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Featured Stories

Philips Portfolio Includes ‘No Single Product That Does Not Use A Type Of AI,’ Says CEO And AI Thought Leader Roy Jakobs

Philips CEO Roy Jakobs talks to Medtech Insight about the medtech firm’s decade-long history of embedding AI into its products and what he expects from the newly released draft framework by the National Academy of Medicine, which he helped develop as co-chair of the Steering Committee.

Artificial Intelligence Business Strategies FDA

Interview: Theradaptive To Enter Clinical Trial For Spinal Fusion Implant

Theradaptive, which makes a device-biologic combination product to help speed bone healing, recently got authorization to start human trials from the US FDA. Medtech Insight spoke to CEO Luis Alvarez about the company’s past, present and future.

Regulation Commercial Companies

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. 

Patents Intellectual Property Regulation

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.

FDA Recalls Cardiology

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

Clinical Trial Diversity Requires Sponsors Work With An Assortment Of Patient Advocates, Community Organizations

US FDA oncology officials are concerned that the entities sponsors are consulting in developing and implementing clinical trial diversity plans are not sufficiently diverse themselves and do not represent patients in underserved communities.

Clinical Trials Diversity & Inclusion

Israeli Company Lands De Novo Clearance For Digital Bone Marrow Application

The US FDA has cleared a novel software application to enhance the analysis of bone marrow smears. Using the AI-powered tool, hematopathologists may be able to better diagnose various blood and marrow diseases.

FDA Diagnostics

Medtechs Must Reflect On China Localization Policies As VBP Expands

China continues to roll out volume-based procurement for medical devices and pharma products and companies should plan their strategies accordingly, advises EY Parthenon’s Hua Su.

China Pricing Strategies

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.

Medicare Reimbursement
Digital Health

Behavioral Health Company Two Chairs Secures $72M In Equity And Debt Infusion

Two Chairs, which uses algorithms to match the right therapists with patients, secured $72m in investment to expand its business.

Artificial Intelligence Behavioral Health

Israeli Company Lands De Novo Clearance For Digital Bone Marrow Application

The US FDA has cleared a novel software application to enhance the analysis of bone marrow smears. Using the AI-powered tool, hematopathologists may be able to better diagnose various blood and marrow diseases.

FDA Diagnostics

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

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
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Interviews

Interview: Theradaptive To Enter Clinical Trial For Spinal Fusion Implant

Theradaptive, which makes a device-biologic combination product to help speed bone healing, recently got authorization to start human trials from the US FDA. Medtech Insight spoke to CEO Luis Alvarez about the company’s past, present and future.

Regulation Commercial

Philips Portfolio Includes ‘No Single Product That Does Not Use A Type Of AI,’ Says CEO And AI Thought Leader Roy Jakobs

Philips CEO Roy Jakobs talks to Medtech Insight about the medtech firm’s decade-long history of embedding AI into its products and what he expects from the newly released draft framework by the National Academy of Medicine, which he helped develop as co-chair of the Steering Committee.

Artificial Intelligence Business Strategies

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
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

Behavioral Health Company Two Chairs Secures $72M In Equity And Debt Infusion

Two Chairs, which uses algorithms to match the right therapists with patients, secured $72m in investment to expand its business.

Clinical Trial Diversity Requires Sponsors Work With An Assortment Of Patient Advocates, Community Organizations

US FDA oncology officials are concerned that the entities sponsors are consulting in developing and implementing clinical trial diversity plans are not sufficiently diverse themselves and do not represent patients in underserved communities.

Israeli Company Lands De Novo Clearance For Digital Bone Marrow Application

The US FDA has cleared a novel software application to enhance the analysis of bone marrow smears. Using the AI-powered tool, hematopathologists may be able to better diagnose various blood and marrow diseases.

Medtechs Must Reflect On China Localization Policies As VBP Expands

China continues to roll out volume-based procurement for medical devices and pharma products and companies should plan their strategies accordingly, advises EY Parthenon’s Hua Su.

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.

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.

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.

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.

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.

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