Featured Stories
Why Vital EU Guidance For Clinical Investigation Plans Is So Challenging To Read
Errors or omissions are commonplace when sponsors write their clinical investigation plans. Good signposting is urgently needed. Industry expert Maria Donawa gave some useful tips in how to best read the latest EU clinical trials guidance.
Glitch Prompts Smiths To Recall Emergency Ventilators
After reports of eight serious injuries, Smiths Medical recalled nearly 3,000 ventilators used during emergency transport.
UK Body Proposes Contract To Expedite Clinical Trials
The ownership of all study data would be granted to the non-commercial sponsor, says one of the many provisions proposed in the model investigator-initiated study agreement that the Health Research Authority has released for consultation.
Johnson & Johnson Poised To Lead Multiple Cardiovascular Markets With Shockwave Medical Acquisition
J&J’s acquisition of IVL device maker Shockwave Medical for $13.1bn sets J&J’s medtech arm solidly in a leadership position in multiple cardiovascular markets.
Spotlight On Conferences
A More Cautious Approach To AI, And Other Policy And Regulation Trends From HIMSS 24
Risk-based AI regulations and data modernization are just a few of the top policy priorities from thought leaders attending the largest health care technology professional gathering in the world.
Creating Standards For Responsible AI In Health Care
Imagining Cybersecurity As An Ecosystem: From Regulations To Resiliency
Canary Speech’s Voice AI Can Help Detect Alzheimer’s With 40-Second Conversation
In Five Years, People Will Navigate Their Health Care With An AI Advisor – Verily’s Andrew Trister
Latest News
Medtech Insight Podcasts
This Episode:
Cardio Conversations: ‘Much More Than Just A Patch.’ iRhythm CEO Blackford Talks AI Arrhythmia DiagnosticsListen to Medtech Insight podcasts for our perspectives on regulation, policy, quality, R&D and key commercial topics.
More PodcastsData Trackers
Global Device Regulation
Abbott Eagerly Awaits Damages Won From DexCom Patent Suit
Abbott’s trial win for patent infringement by DexCom’s CGM systems still doesn’t have information on damages awarded due a hung jury.
FDA Designates A Pair Of Catheter Recalls Class I
The US FDA has labelled a recall of arterial catheterization kits from Arrow International class I and gave the same high-risk designation to a separate recall of neurovascular catheters from Johnson & Johnson company Medos International Sàrl.
First Danish Notified Body Named Under EU's Medical Device Regulation
The EU now has a total of 45 notified bodies under the MDR.
Warning Letters– March 2024
The US Food and Drug Administration released seven warning letters in March 2024, of which three were related to a recent crackdown on China-made syringes. Other letters recounted troubles at Exactech, Fresenius and ReNovo, as well as clinical trial violations from Nobles Medical Technology.
Digital Health
News We're Watching: Abbott, Click, Otsuka, Prenosis Win FDA Approval; EU Health Data Space Proposal, And More
This week, Abbott, Click and Otsuka, Prenosis won the FDA nod respectively for an in vitro diagnostic to evaluate patients for concussion, the first prescription digital therapeutic to treat major depressive disorder and a software to predict sepsis. Also on the regulatory front, the FDA will now take 513(g)s forms via its eSTAR framework. In Europe, the debate of what personal information can be shared continues.
German IVDs At The Turning Point: Digital And AI Show Future Market Direction
Europe’s largest national in vitro diagnostics market is evolving post-COVID, under the effects of new digital laws, artificial intelligence-enabled devices, apps on prescription and the rising popularity of continuous glucose monitors. The VDGH industry association’s latest survey indicates a changing market landscape for IVDs in 2024.
Medtech Connect 14: Live From HIMSS
In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to industry professionals at the Healthcare Information and Management Systems Society (HIMSS) 2024 conference about what they enjoy about the annual gathering and what excites them for the future.
AI Tool Could Be ‘Groundbreaking’ In Early Detection Of Heart Failure
The US FDA has cleared an AI tool from Eko Health that could help doctors detect heart failure during routine physical exams. Developed with the Mayo Clinic, the tool can pick up a key early indicator for heart failure, which can often go undiagnosed.
Interviews
Why Vital EU Guidance For Clinical Investigation Plans Is So Challenging To Read
Errors or omissions are commonplace when sponsors write their clinical investigation plans. Good signposting is urgently needed. Industry expert Maria Donawa gave some useful tips in how to best read the latest EU clinical trials guidance.
Medtech Connect 14: Live From HIMSS
In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to industry professionals at the Healthcare Information and Management Systems Society (HIMSS) 2024 conference about what they enjoy about the annual gathering and what excites them for the future.
Jasmine Balloch: Inspiring And Achieving Success
Jasmine Balloch, chief of staff at generative AI medtech startup Tortus, reflects on opportunities for women to succeed and repackage success, providing advice on how to succeed as a woman in medtech.
Imagining Cybersecurity As An Ecosystem: From Regulations To Resiliency
Medical device cybersecurity is a part of a larger ecosystem that should not—and cannot—be ignored.
Podcasts
Medtech Connect 14: Live From HIMSS
In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to industry professionals at the Healthcare Information and Management Systems Society (HIMSS) 2024 conference about what they enjoy about the annual gathering and what excites them for the future.
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.
Recent Stories
Abbott Eagerly Awaits Damages Won From DexCom Patent Suit
Abbott’s trial win for patent infringement by DexCom’s CGM systems still doesn’t have information on damages awarded due a hung jury.
FDA Designates A Pair Of Catheter Recalls Class I
The US FDA has labelled a recall of arterial catheterization kits from Arrow International class I and gave the same high-risk designation to a separate recall of neurovascular catheters from Johnson & Johnson company Medos International Sàrl.
First Danish Notified Body Named Under EU's Medical Device Regulation
The EU now has a total of 45 notified bodies under the MDR.
Warning Letters– March 2024
The US Food and Drug Administration released seven warning letters in March 2024, of which three were related to a recent crackdown on China-made syringes. Other letters recounted troubles at Exactech, Fresenius and ReNovo, as well as clinical trial violations from Nobles Medical Technology.
News We're Watching: Abbott, Click, Otsuka, Prenosis Win FDA Approval; EU Health Data Space Proposal, And More
This week, Abbott, Click and Otsuka, Prenosis won the FDA nod respectively for an in vitro diagnostic to evaluate patients for concussion, the first prescription digital therapeutic to treat major depressive disorder and a software to predict sepsis. Also on the regulatory front, the FDA will now take 513(g)s forms via its eSTAR framework. In Europe, the debate of what personal information can be shared continues.
Few High-Risk Devices Subject To EU’s Greatest Level Of Scrutiny
Just four devices were subject to a scientific opinion from an expert panel in the second year of reviews, compared with six in the previous year.
German IVDs At The Turning Point: Digital And AI Show Future Market Direction
Europe’s largest national in vitro diagnostics market is evolving post-COVID, under the effects of new digital laws, artificial intelligence-enabled devices, apps on prescription and the rising popularity of continuous glucose monitors. The VDGH industry association’s latest survey indicates a changing market landscape for IVDs in 2024.
Australia Cuts Regulatory Burden Of Product Recalls
The Therapeutic Goods Administration says it has made a series of improvements in areas such as the recall and stakeholder communication process, reporting requirements, and the agency’s guidance materials.
Report Says VHA Needs Better Implant Tracking
A new report from the US Government Accountability Office found that the Veterans Health Administration does not track implanted devices at an individual-patient level, which could make it harder to communicate important safety information in the event of a recall.
Medtech Connect 14: Live From HIMSS
In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to industry professionals at the Healthcare Information and Management Systems Society (HIMSS) 2024 conference about what they enjoy about the annual gathering and what excites them for the future.
Jasmine Balloch: Inspiring And Achieving Success
Jasmine Balloch, chief of staff at generative AI medtech startup Tortus, reflects on opportunities for women to succeed and repackage success, providing advice on how to succeed as a woman in medtech.
Fresh Opportunity For Free Scientific Advice For High-Risk Devices From EU Expert Panels
The EMA is extending the pilot phase of the EU’s scientific advice program and inviting a third round of applications by mid-2024.
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