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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.
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.
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.
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.
Spotlight On AI 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.
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Biden Administration Is Setting An Example For Safe AI Use In Federal Organizations
A new memorandum by the Director of the Office of Management and Budget initiated a government-wide policy that will appoint AI officers to all agencies to address risks for AI use and serve as an example for greater AI adoption.
Pair Of Deaths Linked To Recalled Vyaire Medical Respiratory Devices
The US FDA has labelled a recall of more than 6 million Airlife respiratory support devices class I. The recall covers devices manufactured in 2017 or earlier that can fail to provide adequate ventilation.
EU Must Crack Down Harder On Fake Medical Devices, Says Innovator
Counterfeit copies of LifeVac Europe’s anti-choking devices have been registered on the EU’s EUDAMED database and continue to be sold on third-party platforms. Medtech Insight asked director of sales and marketing Matthew Banagan how the company deals with fake devices and what the authorities must do.
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.
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.
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.
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.
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.
EU Must Crack Down Harder On Fake Medical Devices, Says Innovator
Counterfeit copies of LifeVac Europe’s anti-choking devices have been registered on the EU’s EUDAMED database and continue to be sold on third-party platforms. Medtech Insight asked director of sales and marketing Matthew Banagan how the company deals with fake devices and what the authorities must do.
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.
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.
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.
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.
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.
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.
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.
Biden Administration Is Setting An Example For Safe AI Use In Federal Organizations
A new memorandum by the Director of the Office of Management and Budget initiated a government-wide policy that will appoint AI officers to all agencies to address risks for AI use and serve as an example for greater AI adoption.
Pair Of Deaths Linked To Recalled Vyaire Medical Respiratory Devices
The US FDA has labelled a recall of more than 6 million Airlife respiratory support devices class I. The recall covers devices manufactured in 2017 or earlier that can fail to provide adequate ventilation.
EU Must Crack Down Harder On Fake Medical Devices, Says Innovator
Counterfeit copies of LifeVac Europe’s anti-choking devices have been registered on the EU’s EUDAMED database and continue to be sold on third-party platforms. Medtech Insight asked director of sales and marketing Matthew Banagan how the company deals with fake devices and what the authorities must do.
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.
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