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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 Pricing Strategies

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 Medical Device

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 Respiratory

Siemens Cybersecurity Expert Says Medtech Industry Has 'Perverse Incentive' To Not Disclose Vulnerabilities – Might A New Law Be The Fix?

The fear of losing business by being transparent about cybersecurity vulnerabilities means there's "a perverse incentive in some parts of the market that encourages a lack of disclosure," Siemens' Harrison Wadsworth says. But the US FDA's Suzanne Schwartz believes coordinated vulnerability disclosure legislation could "level the playing field."

Cybersecurity Safety Legislation

QUOTED. 17 July 2019. Peter Shearstone.

Thermo Fisher Scientific's Peter Shearstone is urging fellow in vitro diagnostic firms to play in the US FDA's Case for Quality Voluntary Improvement Program (CFQ VIP). See what he said here.

Quoted FDA Manufacturing

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Medtech IT: How To Stay Ahead As Technology Accelerates

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Policy & Regulation Explore this Topic

Set Alert for Policy

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 Advisory Committees

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 Policy

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

Views Differ On Australian Proposal To Link Review Of CDx With Drugs

An Australian proposal to establish a regulatory framework for companion diagnostics has drawn a mixed response from pharmaceutical, biotech and medtech companies on issues like concurrent evaluation, product classification and unique identification.

Australia Regulation

Warning Letter Roundup & Recap – 16 July 2019

No device-related warning letters were released by the US FDA the week of 16 July.

Device Warning Letters FDA

Commission's Latest Stats Show How 10 MDR/IVDR Notified Bodies By Q3 2019 Is Now Possible

The European Commission’s latest figures indicate that at least 20 notified bodies will be designated by 26 May 2020 - the date by which the new medical device regulation will become fully applicable. But is there still enough time?

Europe Medical Device

UPDATE: EU Standards: Potential Hiatus As Priorities, Deadlines And Timeframes Take Shape

The European Commission’s long overdue MDR/IVDR standards request document – still a draft – gives the European standards bodies just over a week from today to respond. But CEN/Cenelec says it cannot reply yet. So what is the problem?

Medical Device Europe

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

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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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 Companies

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

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

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

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

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

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

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
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