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Edwards Lifesciences Mike Mussallem To Retire As CEO, Bernard Zovighian Named Successor

Mussallem’s retirement at age 70 does not come as a surprise to the Street, but analysts expect some headwinds for his successor Bernard Zovighian, who has been heading the firm’s transcatheter mitral and tricuspid valve repair business.

Executive Changes Cardiovascular Cardiology

FDA Launches New Webpage Dedicated To AR And VR Medical Devices

The US Food and Drug Administration has launched a new webpage dedicated to medical devices that incorporate augmented reality and virtual reality technologies. The agency has approved some 39 AR/VR devices.

FDA Policy Medical Device

Another Italian Notified Body Designated Under MDR

This new listing is the tenth Italian notified body under the Medical Device Regulation, bringing the total number of notified bodies to 36.

Europe EU Italy

Deals Shaping The Medtech And Diagnostics Industry, December 2022

Medtech Insight's Deal-Making column is a survey of recent health care transactions listed by relevant industry segment – in vitro diagnostics and medical devices – and then categorized by type – acquisition, alliance, or financing. This month’s column covers deals announced in November 2022. Data provided by Citeline's Biomedtracker.

Deals M & A Medical Device

European Commission Proposal To Extend MDR Deadlines As Far As 2027 and 2028

The Commission will present a mixture of likely elements of a legislative proposal for a targeted amendment of the MDR and IVDR for consideration at the 9 December EPSCO Health Council meeting.

EU Medical Device Compliance

HLTH 2022: Neurotrack’s CEO Stresses Need For Three-Minute Digital Test To Detect Cognitive Decline Early

Neurotrack hopes to bring its three-minute digital cognitive assessment tool into primary care offices as part of the Medicare Annual Wellness visit.

Digital Health Neurology Behavioral Health

FDA Updates Abiomed’s Heart Pump Labeling After Post-Approval Clinical Study

The US Food and Drug Administration recently updated the labeling of Abiomed’s Impella RP System to reflect the latest results from a clinical study on the device. The FDA first approved the heart pump system in September 2017.

FDA Regulation Clinical Trials

Medtech Monthly Podcast

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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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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

Why EU Must Reform Regulation And Funding For Life-Saving Cancer Biomarker Tests

UK and EU patients have inadequate and inconsistent access to cancer biomarker tests, which experts warn is hindering the use of life-saving targeted medicines. Could parallel regulatory and reimbursement processes for drugs and diagnostics provide a solution?

Europe EU Medical Device

Latest From Policy & Regulation

Medtech Industry Says Latest EU AI Act Revisions Insufficient As Questions Remain

Recent revisions to the European Commission’s proposed AI Act have failed to resolve uncertainties around its interaction with medtech regulations, leaving crucial parts of the legislation open to interpretation. Industry representatives have said further steps must be taken.

Europe EU

Time is Ripe For Large-Scale German Hospital Reform – Health Ministry

DRGs are not doing what they were conceived to, ambulatory care needs more support and health care delivery across the country must be unburdened from bureaucracy, health minister Karl Lauterbach told the German hospital congress meeting during Medica 2022.

Germany Policy

EU MDCG Paper Sheds Some Light On Hybrid Audit Rules, But Questions Remain

How much time do auditors need to spend on a manufacturer’s premises? A new EU document aims to clarify this and other issues, but questions remain

Europe EU

Heads Of Medicines Agency Group Adds Another Authority Voice To Intense EU MDR Debate

EU member state authorities overseeing devices have been putting out a series of messages that promise action to ease the implementation chaos surrounding the EU’s new medtech regulations.

Europe EU

UK’s NICE Says ‘Light Touch’ HTA Evaluation Will Support Innovation

The UK’s health technology assessment body recognizes that its traditional product evaluation processes are too slow for innovative medtech products. Its new “conditional recommendation” pathway aims to fix this.

EU Europe

‘A Fuse Burning At Both Ends’: German Near-Term Market Outlook For Medtech Industry

Later market launch of innovations and a hit on EBITDA are simultaneously affecting medtech companies in Germany and central Europe as they strive to keep quality uppermost while battling the most frustrating confluence of negative effects on business than most companies have ever seen.

Germany Policy

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

EU MDCG Paper Sheds Some Light On Hybrid Audit Rules, But Questions Remain

How much time do auditors need to spend on a manufacturer’s premises? A new EU document aims to clarify this and other issues, but questions remain

Europe EU

Heads Of Medicines Agency Group Adds Another Authority Voice To Intense EU MDR Debate

EU member state authorities overseeing devices have been putting out a series of messages that promise action to ease the implementation chaos surrounding the EU’s new medtech regulations.

Europe EU

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

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Minute Insight: Titan Medical Cuts Costs As It Continues ‘Strategic Review’

The Canadian robotic surgery company is still working toward an FDA approval for its Enos single-access robotic surgery system, but is laying off 40 people in its Chapel Hill, NC, offices to save money.

Minute Insights Robotic Surgery Strategy

Latest From Commercial

Elypta Drops Data Showing Power Of Metabolite-Based MCED Test

Elypta’s MIRAM kit for multi-cancer early detection performed well in a large-scale study.

Cancer Diagnostics

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

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

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

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

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

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
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