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CMS Proposes Dialysis Pay Models In Response To Executive Order On Kidney Health

Prompted by a presidential executive order on advancing kidney health, the US Medicare agency has proposed five new end-stage renal disease (ESRD) payment models to encourage greater use of home dialysis and kidney transplants to Medicare and Medicaid beneficiaries.

Government Payers Medicare Reimbursement

EU Standards: Priorities, Deadlines And Timeframes Take Shape

The European Commission has taken a step towards the EU having standards available to meet MDR/IVDR requirements. But is overall progress too slow? And will a shortage of updated standards be another hurdle for manufacturers in what is turning out to be an obstacle course rather than a race to full compliance?

Medical Device Europe Policy & Regulation

Execs On The Move: New Chief Officers At Nevro And Integra; Cerapedics Adds Development Exec

Nevro, a pain device company, added a chief commercial officer from Abbott Vascular; Integra Lifesciences moved its top finance boss to chief operating officer; a Spinal Kinetics exec joined orthobiologics company Cerapedics to lead its clinical and market development; and more.

Appointments Commercial Medical Device

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

QUOTED. 15 July 2019. Christy Wyskiel.

Liquid biopsy technology is drawing increasing attention from regulators, big manufacturers and investors alike as recent developments in this field show. See what Johns Hopkins's head of technology ventures, Christy Wyskiel, said about it here.

Quoted Innovation Diagnostics

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Outdated medtech IT solutions are stopping people from efficiently performing their jobs, a survey has found.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

Set Alert for Policy

US Trade Representative Removes Host Of Devices, Parts From China Tariff List

The US Trade Representative’s Office has agreed to remove a group of medtech products and components from its list of those imported from China that initially would be tariffed at 25%, making its exclusion-from-tariffs decision retroactive one year, and extending the exclusion to 9 July 2020.

Trade Tax Politics

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 In Vitro Diagnostics

Class I Recall Tied To Ventilator Error Message

A ventilator error message that leaves patients breathing room air has led to a high-risk class I recall for Hamilton Medical.

Recalls Compliance

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

The Evidence Is In: Australia Recommends Breast Implant Ban

The Therapeutic Goods Administration says it now has enough evidence to warrant cancelling, suspending and recalling a number of textured breast implants because of the potential risks of developing anaplastic large cell lymphoma.

Recalls Australia

Will Recent Notified Body Losses Persuade Commission That Action Is Now Needed?

Industry and the European Commission have been at loggerheads over whether the new EU Medical Device Regulation will be ready on time and whether a further extension is needed. Could recent notified body developments fuel the case for an extension?

Medical Device Europe

Despite Paclitaxel Warnings, Physicians Endorse Boston Sci’s Eluvia Stent For NTAP In CMS Pay Proposal Comments

Cardiologists and radiologists spoke in support of new technology add-on payments for Boston Scientific’s Eluvia drug-eluting stent, used to treat patients with peripheral artery disease, in comments on the US Medicare agency's Inpatient Prospective Payment System (IPPS) rule for 2020, despite concerns about paclitaxel-coated stents discussed at a late June US FDA Advisory Committee meeting.

Reimbursement Medicare

How The MHRA Is Ready For No-Deal Brexit Impact But Can’t Influence Other Authorities

In terms of a no-deal Brexit, the UK MHRA had drawn up its plans for medtech several months ago and is sticking by them. But even though manufacturers seemingly have more time to prepare for the delayed Brexit deadline, they should not underestimate the volume of work ahead.

Europe United Kingdom

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

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

Medtech Tips: How To Design With Safety In Mind

Guest authors Laura Dhatt and Paul Kostek of software engineering services firm Base2 Solutions offer device-makers pointers on how to mitigate certain risks and make sure that safety is always a top concern when products are designed.

Medtech Tips Safety

Commercial Explore this Topic

Set Alert for Commercial

Market Brief: The Global Market For Prostate Cancer Diagnostics Will Reach $460.5M In 2023

The global market for prostate cancer diagnostics is expected to see double-digit growth, reaching $460.5m in 2023 and is driven by new technologies, in particular liquid biopsies and new genetic marker tests, according to a new report by Informa's Meddevicetracker.

Innovation Market Intelligence Commercial

QUOTED. 12 July 2019. Carlos Nunez.

A new multinational study by sleep device-maker ResMed and 12 academic leaders in sleep research found that nearly one billion people worldwide have sleep apnea, about 10 times higher than previous estimates by the World Health Organization. See what study co-author and ResMed's CMO, Carlos Nunez, said about it here.

Quoted Respiratory

Market Brief: Global Market For Implantable Defibrillators Will Reach $10Bn By 2023

The global market for implantable cardioverter defibrillators (ICDs) is expected to reach $10bn by 2023, a CAGR of 4.4%, driven by the rising prevalence of heart disease worldwide. This market is dominated by three players, Abbott, Boston Scientific and Medtronic, which continue to innovate. Cost of ICDs and surgical implantation remain barriers to wider adoption, but access to emerging markets is expected to drive sales.

Market Intelligence Cardiology

MDMA Praises Reintroduction Of STRONGER Patents Act In Senate

The Medical Device Manufacturers Association (MDMA) on 10 July praised US Senate reintroduction of the STRONGER Patents Act, designed to strengthen the US patents systems by making it easier and less costly for patent-holders to enforce their patents, including those which are the intellectual property of device-makers.  Mirror legislation was simultaneously proposed in the US House.

Legislation Intellectual Property

QUOTED. 11 July 2019. Ranndy Kellogg.

This year, Omron Healthcare introduced its new HeartGuide smartwatch and the first US FDA-cleared blood pressure monitor with EKG capability, Complete, which it developed in partnership with AliveCor. See what Omron's CEO, Ranndy Kellogg, said about the company's plans here.

Quoted Innovation

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. 10 July 2019. Michael Friedrich.

Switzerland-based robotics company Distalmotion hopes to win marketing approval in Europe for Dexter, a robotic surgery system designed to help surgeons with long and complex surgical tasks. See what Distalmotion's CEO Michael Friedrich said about it here.

Quoted Start-up Spotlight

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

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 Digital Health

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

Long-Term Analysis Shows Boston Scientific’s Watchman Device Saves Money

An analysis of pooled five-year data from the PROTECT AF and PREVAIL trials, show left-atrial appendage closure to prevent stroke in patients with atrial fibrillation is not only cost‐effective compared to treatment with warfarin and other anticoagulant drugs, but saves money over time.

Clinical Trials Cost Effectiveness
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