Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Featured Stories


Market Intel: Managing Diabetes With Digital Apps: Physicians' Views On Pros And Cons

With a growing number of diabetes apps on the market, patients and physicians can obtain a large amount of data to help manage the disease. In this second part of a two-part series on the blood glucose monitoring devices market, two endocrinologists express their views on the considerations and pitfalls of using apps to help manage diabetes, and they recommend specific apps.

Diabetic Care Digital Health Commercial

UK Government Prioritizes Medical-Device Transport In No-Deal Brexit

The UK government has been working on plans to ensure medical devices, among other goods, can still "flow into the country, and won't be delayed by additional controls and checks."

Brexit Policy United Kingdom

Opinion: The Great Implant Scandal Or 7.7 Billion Reasons To Celebrate Medical Devices?

Investigative journalists, tort lawyers, the judicial system and public opinion all provide checks and balances on medical research, industrial innovation and commercial exploitation of health-care technologies. Whether those affected like it or not, these well-intentioned elements of society demand accountability of an industry that has a profound effect on all our lives. The "Implant Files" episode is a reminder for medtech stakeholders across the world that nothing can be taken for granted, says medtech industry and regulatory consultant Trevor Lewis in this guest column for Medtech Insight.

Implant Files Regulation Medical Device

MTI 100: Major M&A Bookends Year Of Mainly Steady Growth For Leading Medtech Groups

In Medtech Insight's latest rankings of top 100 revenue-earners in the medical device and diagnostics sector, it was steady as she goes for most of the multinational medtechs, with some major exceptions. But there will be more M&A reflected in next year's ranking based on 2018 revenues. Also, medtech groups leading the global market tightened their grip further in 2017, as providers chose to partner more and more with fewer suppliers who can offer a wider provision of services.

Commercial M & A Business Strategies

QUOTED. Dec. 11, 2018. Greg Crist.

US industry lobbyists are downplaying the practical impacts to the industry – at least so far – of the scathing report of medical malpractice, undue government influence, and questionable marketing practices published by the International Consortium of Investigative Journalists in recent weeks.

Quoted Policy Legislation

Latest from PR Newswire

Click here to access further medical device and diagnostics news.
 
Advertisement


Recent Tweets from Medtech Insight


Achieving Translation Quality Through Process Design

Quality assurance (QA) is always a governing principle in translation and language services. Download this whitepaper, which discusses how advanced technology enables translations to be produced more quickly, more accurately and potentially at a lower cost.

Download Whitepaper

Pharma Report Store

Have an immediate and specific information need?

Browse and buy from 1000s of analysis and research reports now:

Shop Now

Policy & Regulation Explore this Topic

Set Alert for Policy

'Lame Duck' Bill Would Halt Device Tax Until 2025

A revised tax bill introduced by the top lawmaker in the Ways and Means Committee could freeze the Obamacare medical device tax for an additional five years. It is expected a new Congress will be more politically contentious, making it harder to pass an extended moratorium or repeal the bill; this latest effort may be industry’s best chance.

Legislation Policy United States

When Medtech Companies Have Redress Against The European Commission: CJEU Ruling

The European Commission must, like everyone, ensure that it complies with its responsibilities within the context of EU rules governing medical devices. A recent European Court ruling may open the door for companies to seek compensation from the European Commission for related failures. Two attorneys explain.

Legal Issues Regulation Europe

US FDA Report Confirms Duodenoscope Contamination Risk

An early look at the results of post-market studies that had been ordered by US FDA for duodenoscopes highlights ongoing sterilization issues.

Safety Regulation

Warning Letter Roundup & Recap – Dec. 11, 2018

No device-related warning letters were released by US FDA the week of Dec 11.
Medical Device Device Warning Letters

US Asks Supreme Court To Drop Gilead False Claims Case

The US Solicitor General is advising the Supreme Court not to hear a suit challenging whether a False Claims Act suit can be brought if the government knows about the alleged misbehavior and continues to pay for the relevant products or services.

Legal Issues Enforcement

US Medtech Lobbyists Say They're Not Worried About Political Backlash From 'Implant Files'

The International Consortium of Investigative Journalists started publishing the findings of its "Implant Files" investigation last month, but the two main industry groups in the US have not picked up any significant political backlash resulting from the reporting so far.

Implant Files Safety

US Regulatory Roundup, November 2018: Press Scrutiny, FDA Reforms And The Midterms

The global investigative journalism spotlight on the medtech space had major impact at the end of November and now underlie discussions of FDA reforms, even if the agency was already working on them. Meanwhile, there was a US midterm election in November. Here's the most popular US regulation and policy stories from last month.

Regulation FDA

As Congress Approves Two-Week CR Deal, Clock Ticking For Permanent Device Tax Repeal In 2018

The medtech industry has been lobbying the US Congress hard to approve a permanent repeal of the device tax this year, but with passage of another continuing resolution bill Thursday, legislators have left themselves just two more weeks in 2018 – until Dec. 21 – to finish up a must-pass spending bill for 2019 that could serve as a vehicle for repeal of the tax.

Legislation Policy

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Deadline For ISO 13485 Survey Extended To Dec. 31

Stakeholders can still fill out a survey that asks for feedback on potential plans to retool international quality systems standard ISO 13485. The deadline for the survey was extended so the International Organization for Standardization (ISO) committee that oversees revisions to ISO 13485 can make a stronger case against opening it up for a rewrite.

International Standards

Compliance 360° Part 14: Leverage FDA Data To Stay In The Agency's Good Graces

This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this fourteenth installment, former FDA investigations branch director Ricki Chase explains how device-makers can leverage publicly available data from the agency to determine where they might fall short when it comes to complying with FDA rules and regulations.

Compliance 360 FDA

Q3 Recalls Snapshot: Recalled Devices Slide In Third Quarter; Software A Nagging Issue

Good news for the medical device industry: After two record-setting quarters, the number of recalled products and device units fell in the third quarter of 2018. Yet device-makers are still having problems with software, which was the leading cause of recalls in Q3. Check out our Q3 recalls infographic.

Recalls Safety

Commercial Explore this Topic

Set Alert for Commercial

Medtech Money Flow: M&A & VC Deals, Dec. 3 - 9, 2018

This edition of Medtech Money Flow rounds up the M&A and venture financing deals, as recorded in our M&A and VC Deal Trackers, from Dec. 3 - 9, 2018.  
M & A Financing Deals

Investors Pump $30M Into Israeli Heart Failure Therapy

WhiteSwell has received $30m in financing to support development of a catheter-based device for treating acute decompensated heart failure. The investment round was led by RA Capital Management and an InCube Ventures syndicate, with participation from other investors.

Cardiology Financing

Execs On The Move: Hill-Rom Appoints Former New CFO, Promotes Two VPs

Medical equipment and technology systems-maker Hill-Rom Holdings taps a former Mallinckrodt financial executive as its new chief financial officer, while promoting new VPs in Front Line Care and Strategy and Investor Relations. More personnel moves from around the medtech industry.

Appointments Commercial

Pear Picks Up Prescription Opioid App Clearance

Novartis subsidiary Sandoz will lead the US launch of Pear Therapeutics' reSET-O prescription-grade mobile app for opioid use disorder in the coming days following US FDA go-ahead.

Digital Health Approvals

QUOTED. Dec. 10, 2018. David Ahn.

The global blood glucose monitoring devices market is expected to exceed $7bn by 2022, driven in large part by the fastest-growing continuous glucose monitoring segment. Sales of the much larger blood glucose meter segment, meanwhile, are expected to drop to $3.7bn in 2022 from nearly $5bn in 2017 amid rising competition from lower-cost manufacturers and tech giants entering this space. But the major blood glucose meter makers are also reinventing themselves by offering smarter technologies. See what David Ahn, an endocrinologist and program director at the Mary and Dick Allen Diabetes Center at the Hoag Hospital in Newport Beach, California said about the issue here.


Commercial Digital Health

Work With Patients To Design Trials For Anti-Hypertensive Devices, FDA Advisors Suggest

FDA is looking forward to reviewing PMAs from several anti-hypertension devices in the coming years – including technologies from Medtronic, ReCor Medical, ROX Medical, and Vascular Dynamics – so the agency convened its Circulatory System Devices Panel on Dec. 5 to get recommendation on pre-market clinical trial design, post-approval study design, indications and labeling for such devices.

Advisory Committees Cardiology

Market Intel: Needle-Free Glucose Monitoring, Digital Solutions Are Game-Changers In Growing Diabetes-Monitoring Market

The global blood glucose monitoring devices market is expected to exceed $7bn by 2022, driven by the smaller, but fastest-growing continuous glucose monitoring (CGM) segment, which is expanding at double-digits. The much bigger blood glucose meter (BGM) segment, meanwhile, is facing increased competition from lower-cost manufacturers, innovative startups and tech giants like Apple that are attracting consumers with smart devices and packaged diabetes management solutions. This first of a two-part series looks more closely at the competitive landscape of the two major product segments – BGM and CGM – with insights from endocrinologists. The second part will focus on the pros and cons of using diabetes management apps and highlights the best diabetes apps.

Diabetic Care Digital Health

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Starts & Stops: Edwards Updates Mitral And Tricuspid Trials

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements from Dec. 3 through Dec. 9, including trial announcements from Edwards Lifesciences, Nemura Medical, Hancock Jaffe, Johnson & Johnson, and more.

Starts & Stops Tracking Trials Clinical Trials

Global Device Approvals, Weekly Snapshot: New Endobronchial Valve, Cell Therapy

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Newly added devices include an endobronchial valve for emphysema approved in the US and an autologous cell therapy for urinary incontinence approved in Japan.

Approvals Innovation

Results Recap: Long-Term Results Support NovoCure's Optune Brain-Cancer Technology

Results Recap is Medtech Insight's exclusive summary of clinical trial results that have been announced or published in the past week, based on information collected by Meddevicetracker. This week's edition, covering the week of Nov. 30 – Dec. 6, includes results of a retrospective post-hoc sub-group analysis of the EF-14 phase III pivotal trial of Novocare's Optune system in newly diagnosed glioblastoma, one-year data from a study of Vieve Medical's Geneveve treatment of mild-to-moderate stress urinary incontinence, and complete results from the Long-Term Treatment Study of NeuroPace's RNS system to treat epileptic seizures.

Tracking Trials Clinical Trials

Work With Patients To Design Trials For Anti-Hypertensive Devices, FDA Advisors Suggest

FDA is looking forward to reviewing PMAs from several anti-hypertension devices in the coming years – including technologies from Medtronic, ReCor Medical, ROX Medical, and Vascular Dynamics – so the agency convened its Circulatory System Devices Panel on Dec. 5 to get recommendation on pre-market clinical trial design, post-approval study design, indications and labeling for such devices.

Advisory Committees Cardiology

Global Device Approvals, Weekly Snapshot: New Shoulder Component, AAA Graft

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Newly added devices include a new LimaCorporate should component, US approval of the Incraft aneurysm stent graft and a first-in-class newborn-screening diagnostic.

Approvals Research & Development

Device Week, Nov. 30, 2018 – Bioprinting Is Moving From Far-Fetched To Reality; ‘Femtech’ Investment Heats Up

In this edition of Device Week, Medtech Insight managing editor Marion Webb discusses the ongoing research that could lead to 3D-printing of human replacement organs and reporter Catherine Longworth highlights the developments in “femtech,” medical technology primarily or exclusively for female patients.

Device Week Innovation

Global Device Approvals, Weekly Snapshot: PMA Drought Continues

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. A electrical stimulator for GI disease is among devices that made the list this week. Also, a drought in original PMAs and panel-track supplements in the US.

Approvals Research & Development
UsernamePublicRestriction

Register

Advertisement