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One Small Step For US FDA, But Maybe A Giant Leap For SaMDs

In a midyear update from the FDA, regulators say a retrospective review of companies in its pre-cert pilot program has concluded that evaluating a company for excellence markers could be sufficient to let Software as a Medical Device (SaMD) onto the market. However, at least one critic says the update doesn’t answer some of the most critical questions about whether the program meets the agency's own requirements and if it creates unfair advantages for certain companies.

Regulation Digital Health FDA

Execs On The Move: Top Management Changes At Ablative Solutions And ReShape; New Med Board At Cernostics

Renal denervation firm Ablative Solutions welcomes new a CEO; obesity and metabolic diseases company ReShape Lifesciences hires a commercial SVP; cancer diagnostics-developer Cernostics forms a medical advisory board; and more.

Appointments Commercial Medical Device

No Do-Over Needed In Supreme Court Patent Case, Stryker Says

The US Supreme Court doesn’t need to take a second look at a 2016 ruling on when parties found responsible for patent infringement must pay trebled damages, medical device giant Stryker told the court in a recent filing. Previously, federal courts had ordered fellow device-maker Zimmer to pay almost $250m to Stryker for violating patents on a wound-debridement device.

Intellectual Property Legal Issues United States

Strong China Sales Boost Q2 Results For Philips

Dutch health giant Philips reported Q2 results 22 July, showing better-than-expected sales across its medtech businesses. Strong growth in China and North America boosted the firm’s diagnosis and treatment businesses by 6% from the same period last year.

China Sales & Earnings Commercial

QUOTED. 23 July 2019. Amy Klobuchar.

Speaking to reporters at the National Press Club in Washington, DC, Democratic presidential candidate US Sen. Amy Klobuchar downplayed the need for action on repealing the 2.3% medical device tax as part of her “100 Days Plan” if she were to win the presidency. Check out the senator's comments here.

Quoted Politics Policy

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Outdated medtech IT solutions are stopping people from efficiently performing their jobs, a survey has found.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

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Policy & Regulation Explore this Topic

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Interview: EU Standards Hiatus Will Cost Manufacturers And Notified Bodies More Time And Resources

Compliance with the new EU medtech regulations was never going to be easy. But delays in the work to create the standards  ̶   the very tools that are designed to help manufacturers and notified bodies  ̶  now threaten to create even more uncertainty and further delays all round.

EU Europe Regulation

Pakistan Sets End 2019 Deadline For Filing Under New Medtech Regulations

Pakistan’s health care market is set to be unlocked when new medical technology regulations are put in place fully this year. But it has been a learning curve so far, MedTech Summit delegates heard in June.

Pakistan Regulation Medical Device

Warning Letter Roundup & Recap – 23 July 2019

No device-related warning letters were released by the US FDA the week of 23 July.

Device Warning Letters FDA

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

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

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

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

Quality Control & Compliance Explore this Topic

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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

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

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

Commercial Explore this Topic

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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

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

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

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

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

Clinical R&D Explore this Topic

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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

Global Device Approvals Snapshot For 16-22 July 2019: MED-EL Cochlear Implant, Novilase Breast Therapy

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, the US FDA approved a panel-track PMA supplement for an expanded indication for MED-EL’s cochlear implant, and Novian Health’s Novilase breast cancer treatment earned a CE mark.

Approvals Innovation

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
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