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Featured Stories

Medtech Monthly, Ep. 1: Quality Vs. Compliance

Medtech Monthly is here! Check out the first episode of Medtech Insight's new podcast series: It's a knock-down (not really), drag-out (not really), freewheelin' (very much so) conversation about quality versus compliance, with the US FDA's Cisco Vicenty in one corner, and former FDA compliance chief Steve Silverman in the other.

Medtech Monthly Quality Compliance

Minute Insight: Acutus Adds Another Device To The Left-Heart Business It Sold To Medtronic

The company announced the US launch of the AcQCross Qx transseptal dilator/needle. It is specifically designed to help deploy Boston Scientific’s Watchman left-atrial appendage closure device, but it is part of the left-heart access device portfolio that Acutus recently sold to Medtronic.

Minute Insights Launches Approvals

MHRA Offers Medtechs Extra Transition Time For UK Regulatory System Compliance

26 June saw the release finally of the UK government’s official response to the MHRA’s 2021 consultation on its post-Brexit medical devices regulatory framework. The considered response, held up by political and internal timing issues, represents an implementation plan for reform of the system. Crucially it allows industry extra compliance time.

United Kingdom Regulation Medical Device

How Europe’s Nomenclature System Works And Offers New Insights

Transparency linked to new device registration rules will provide new market analysis possibilities. Medtech Insight delved deeper into the benefits of the European Medical Device Nomenclature with two Italian executives who see its potential.

EU Europe Compliance

Spotlight On Exec Chats

Exec Chat: Biosense Webster Is Ready For Next Chapters Of The Electrophysiology Story

Medtech Insight talked to Michael Bodner, the worldwide president of Johnson & Johnson/Biosense Webster, about the company’s plans to stay number one in the cardiac ablation market. In part 1 of the interview, the medtech veteran talked about the company's plan to compete in the crowded pulsed field ablation field.

Exec Chats Cardiovascular

For Second Time This Month, Medtronic Announces Class I FDA Recall Related To HeartWare System Component

Medtronic, Baxter and BD are all facing recalls, with Medtronic finding yet another issue with HeartWare HVAD systems. Separately, the FDA put a Baxter respiratory device recall into Class I, and BD announced a recall on intraosseous devices.

FDA Enforcement Recalls

Novel VR Treatment For Mental Illness Gets FDA Breakthrough

The US FDA has granted its breakthrough designation to a virtual reality therapy that recreates everyday scenarios for patients dealing with severe anxiety and schizophrenia.

FDA Approvals Clinical Trials

Abbott Announces Another Health Equity Initiative

The Abbott Fund, the company’s charitable foundation, has granted Easterseals $750,000 to fund a three-year pilot project supporting education and community health equity.

Diversity & Inclusion Sustainability Pediatrics

Device Week Podcast


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Policy & Regulation Explore this Topic

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EU Project Findings To ‘Instil Confidence’ In Using Patient Preference Studies

The European Medicines Agency’s endorsement of a framework that explains how medical device and drug sponsors can use patient preference studies to answer their research questions could help increase confidence in the conduct and acceptability of such studies.

Europe Regulation Clinical Trials

Compliance Corner: Review Risks When Making Product Or Process Changes, FDA Official Warns

The US FDA compliance officer says medtech manufacturers would be wise to evaluate changes to stay out of hot water with the agency.

Compliance Corner Risk Management FDA

Latest From Policy & Regulation

Class I Recall For GE Healthcare CARESCAPE Ventilator

The US FDA has designated GE Healthcare’s recall of its CARESCAPE R860 ventilator as Class I, the agency’s most serious category.

FDA Recalls

Go-Ahead For Appointment Of European Union Reference Labs For IVDs

EURLs have been a critical missing element of the IVDR for assessing the higher-risk class D IVDs. Two new implementing regulations, on fees and tasks, bring them closer to designation.

EU Europe

NICE: Real-World Evidence Revolution Will Drive UK’s Health Care Innovation

In its just-released real-world evidence framework, NICE assesses the role and value of data collected outside highly-controlled clinical studies in driving more innovation towards health care professionals.

United Kingdom Health Technology Assessment

EU Medtech Industry Keeps Watchful Eye On Changing Needs In Ukraine

Ukraine’s medical supply needs have evolved since Russia launched its military invasion of the country on 24 February. EU healthcare decision makers and the medical technology industry have since stood firm in their support of the besieged country, said MedTech Europe’s Jesús Rueda.

Europe Ukraine

Beyond Lockdown: The Digitization Of Chinese Hospitals Continues Apace

The recent COVID-19 lockdown in Shanghai caused widespread disruption locally and an economic slowdown for China. But it did not interrupt the ongoing digitization of health care, the value of which was once again thrown into sharp relief, writes news and analysis portal Omdia.

China Policy

Medtech Procurement A Victim Of Turkey’s Ongoing Economic Troubles

The devaluation of the Turkish Lira since May is making imports of medical devices more expensive and putting hospital procurement under renewed pressure. The local medtech industry associations TUMDEF and ARTED describe the problems  ̶  and the solutions  ̶  to Medtech Insight.

Turkey Medical Device

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Latest From Quality Control

Class I Recall For GE Healthcare CARESCAPE Ventilator

The US FDA has designated GE Healthcare’s recall of its CARESCAPE R860 ventilator as Class I, the agency’s most serious category.

FDA Recalls

Go-Ahead For Appointment Of European Union Reference Labs For IVDs

EURLs have been a critical missing element of the IVDR for assessing the higher-risk class D IVDs. Two new implementing regulations, on fees and tasks, bring them closer to designation.

EU Europe

FDA Issues Final Guidance For Radiological Devices Using Quantitative Imaging

The US FDA has published its final guidance for premarket submissions of radiological devices that use quantitative imaging – technology which offers clinicians a more accurate picture of a disease.

FDA Guidance Documents

Commercial Explore this Topic

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Happify Health Collaborates With Biogen To Support People Living With Multiple Sclerosis

Biogen and Happy Health announced a pilot partnership to evaluate Happify Health’s Kopa app to support people living with multiple sclerosis. This follows a licensing deal with digital therapeutics developer MedRhythms to support MS patients with gait deficit.

Digital Health Deals Business Strategies

Latest From Commercial

Cue Health Lays Off 170 People Amid Economic Challenges

COVID-test maker Cue Health said it laid off 170 people in its manufacturing facility but remains “confident in its long-term strategy.”

Coronavirus COVID-19 Business Strategies

Class I Recall For GE Healthcare CARESCAPE Ventilator

The US FDA has designated GE Healthcare’s recall of its CARESCAPE R860 ventilator as Class I, the agency’s most serious category.

FDA Recalls

Minute Insight: SonALAsense MR-Guided Ultrasound Drug-Device Combo Trials Get Green Light

SonALAsense has received Safe to Proceed letters from the FDA to begin trials of its ultrasound-activated cancer killing drug.

Drug Delivery Technology Clinical Trials

Minute Insight: Abbott Plans Move Into Famous Chicago Skyscraper

Local newspapers in Chicago confirm that Abbott is leasing space in Chicago’s most famous building in an attempt to better serve employees who live closer to the city than its Lake County, IL, campus.

Minute Insights Business Strategies

What Do Speedboats Have To Do with Surgery?

Nothing except a name, but Creo Medical says its Speedboat Inject device can turn some surgeries from prolonged hospital stays into one-day visits.

Platform Technologies Innovation

Report Digest: Chatting About Deep Brain And Vagus Nerve Stimulation

In this episode of Report Digest, UK-based reporter Barnaby Pickering speaks to analyst Mike Carmody about Meddevicetracker’s recent report on deep brain and Vagus nerve stimulation. The two discuss market players, recent tech developments and future potential for the market.

Market Intelligence Neurology

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Biden’s Biomedical Research Initiative Moves One Step Closer To Fruition

The US House of Representatives overwhelmingly passed legislation authorizing the creation of a federal health agency to advance biomedical research. The bill now goes to the Senate.

Legislation Innovation Policy

Latest From Research & Development

Digital Health Roundup: A Mixed Bag Of Exec Interviews; Femtech; Robotics; Digital OR; Wearables

In this month’s Digital Health roundup, Medtech Insight’s Marion Webb discusses her deep-dive article on menopause with leading experts in this rising industry and Barnaby Pickering highlights UK-based Proximie, which developed a web-based platform that allows surgeons and other clinical experts to collaborate virtually in the operating suite. The company recently raised $80m in a series C round.

Digital Health Artificial Intelligence

Cardio Catch-Up: Updates From B-Secur, egnite, Vektor, And Other Under-The-Radar Companies

This edition of Medtech Insight’s Cardiovascular Catch-Up features highlights from recent interviews with leaders of some not-so-famous companies addressing cardiovascular health from a variety of angles – from improving the traditional stethoscope to non-invasive 3D mapping of arrhythmias and more.

Cardiology Artificial Intelligence

Epic Sciences Talks Differentiation And Benefits Of Its DefineMBC Cancer Test

Epic Sciences spoke to Medtech Insight to discuss the development of its DefineMBC test for metastatic breast cancer.

In Vitro Diagnostics Cancer

Minute Insight: Senseonics Eversense E3 CGM Receives CE Mark, Launch Planned For Q3

Sensonics received the CE mark for its next-generation E3 CGM with plans to launch in the third quarter. It will be facing stiff competition from CGM makers Dexcom and Abbott in the European market. 

Approvals Diabetic Care

Cardio Catch-Up: Gel For Fixing Heart Attacks, ‘Uncaged’ Coronary Stents, And More

Medtech Insight’s Cardiovascular Catch-Up highlights recent news on cardiovascular tech innovations in the last two months. Part II of this month’s update includes innovative research and development news from smaller companies and research labs that you may have missed.

Cardiovascular Clinical Trials

Cardio Catch-Up: More Conferences, More New Data From Abbott And Medtronic

Medtech Insight’s Cardiovascular Catch-Up highlights some of the recent news on cardiovascular tech innovations in the last two months. This edition focuses on news from conferences, held over the last two months, including the Heart Rhythm Society and the TVT Structural Heart Summit.

Cardiovascular Clinical Trials
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