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Featured Stories

News We’re Watching: Lung Preservation System Goes National, De Novo For MMI, Brazil’s ANVISA To Recognize Overseas Approvals

This week, Paragonix announced that its BAROguard lung preservation system is now available throughout the US; Brazil planned to leverage some foreign device approvals; Medical Microinstruments’ Symani Surgical System won de novo clearance; and the FDA updated its safety warnings for Essure and certain plastic syringes.

Regulation Commercial Approvals

First Public Discussion On How EU Medtech Regulatory Governance Structure May Evolve

Does the EU need a medtech agency for the first time in its history? Nothing can or should be decided too quickly but five high-profile experts broadly agreed that change is now critical.

Europe EU Compliance

Roche Wins FDA Breakthrough Device Designation For Alzheimer’s Test

Roche announced on 11 April it received FDA breakthrough device designation for a blood test used for early detection of Alzheimer’s disease.

Approvals FDA Commercial

Illumina Appoints Ankur Dhingra CFO

Ankur Dhingra has replaced Joydeep Goswami as Illumina’s chief financial officer after Goswami spent just 14 months on the job. The San Diego-based sequencing and array tech company also appointed Jakob Wedel as chief of strategy and corporate development officer.

Executive Changes Commercial Leadership

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

NAM’S Health Care AI Development Code Of Conduct Addresses Gaps In Current Principles

The National Academy of Medicine developed a code of conduct for health care AI development, as well as commitments for code implementation. 

Artificial Intelligence Regulation

Orthobond, Onkos Surgical Receive FDA De Novo Approval For Antibacterial Technology Used In Medical Devices

Technology partners, Orthobond and Onkos Surgical, announced they received FDA de novo approval for their respective technologies to actively kill bacteria that could contaminate medical devices.

Approvals Commercial

FDA Asked To Withdraw Approval Of Test Evaluating Opioid Addiction Risk

Dozens of researchers signed a letter condemning the AvertD test from SOLVD, which looks for genes that may contribute to a propensity toward opioid addiction. But the FDA and the manufacturer both say the test is effective.

Behavioral Health Approvals

‘Biggest Transformation In The History Of Medicine’: Oncologist And Cardiologist Talk AI-Enabled Health Care

At the recent Precision Med Tri-Con conference, health care leaders and AI enthusiasts Eric Topol and Doug Flora discussed how AI integration will change the way doctors practice medicine and patients receive care.

Artificial Intelligence Personalized Medicine
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. 

News We're Watching Approvals

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.

Germany Policy

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.

Medtech Connect Artificial Intelligence

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.

FDA Artificial Intelligence
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Interviews

First Public Discussion On How EU Medtech Regulatory Governance Structure May Evolve

Does the EU need a medtech agency for the first time in its history? Nothing can or should be decided too quickly but five high-profile experts broadly agreed that change is now critical.

Europe EU

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.

EU Europe

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.

Medtech Connect Artificial Intelligence

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.

Europe EU
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.

Medtech Connect Artificial Intelligence

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
See All
Recent Stories

NAM’S Health Care AI Development Code Of Conduct Addresses Gaps In Current Principles

The National Academy of Medicine developed a code of conduct for health care AI development, as well as commitments for code implementation. 

Orthobond, Onkos Surgical Receive FDA De Novo Approval For Antibacterial Technology Used In Medical Devices

Technology partners, Orthobond and Onkos Surgical, announced they received FDA de novo approval for their respective technologies to actively kill bacteria that could contaminate medical devices.

FDA Asked To Withdraw Approval Of Test Evaluating Opioid Addiction Risk

Dozens of researchers signed a letter condemning the AvertD test from SOLVD, which looks for genes that may contribute to a propensity toward opioid addiction. But the FDA and the manufacturer both say the test is effective.

‘Biggest Transformation In The History Of Medicine’: Oncologist And Cardiologist Talk AI-Enabled Health Care

At the recent Precision Med Tri-Con conference, health care leaders and AI enthusiasts Eric Topol and Doug Flora discussed how AI integration will change the way doctors practice medicine and patients receive care.

Consent Decree Against Philips Entered In Federal Court, Outlines ‘Roadmap’ For Compliance

A consent decree agreed to in January between Royal Philips and the US government is now official. The decree stems from a recall in 2021 of millions of the company’s sleep therapy and breathing devices due to risks posed by the sound abatement foam inside the machines.

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.

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.

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.

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.

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