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EU MDR: Medtechs Must Look At The Bigger Picture Of Regulatory Compliance

The EU MDR represents the biggest collective change in many years for medtech companies in terms of how they prepare their approach to market. With time running short for companies’ preparations ahead of the regulation’s implementation date of 26 May next year, the UK ABHI’s final pre-MDR regulatory conference in late October will be both a check list for companies en route to compliance and a debate about the wider role of risk in regulatory compliance.

EU Medical Device Regulation

Diabetes, Mitral Repair And Diagnostics Drive Big Quarter For Abbott

Abbott Laboratories’ medical device businesses grew 10.6% year over year in the third quarter of 2019 while its diagnostics business grew 6.6%, helping the company grow 7.6% overall, the company reported on 16 October.

Commercial Sales & Earnings Diabetic Care

Rising Procedure Volumes Push Intuitive Surgical Third-Quarter Earnings Above Forecast

Intuitive Surgical reported higher-than-expected third-quarter revenues with strong procedure growth and on-going adoption of the da Vinci system in the US and outside of the US.

Sales & Earnings Robotic Surgery Surgical Procedures

China Joins International Post-Market Surveillance Program

China’s National Medical Products Administration says that participating in the International Medical Device Regulators Forum’s program will help it control the risks associated with imported products.

China Safety Post Market Regulation & Studies

QUOTED. 21 October 2019. Zach Rothstein.

AdvaMed has launched a Center for Digital Health to aggregate its resources and coordinate efforts to lobby the government on behalf of digital-health companies, among others on how to pay for new digital-health products. See what Zach Rothstein, AdvaMed's VP for technology and regulatory affairs, said about it here.

Regulation Lobbying Policy

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Recent Tweets from Medtech Insight

Medtech IT: How To Stay Ahead As Technology Accelerates

Outdated medtech IT solutions are stopping people from efficiently performing their jobs, a survey has found. Read this whitepaper to view more survey results and discusses how tech is changing Medtech.

Read the Whitepaper

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

EU Or US First Choice For Launching Innovative Products? What You Really Need To Know

The tightening of the EU regulatory system will increase timelines for the availability of devices, especially novel, high-risk devices. But those who believe the US system will be quicker should not be so eager to jump to conclusions. Clinical data expert Sarah Sorrel explains why.

Medical Device Europe North America

US House Panel Advances Bill Allowing Medicare Coverage Of Eyeglasses, Hearing Aids, Dental Services

Bills permitting Medicare coverage of eyeglasses, hearing aids, dental implants and the exams needed for prescriptions for these medical products were approved by the US House Energy and Commerce Committee on 17 October, and passed onto the full House for its consideration.

Policy Legislation Medicare

Reimbursement A Top Goal For New Digital Health Lobbying Center

As digital health becomes more ubiquitous in the medical device space, industry advocacy group AdvaMed has launched a Center for Digital Health to aggregate its resources and coordinate efforts to lobby the government on behalf of digital-health companies.

Regulation Policy

Self-Care Devices May See Extension After EU Commission Admits MDR ‘Inconsistencies’

Self-care medical devices may be included in the four-year “grace period” following implementation of the new EU Medical Device Regulation as part of an incoming corrigendum to the law, a spokesperson for the European Commission suggested at a recent AESGP meeting.

OTC Devices Regulation

QUOTED. 18 October 2019. CJ Porter.

New Orleans-based UTC Laboratories agreed to pay $41.6m to resolve alleged violations of the False Claims Act, the US Department of Justice (DOJ) announced recently. See what CJ Porter, special agent in charge with the Department of Health and Human Service Office of the Inspector General, said about it here.

Quoted Enforcement

Personalized Medicine Firm Pays $42M On Kickback Allegations Tied To Genetic-Testing Registry

Louisiana-based pharmacogenetic testing company UTC Laboratories and its three principals have agreed to pay $42.6m to resolve allegations that the company violated the False Claims Act by paying kickbacks for referrals and providing tests that were not medically necessary.

Diagnostics Enforcement

Reprieve For Life Sciences As Brexit Deal Approved

The Brexit withdrawal deal agreed by the UK and the EU on 17 October would see the UK leave the EU at the end of the month, but would allow time to negotiate the future trading and regulatory relationship between the two parties. However, the deal still faces a rough passage in the UK parliament.

United Kingdom Brexit

Graeme Tunbridge To Lead MHRA Devices Unit During Interim, Reports Indicate

Today is John Wilkinson’s last day as head of devices at the UK’s MHRA. It looks like his successor will be someone who can ably assist in the transition ahead, as the UK copes with upcoming Brexit arrangements and the EU attempts to successfully implement the new Medical Device and IVD Regulations.

Medical Device Europe

Quality Control & Compliance Explore this Topic

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Compliance Corner: Cybersecurity Patches Aren't Recall Events – But A New 510(k) May Be Needed Over Time, Expert Says

Eric Henry with the law firm King & Spalding says that while software cybersecurity patches typically don't rise to the level of a recall, device-makers should still consider the cumulative effect of software changes on products.

Compliance Corner Cybersecurity

Warning Letter Roundup & Recap – 15 October 2019

In the only device-related warning letter released by the US FDA this week, a manufacturer of a dental X-ray sensor and X-ray system was cited for quality systems violations. The firm also failed to notify the agency of accidental radiation occurrences.

Device Warning Letters FDA

Device Week, 11 October 2019 – Total Recall: The Latest On Corrections & Removals

On this week’s podcast, executive editor Shawn M. Schmitt and senior reporter Elizabeth Orr delve into recent news on medical device recalls, including tips and advice from US FDA officials, and a report about a new app that scans products and gives detailed safety and recall information.

Device Week Recalls

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Device Week, 17 October 2019 – A Mix Of Earnings and 'Taboo' Tech: Johnson & Johnson's Third-Quarter Earnings; Tech Innovations Around Sex And Death

In this edition of Device Week, Medtech Insight managing editor Marion Webb chats with deputy editor Reed Miller about the most recent earnings report from Johnson & Johnson, and talks with London-based Catherine Longworth about her upcoming "taboo" tech coverage from the 2019 Global Innovation and New Technology Health Event (GIANT).

Device Week Commercial Innovation

J&J To Pay $117M, Resolving Mesh Marketing Suits In 41 States

Johnson & Johnson and subsidiary Ethicon will pay $117m to settle state lawsuits alleging that their marketing misrepresented the safety and risks of transvaginal mesh devices.

Medical Device Commercial

Pentax Medical Pushes People, Product And Process Amid New US FDA Guidance

With the US FDA urging providers to transition away from fixed duodenoscopes to newer designs that reduce or eliminate reprocessing of the device, Pentax Medical is seizing an opportunity to increase supply of its disposable cap scope. Medtech Insight talks to the company’s global clinical officer, Garrett Hudson, on the challenges of endoscopy hygiene and the company’s response to guidance.

FDA Gastroenterology

QUOTED. 17 October 2019. Ashley McEvoy.

Johnson & Johnson's medical device businesses grew 5.3% on an organic basis in the third quarter led by the Bioscience Webster electrophysiology unit. See what Ashley McEvoy, Johnson & Johnson's worldwide chairman for medical devices, said during the earnings call here.

Quoted Sales & Earnings

J&J’s Investment In Medical Device Businesses Is Starting To Pay Off

Johnson & Johnson's medical device businesses grew 5.3% on an organic basis in the third quarter, led by the Biosense Webster electrophysiology business. The company is increasing R&D investment, especially in robotic surgery, to boost its surgery and orthopedics businesses.

Commercial Sales & Earnings

Execs On The Move: An Exit And A Promotion For Chief Officers At Qiagen And Halma

CEO of molecular diagnostics firm Qiagen steps down after decades of service; Halma division chief steps up to medical and environmental sector chief exec; and more.

Appointments Commercial

QUOTED. 16 October 2019. John Sheridan.

Abbott signed a deal with Tandem Diabetes Care to develop diabetes solutions combining Abbott's glucose-sensing technology with Tandem's insulin delivery systems. See what Tandem's CEO and president, John Sheridan, said about the partnership here.

Quoted Diabetic Care

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

German Patient Data Shows No Paclitaxel Mortality Risk

A review of German insurance data found no additional risk of death in patients treated with drug-coated balloons and stents, even in patients who had the devices for more than a decade. The data appears to further challenge a bombshell meta-analysis that claimed paclitaxel could increase death rates by up to 90%.

Germany Medical Device Cardiology

Ethicon Expects Powered Circular Stapler To Address A Common Source Of Cancer Surgery Complications

The Echelon circular powered stapler for colorectal, gastric and thoracic surgery features Ethicon’s 3D stapling technology to evenly distribute compression and a gripping-surface technology that reduces compressive forces on tissue. The company expects the new system will reduce leaks at the staple line without compromising blood or lymphatic perfusion.

Innovation Research & Development

Abbott Launches New App To Keep Heart Failure Patients Out Of The Hospital

The Merlin 10.0 update to Abbott’s its Merlin patient care network, which works with the CardioMEMS HF sensor system, allows physicians to communicate directly with patients.

Digital Health Innovation

Device Week, 4 October 2019 – Demant Group Recovers From Cyber-Attack; TCT Conference Highlights

In this week's podcast, senior reporter Catherine Longworth provides an update on how the Demant Group is recovering from a ransomware attack that forced the Danish hearing-aid manufacturer to shut down its IT systems, and deputy editor Reed Miller reviews the highlights of the clinical trial presentations at the recent Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco.

Device Week Commercial

TCT 2019: EXCEL Shows Similar Five-Year Outcomes With PCI And Surgery In Left-Main Disease

Intervention with Abbott’s Xience everolimus-eluting stent yielded similar long-term results as bypass surgery in the EXCEL trial.

Clinical Trials Research & Development

TCT 2019: Abbott’s Portico TAVR Crosses Non-Inferiority Threshold

Abbott’s Portico transcatheter aortic valve performed well enough to meet the statistical criteria for non-inferiority to surgery in the PORTICO IDE trial. The company will likely look to its next-generation of Portico for more impressive results.

Clinical Trials Research & Development

TCT 2019: One-Year PARTNER 3 Outcomes Show Better Quality Of Life With TAVR

An analysis of the PARTNER 3 trial shows transcatheter aortic replacement with Edwards Sapien 3 yields better health status outcomes than surgical valve replacement after one year.

Clinical Trials Research & Development