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Cleerly Advances CCTA Digital Pathway To Stop Heart Disease

Using artificial intelligence and coronary computed tomography angiography Cleerly is trying to shift cardiology's focus from symptoms-based interventions to prevention and treatment of the underlying vascular disease.

Artificial Intelligence Cardiovascular Diagnostic Imaging

Digital Health Regulations: A Year In Review

RQM’s Allison Komiyama and Kevin Go summarized up the year’s changes to digital health regulation and outlined what to expect in the coming year.

Digital Health Regulation Guidance Documents

EU Data Act Must Consider ‘Sectoral Peculiarities’ Says Medtech Industry

The European Commission’s proposed Data Act is among a growing pile of horizontal regulations set to impact the medtech industry. But changes should be made to protect trade secrets and other sector-specific nuances, MedTech Europe warns.

Europe EU Digital Health

Swiss Initiative To Monitor Missing Medical Devices To Manage Current Product Crisis

The ongoing availability of many medical devices in Switzerland is threatened even more severely than in the EU. Medtech Insight spoke to two key life science experts to understand why this is and to hear the solutions they are proposing.

Europe EU Switzerland

European Parliament Calls For Risk-Related Extensions Under MDR And IVDR

With the EU’s Employment, Social Policy and Consumer Affairs Council due to discuss solutions to the MDR crisis on 9 December, the European Parliament is calling for risk-related deferrals.

EU Europe Medical Device

European Commission Proposal To Free Up Notified Body Time And Extend Reassessment Deadlines

The EU is in urgent need of more notified bodies to test medtech products under the Medical Device and IVD Regulations. The commission is taking steps to free up everyone’s time.

EU Medical Device In Vitro Diagnostics

Minute Insight: Intel-Penn Tie-Up Proves Federated Approach’s Power

Federated learning has taken another step forward thanks to new research that proves it is better at spotting brain tumors. 

Innovation Artificial Intelligence Platform Technologies

Medtech Monthly Podcast

In This Episode:

Listen to Medtech Insight podcasts for our perspectives on regulation, policy, quality, R&D and key commercial topics. >More Podcasts

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Policy & Regulation Explore this Topic

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It’s A Class I Recall For Baxter’s WatchCare Device

Radiofrequencies from the incontinence-sensing devices may interfere with other medical equipment in a hospital setting. 

Recalls Regulation FDA

CAMD Says ‘Critical Appraisal’ Needed On EU MDR Capacity Bottlenecks

Yet another EU regulatory organization has stressed the need for action to address MDR capacity problems. According to CAMD, underlying factors and causes of the crisis must be identified.

EU Europe Medical Device

Latest From Policy & Regulation

New Warning Label Added To AFX2 Endovascular Graft

The US FDA released updated safety information on Endologix Inc.’s AFX2 Endovascular abdominal aortic aneurysm (AAA) graft system on Tuesday. Previous devices in the product line have been associated with an increased risk of abnormal bleeding.

Regulation Safety

Warning Letter Close-Outs – November 2022

The US FDA released three device-related close-out letters in November, all of which related to premarket conduct.

Warning Letters FDA

Warning Letter Roundup & Recap – November 2022

The US Food and Drug Administration published only one device-related warning letter last month. It went to an Illinois clinical trial site.

Warning Letters Clinical Trials

Global Medtech Guidance Tracker: November 2022

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-eight documents have been posted on the tracker since its last update.

Guidance Documents Regulation

View From German Industry: MDR At The Turning Point

Spectaris’ Marcus Kuhlmann describes Medica as a valued hub to meet member companies and host ecosystem and trade updates for the wider medtech industry. The German industry association’s medtech leader spoke to Medtech Insight during the 2022 event about the top concerns for manufacturers.

Germany EU

What Is Behind China's 'Zero-COVID'? Money-Making Machines And Business Interest Chains

One well-connected individual registered as many as 35 nucleic testing firms within just a few months, all of which are strategically located in the Chinese cities that have seen some of the worst COVID-19 flareups. Meanwhile, regulators have halted the IPOs of 13 companies.

China Coronavirus COVID-19

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

Crucial Council Of EU Debate On Medical Device Regulation Crisis Countdown

The Council of EU’s agenda for the critical upcoming health council meeting confirms position of EU Medical Device Regulation in day’s running, along with other key health issues.

EU Europe

Reclassification Of Active Annex XVI Products Now Official

Certain active products without an intended purpose, where member states had concerns over potential inadequate regulation, now fall under stricter Medical Device Regulation rules.

EU Europe

European Regulatory Roundup, November 2022: EU MDR Situation Now Critical

Damage limitation action is expected imminently to try and stem the flow of medtech products being taken off the EU market. And it cannot come quickly enough as evidence continues to mount of the negative fall-out resulting from the way the EU’s new medical device regulations have been, and are being, implemented.

EU Europe

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Minute Insight: Activ Surgical Wins CE Mark For ActivSight

After winning US FDA clearance in 2021, Activ Surgical now also received the green light to market its visualization module for surgeons in Europe. 

Minute Insights Approvals Europe

Latest From Commercial

Some Essential Cardiac Devices In Short Supply, FDA Warns

The US Food and Drug Administration is alerting health care providers that some cardiac devices from a major supplier are in short supply.

FDA Policy

GE Finalizes Details Of GE HealthCare Spin-Off

Over four years in the making, the deal will spin-off General Electric’s health care business into a separate public company.

Medical Device Commercial

Canon To Launch US-Based Medical Imaging Company In January 2023

Japan-based Canon plans to launch a US-based medical imaging company near Cleveland to strengthen its US presence and competitiveness in the marketplace.

Business Strategies Growth

Minute Insight: GE Healthcare Partners With MediView XR To Create AR Solution For Integrated MR Imaging

GE Healthcare and MediView announced a partnership to co-develop a technology platform that integrates medical imaging into mixed reality solutions.

Minute Insights Digital Health

CMR Signs Deal With J&J To Bring Robots To Europe And South America

CMR Surgical will collaborate with Johnson & Johnson/Ethicon to expand access to its Versius robotic surgery system.

Minute Insights Robotic Surgery

Boston Scientific Makes Half Billion Dollar GI Endosurgery Play

Boston Scientific is greatly increasing its GI endosurgery capabilities with the acquisition of Apollo Endosurgery, a manufacturer of various device for weight loss-related surgeries.

Commercial Companies

Clinical R&D Explore this Topic

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So, You Built A Surgical Robot. How Do You Sell It?

CMR Surgical has grown rapidly since being founded just over eight years ago. However, unlike most other medtech companies, CMR is not selling a ~$30 diagnostic test, or a ~$5,000 pacemaker. It is selling a complex surgical robot, called Versius, with a price tag rumored to be in the seven figures. 

Robotic Surgery Growth Platform Technologies

Latest From Research & Development

Canon To Launch US-Based Medical Imaging Company In January 2023

Japan-based Canon plans to launch a US-based medical imaging company near Cleveland to strengthen its US presence and competitiveness in the marketplace.

Business Strategies Growth

Minute Insight: GE Healthcare Partners With MediView XR To Create AR Solution For Integrated MR Imaging

GE Healthcare and MediView announced a partnership to co-develop a technology platform that integrates medical imaging into mixed reality solutions.

Minute Insights Digital Health

Digital Health Roundup: HLTH2022 Highlights, EU Updates, Diabetes Medtech Monthly

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb provides highlights from the recent HLTH conference in Las Vegas. Reed Miller and Barnaby Pickering offer an overview of the highly competitive diabetes tech market. We also talk about digital health in Germany and Europe.

Digital Health Innovation

Minute Insight: Apple Watch Now Features FDA-Cleared App To Monitor Parkinson’s Disease Symptoms

A newly cleared Apple Watch app will allow people living with Parkinson’s to more easily track tremors, dyskinesia and other symptoms.

Digital Health Neurology

HLTH 2022 Roundup: Mirvie, Grail, Biofourmis, Komodo Health, Babson Diagnostics

This year’s annual HLTH meeting drew more than 9,000 people to Las Vegas from 13-16 November and hundreds of exhibitors. In this first part of a two-part roundup, Medtech Insight highlights interviews with C-suite executives at Mirvie, Grail, Biofourmis, Komodo Health and Babson Diagnostics.

Innovation Digital Health

Minute Insight: Apple Watch Helps Knee-Replacement Patients In Zimmer Biomet-Sponsored Trial

One-year data from a randomized controlled trial showed Zimmer Biomet’s mymobility app paired with the Apple Watch can effectively guide rehabilitation following knee-replacement surgery.

Minute Insights Digital Health
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