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Live Raccoons, Dead Possum Bring Consent Decree To Arkansas Distributor

A new consent decree requires an Arkansas distributor to stop selling medical devices and other FDA-regulated products after an inspection found rodents, insects and other animals at the company’s warehouses.

Enforcement Quality Control FDA

Start-Up Spotlight: SetPoint Develops Vagus Nerve Stimulation To Treat Crohn's Disease And Rheumatoid Arthritis

SetPoint Medical is developing vagus nerve stimulation technology for Crohn’s disease and rheumatoid arthritis and believes it will be a "platform technology" for treating a variety of autoimmune diseases.

Start-up Spotlight Commercial Clinical Trials

Commission Offers One-Stop Shop For Vigilance Information And Offers Vital Spreadsheet

Vigilance is one area where the European Commission is sharpening up tools and practices now, with one eye on the new medtech regulations, too. Here we summarize key aspects of latest developments of which industry needs to be aware.

Europe International Medical Device

Abbott Delivers Strong Q2 Sales, Led By Spike In FreeStyle Libre Sales

Abbott delivered solid sales growth in the second quarter of 2019, topping analyst expectations. The company reported worldwide sales of $8bn, up 2.7% with Medical Devices highlighted as a standout division, delivering 10.5% organic growth.

Diabetic Care Commercial Companies

Device Week, 19 July 2019 – All About Earnings: Johnson & Johnson's Leadership Remains Optimistic; Abbott Delivers Strong Second Quarter

In this edition of Device Week, Medtech Insight's managing editor Marion Webb chats with deputy editor Reed Miller about recent earning reports from medtech giants Johnson & Johnson and Abbott.


Device Week Approvals FDA

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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Outdated medtech IT solutions are stopping people from efficiently performing their jobs, a survey has found.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

Compliance Corner: These Are The 6 Top Process Validation Mistakes Made By Firms, According To An FDA Investigator

US FDA investigator Ben Dastoli sees medical device manufacturers making the same process validation mistakes over and over. Here are the top six validation problems he sees.

Compliance Corner FDA Enforcement

Repealing 2.3% Device Tax Not On Candidate Klobuchar’s '100 Days Plan'

Democratic presidential candidate Sen. Amy Klobuchar of Minnesota has long been a strong supporter of the medical device industry and has been fighting to repeal the 2.3% medical device excise tax instituted as part of the Affordable Care Act. However, she did not include it as a priority for her administration if she is voted into office in 2020, and seems to be distancing herself from the industry.

Policy Legislation Lobbying

CMS Expands Ambulatory Blood Pressure Monitoring Coverage

The US Medicare agency has decided that evidence is sufficient to cover ambulatory blood pressure monitoring to help diagnose hypertension in beneficiaries who suffer from white coat high blood pressure, and those with suspected masked hypertension.

Reimbursement Medicare

Will Commission’s Standards Request Create An International Headache And EU Divergence?

Trying to meet standards that are currently in a state of flux and which are the source of more uncertainty adds another layer of stress to medtech manufacturers already trying to comply with an incomplete medtech regulatory structure.

Medical Device In Vitro Diagnostics

QUOTED. 18 July 2019. Suzanne Schwartz.

The US FDA's Suzanne Schwartz says a new law might be the antidote to companies that willingly hide cybersecurity vulnerabilities to avoid concerning their customers. Check out her comments here.

Quoted Cybersecurity

Hearing Implants Could Harm Shunt Function, FDA Warns

Some implanted hearing devices, such as cochlear implants, may magnetically interfere with programmable cerebrospinal fluid shunt systems, the US agency says.

Safety Regulation

Got A Better Idea? US FDA Seeks Help Tackling Ethylene Oxide Troubles

Regulators are reaching out to industry and the public-at-large for ideas that would help develop new sterilization methods that could reduce or replace the need for ethylene oxide used to treat difficult-to-clean medical devices. They are also looking for ways to reduce the risk and environmental impact of the sterilizing agent.

Regulation Safety

WHO Updates Essential Diagnostics List

The World Health Organization has added cancer diagnostics, blood-transplant screening and more to an updated list of essential diagnostics.

International In Vitro Diagnostics

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Thermo Fisher VP Wants More IVD Firms Involved In FDA's Manufacturing Maturity Program (Even Though His Company Isn't)

Peter Shearstone, VP of global quality assurance and regulatory affairs at in vitro diagnostic test-maker Thermo Fisher Scientific, is dismayed that only two IVD manufacturers are playing in the US FDA's Case for Quality Voluntary Improvement Program to measure manufacturing maturity and quality – and his firm isn't one of them. "Part of my challenge is moving my company toward proactivity, and if [CFQ VIP] can help do that, then I'd be hypocritical if I didn't embrace it," he says.

FDA Manufacturing

Catching Fire: FDA's Manufacturing Maturity Program For Devices Spreading Internationally – And To Drug Facilities

The US agency's Case for Quality Voluntary Improvement Program – used to measure a device-maker's manufacturing maturity and quality – has surprisingly been used to assess some pharmaceutical facilities. Meanwhile, regulators from other countries have been reaching out informally to the FDA to learn more about CFQ VIP.

FDA Manufacturing

Compliance Corner: How A Firm Handles Nonconforming Products Can Make Or Break Its FDA Inspection, Investigator Says

US FDA investigator and medical device specialist Thomas Peter says workers at device companies often fail to identify nonconforming products and don't adequately document troubles when they're discovered. Using quality audits is one way to nip this problem in the bud, he explains.

Compliance Corner FDA

Commercial Explore this Topic

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Johnson & Johnson Growth Led By Biosense Webster And Cerenovus

Johnson & Johnson’s leadership remains optimistic about the future of its medical device divisions despite reporting a 2.6% revenue decline in the first six months of 2019 compared to the same period of 2018.

Sales & Earnings Orthopedics Cardiovascular

International Demand For Robotic Surgery Drives Intuitive Surgical’s Revenues Up 21% in Q2

Intuitive Surgical reported on 18 July that worldwide da Vinci procedures were up about 17% in the second quarter of 2019 compared to the same period of 2018. While the US still accounts for the majority of Intuitive’s revenue, procedure volume outside the US is growing faster, especially in Asia.

Companies Sales & Earnings

Arthrosurface Markets First Allograft Implant To Replace Arthritic Thumb Bone

Orthopedic implant company Arthrosurface is hoping to get hand surgeons' attention with its new allograft thumb implant to treat osteoarthritis.

Orthopedics Orthopedics

QUOTED. 19 July 2019. Miles White.

Abbott Laboratories plans to invest significantly to expand manufacturing capacity for its FreeStyle Libre continuous glucose monitoring system in an effort to meet demand. See what Abbott CEO Miles White said about it here.

Quoted Diabetic Care

New US State And Proposed Federal Laws Would Stop Specialists From Balance Billing

A crop of new US consumer protection state laws and proposed federal legislation is aimed at stopping medical specialists from the practice of balance billing.

Legislation Reimbursement

Market Brief: The Need For Safer Needles, Syringes Will Drive Global Injection Devices Market Growth By 2023

Accelerating technological innovation, reimbursement and legislative changes are expected to make a significant impact on the global market of injection devices and related products. According to Informa's new Meddevicetracker report on "Infection Control and Biosafety Products," the combined market of these devices will reach $4bn by 2023.

Market Intelligence Infectious Diseases

Factory Explosion Expected To Cost Consort Millions In Profit

Consort Medical issued a profit warning following a factory explosion. The company said the incident is likely to cut between £3-5m from its annual profits.

Manufacturing Commercial

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Global Device Approvals Snapshot: 9-15 July 2019; MitraClip G4, Relievion, RAPID Imaging, ExAblate Neuro

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. The week of 9-15 July was another slow one for US FDA approvals, with no new PMAs, panel-track PMA supplements, or de novos. Informa’s Meddevicetracker reported three non-US approvals during the week.

Approvals Innovation FDA

Siemens Healthineers And University of Missouri System Sign 10-Year, $133M Partnership Agreement To Drive Innovation, Precision Medicine

Siemens Healthineers and the University of Missouri System and Missouri Health Care entered a 10-year strategic alliance worth $133M to collaborate on research projects, develop student curricula and leverage digital technology to drive health care. 

Deals Artificial Intelligence

Lights, Camera … Surgery? FDA Lays Out IDE Live Presentation Rules

New final guidance from the US FDA sets out the agency’s expectations for the use of live-case presentations during device clinical trials, focusing on patient protection.

Clinical Trials Guidance Documents

Breakthrough Status, Big Investments For Liquid Biopsies

The growth potential of liquid biopsy diagnostics is drawing increasing attention, with several recent breakthrough device designations from the US FDA, big funding rounds, and major acquisitions all in play.

Diagnostics Commercial

QUOTED. 9 July 2019. Vivek Reddy.

A new analysis suggests that Boston Scientific Corp.'s Watchman left-atrial appendage closure device is a cost-effective alternative to warfarin or other anticoagulant drugs for patients with atrial fibrillation. See what Vivek Reddy of the Mount Sinai Hospital said about it here.

Quoted Clinical Trials

Global Device Approvals Snapshot: 2-8 July 2019

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. The week of 2 July to 8 July was another slow one for approvals, with no new PMAs, panel-track PMA supplements, de novos, or non-US approvals.

Approvals Innovation

Device Week, 8 July 2019: Highlights From The AdvaMed Conference; Boston Scientific Continues To Build Case For Watchman

In this edition of Device Week, Medtech Insight’s Marion Webb reviews her interview with Omron Healthcare CEO Ranndy Kellogg at the recent AdvaMed conference in San Francisco. Reed Miller discusses the latest cost-effectiveness study of Boston Scientific’s Watchman left-atrial appendage closure device.

Device Week Commercial