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It’s Been Over 1100 Days Since MCIT, Still No TCET In Sight
AdvaMed’s new online clock documents the time since CMS promised to replace MCIT, a program guaranteeing coverage for FDA-cleared breakthrough devices.
EU Regulatory Experts Support Notified Bodies, But Argue For Greater Consistency
Notified bodies have been a pivotal part of the EU medtech regulatory system since it was first launched in the 1990s. Where might they fit within a new medtech regulatory governance structure? Panelists on a recent vodcast grappled with the question.
Ekso's Exoskeleton Receives Medicare Coverage, Paves Way To Faster Rehabilitation
Ekso Bionics’ exoskeleton received a final payment determination from the Centers for Medicare and Medicaid Services, paving the way to faster rehabilitation for more patients.
Mini-Slings Are Comparable To Traditional Ones To Treat Incontinence, FDA Says
The US FDA continues to provide updates on the safety and efficacy of surgical mesh sling procedures, a common surgery to correct stress urinary incontinence.
Spotlight On Conferences
‘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.
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Medtech Insight Podcasts
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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
More Heartmate Troubles For Abbott. Latest Recall Includes 14 Deaths
Abbott initiated a recall in February of thousands of Heartmate devices due to a system obstruction that can result in serious health outcomes, including death. The FDA has now designated the recall as class I.
Patent Office Issues Proposed Rule For Rarely Successful Director Review Requests
The rulemaking is supposed to formalize the Patent Trial and Appeal Board process, which has been in an interim status since a Supreme Court decision, giving manufacturers more ability to request oversight of the decisions.
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.
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.
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.
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.
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.
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.
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.
More Heartmate Troubles For Abbott. Latest Recall Includes 14 Deaths
Abbott initiated a recall in February of thousands of Heartmate devices due to a system obstruction that can result in serious health outcomes, including death. The FDA has now designated the recall as class I.
Patent Office Issues Proposed Rule For Rarely Successful Director Review Requests
The rulemaking is supposed to formalize the Patent Trial and Appeal Board process, which has been in an interim status since a Supreme Court decision, giving manufacturers more ability to request oversight of the decisions.
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.
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.
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.
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.
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.
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.
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