dose-optimized for the individual, says Closed Loop Medicine. The company sees a new strategic partnership with Teva UK as another step in advancing personalized medicine.

Commercial Digital Health Personalized Medicine

FDA Takes Another Swing At Banning Electrical Shock Devices

The US FDA wants to ban devices that use an electrical shock to stop aggressive behavior. The agency attempted to ban the devices in 2020 but failed after it was challenged in court.

FDA Enforcement Behavioral Health

Creating Standards For Responsible AI In Health Care

Medtech Insight spoke to Brian Anderson about creating standards for responsible AI and the policy developments he’s looking forward to in 2024. 

Artificial Intelligence Regulation Policy

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.

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Global Device Regulation

EU Regulatory Roundup, March 2024: Busy Agenda In Broad Range Of Key Areas

March was an important month for EU medtech regulation with an interesting spread of news relating to the Medical Device and IVD Regulations, the Batteries Regulation, the Artificial Intelligence Act and more.

Europe EU

EU’s Revised Phthalates Guideline Features New Annexes Focused On Alternatives

The effects of phthalates, plasticizers used in many medical devices, on the human endocrine system, have long been debated. But how safe are the alternatives? Updated guidelines give more insight.

EU Europe

Congress Revives Talks On LDTs With Clock Ticking On FDA Rule

During a recent hearing of the US House Energy and Commerce Health Subcommittee, lawmakers discussed the best approach to regulating laboratory developed tests (LDTs) with a panel of experts representing clinical labs. At issue was the FDA’s proposed rule that places LDTs under the same regulatory purview as other in vitro diagnostics, which would require medical facilities to receive agency approval for the LDTs they develop in their own labs.

FDA In Vitro Diagnostics

Non-Medical Brain Stimulation Devices: Could They Be Down-Classified Again In the EU?

Six types of products that do not have an intended medical purpose fall under the scope of the Medical Device Regulation. Understanding their risks is complex and subject to regular re-examination by the European Commission. 

EU Europe
Digital Health

Menopause Research To Benefit From White House Initiative To Bolster Women’s Health

Women’s health leaders in the menopause space have high hopes that President Biden’s executive order will provide dollars for more research on how hormone therapy can prevent disease and draw attention to the need for provider education on menopausal symptoms.

Women's Health Digital Health

J&J MedTech Partners With Nvidia To Expand AI In Surgery

J&J MedTech joined forces with Nvidia to advance the integration of AI in surgery, including in devices, and allow for real-time data analysis to help surgeons with decision-making.

Artificial Intelligence Business Strategies

Collecting Sensitive Data With AI Chatbots

Medtech Insight spoke to QliqSOFT executive Bobbi Weber about the advantages of collecting patient data though chatbots, and how the technology can make conversations at the doctor’s office a little more manageable. 

Digital Health Commercial

BD’s CTO Beth McCombs Discusses Key Initiatives – AI/Gen AI; DE&I Strategy; Succession Planning

BD CTO Beth McCombs discusses her role in driving innovation, including the integration of AI and generative AI to create efficiencies, and passion for creating a culture of inclusion, diversity and equity.

Women's Health Artificial Intelligence
See All
Interviews

Creating Standards For Responsible AI In Health Care

Medtech Insight spoke to Brian Anderson about creating standards for responsible AI and the policy developments he’s looking forward to in 2024. 

Artificial Intelligence Regulation

Collecting Sensitive Data With AI Chatbots

Medtech Insight spoke to QliqSOFT executive Bobbi Weber about the advantages of collecting patient data though chatbots, and how the technology can make conversations at the doctor’s office a little more manageable. 

Digital Health Commercial

Daniela Delledonne: ‘Persistence Pays Off’

“We have the power to drive innovation, improve patient outcomes, and shape the future of healthcare, as women in medtech,” Daniela Delledonne, vice-president and general manager at BD Biosciences, told Medtech Insight. We spoke to Delledonne about her experiences of the medtech industry in honor of International Woman’s Day and Women’s History Month.

EU Europe

BD’s CTO Beth McCombs Discusses Key Initiatives – AI/Gen AI; DE&I Strategy; Succession Planning

BD CTO Beth McCombs discusses her role in driving innovation, including the integration of AI and generative AI to create efficiencies, and passion for creating a culture of inclusion, diversity and equity.

Women's Health Artificial Intelligence
Podcasts

Digital Health Roundup: Impact Of EU’s AI Act On Device Makers; Verily's Andrew Trister’s Vision For Personal AI Agent

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights her interview with Verily’s CMO and CSO, Andrew Trister at ViVE on leveraging AI for precision health and a DHIS West conference panel discussion on use cases of generative AI. Elizabeth Orr discusses the impact on the newly adopted EU AI Act on device makers and concerns raised by industry members.

Digital Health Roundup Artificial Intelligence

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
See All
Recent Stories

Menopause Research To Benefit From White House Initiative To Bolster Women’s Health

Women’s health leaders in the menopause space have high hopes that President Biden’s executive order will provide dollars for more research on how hormone therapy can prevent disease and draw attention to the need for provider education on menopausal symptoms.

EU Regulatory Roundup, March 2024: Busy Agenda In Broad Range Of Key Areas

March was an important month for EU medtech regulation with an interesting spread of news relating to the Medical Device and IVD Regulations, the Batteries Regulation, the Artificial Intelligence Act and more.

EU’s Revised Phthalates Guideline Features New Annexes Focused On Alternatives

The effects of phthalates, plasticizers used in many medical devices, on the human endocrine system, have long been debated. But how safe are the alternatives? Updated guidelines give more insight.

J&J Refines Direction For Ottava

Delays have plagued J&J's soft tissue surgical robot. However, the company has now solidified at least its near-term plan and hopes to commence trials later this year.

Congress Revives Talks On LDTs With Clock Ticking On FDA Rule

During a recent hearing of the US House Energy and Commerce Health Subcommittee, lawmakers discussed the best approach to regulating laboratory developed tests (LDTs) with a panel of experts representing clinical labs. At issue was the FDA’s proposed rule that places LDTs under the same regulatory purview as other in vitro diagnostics, which would require medical facilities to receive agency approval for the LDTs they develop in their own labs.

Non-Medical Brain Stimulation Devices: Could They Be Down-Classified Again In the EU?

Six types of products that do not have an intended medical purpose fall under the scope of the Medical Device Regulation. Understanding their risks is complex and subject to regular re-examination by the European Commission. 

News We’re Watching: Widespread Plastic Syringe Issues, Call For TAP Pilot Comments, AdvaMed/FDA Conference, Warning Letter Roundups

This week, the US FDA issued an update on its safety warning for plastic syringes made in China; AdvaMed announced a medical device and diagnostics statistical conference in collaboration with the agency; the FDA is looking for comments on its TAP Pilot and published two warning letters for high-profile recalls. 

J&J MedTech Partners With Nvidia To Expand AI In Surgery

J&J MedTech joined forces with Nvidia to advance the integration of AI in surgery, including in devices, and allow for real-time data analysis to help surgeons with decision-making.

Nearly 50 New And Revised EU MDR and IVDR Guidances In The Pipeline

Want to know if a much-needed official EU medtech regulatory document is in the pipeline? An updated list of guidance and other documents in the making is now available.

Collecting Sensitive Data With AI Chatbots

Medtech Insight spoke to QliqSOFT executive Bobbi Weber about the advantages of collecting patient data though chatbots, and how the technology can make conversations at the doctor’s office a little more manageable. 

FDA Leader Looks To International Effort On Pediatric Device Development

Collaboration with Japan and Europe could help ease the development path for pediatric devices, cardiovascular device office director Bram Zuckerman said at a recent conference. Zuckerman also spoke on other cardiac device priorities at the FDA.

49 Deaths Linked To Recalled Abiomed Heart Pumps

The US FDA reports 49 deaths associated with a December recall of Abiomed pumps that are used to support the heart during high-risk cardiac surgery.

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