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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

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 Commercial

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 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 Policy

Device Week, Dec. 7, 2018 - FDA Panel Looks At Heart Failure, Hypertension

On this week's podcast, David Filmore talks with Elizabeth Orr and Reed Miller about the recent meeting of the US FDA Circulatory System Devices Panel, where agency advisors addressed a "Breakthrough" heart failure device and discussed the clinical-trial needs for hypertension devices.

Advisory Committees Device Week Cardiology

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Policy & Regulation Explore this Topic

Set Alert for Policy

Cancer IVDs Could See Label Expansions Under New Guidance

US FDA is proposing to allow cancer IVD-makers to label their tests for certain types of cancers and their therapies instead of limiting them to specific drugs and biologics. The agency says the expanded labeling is crucial to giving patients more options and help target treatments.

Regulation Diagnostics In Vitro Diagnostics

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 Legislation

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

FDA Continues Push To Bring Lab-Developed Tests Into The Fold

In a Dec. 6 blog post, US FDA officials continued pressing for a new system of diagnostics regulation that puts laboratory-developed test services (LDTs) on the same footing as IVD test kits, all under a new framework where only about 10% of tests would require pre-market review.

In Vitro Diagnostics Regulation

QUOTED. Dec. 6, 2018. Bram Zuckerman.

The first US FDA device advisory panel to address a product on FDA's Breakthrough Devices program overwhelmingly supported Impulse Dynamics NV's Optimizer Smart system, an implant that delivers cardiac contractility modulation to patients with heart failure. The recommendation came despite panel uncertainty during a Dec. 4 meeting as to whether there was enough trial data to prove safety and effectiveness. See what Bram Zuckerman, the director of FDA's division of cardiovascular devices, said about it here. 

Quoted Advisory Committees

Study Highlights Autoimmune, CTD Issues In Women Who Had Breast Implants

Early results of a new study of 300 women who previously had breast implants, and a review of longer-term follow-up of patients who had their implants removed, found more patients have suffered autoimmune issues and connective tissue disease than have come out in FDA-mandated studies, according to the National Center for Health Research. NCHR was critical of FDA's and industry's approach to post-market surveillance of breast implants.

Safety Post Market Regulation & Studies

CAMD Points To End Of EU Market Surveillance Project: More Scrutiny For Manufacturers Ahead

Market surveillance has historically been too fragmented around Europe, according to critics of the EU system, but the national authorities have been creating a new joint work program and are on the cusp of launching a new initiative.

Medical Device Europe

Commission Addresses Non-EU/EEA Authorities To Set Record Straight On New EU Regs

There are fears that some countries may reject medical devices and IVDs that have been CE marked under the EU medical device directives, even though their registrations may still be valid. The European Commission is now trying to address this.

Medical Device Europe

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

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Reselling Devices: H-Source Adds OEM Devices, Supply-Chain Integration Options To Growing Platform

H-Source, a cloud-based network of health-care organizations who buy and sell unused medical device inventory, has begun adding products from original equipment manufacturers. The rapidly growing company is also adding new features that allow users to integrate their transactions on H-Source into their regular supply-chain management systems.

E-Commerce Business Strategies Cost Effectiveness

Market Snapshot: Vascular Access Site Closure Market Expected To Rise 6.5% By 2022

The global market for vascular access site closure products is expected to reach $1bn in 2022, driven in large part by the rising prevalence of cardiovascular disease, the leading cause of death globally. The most dominant trend in this market is the development of vascular closure devices for larger arteriotomies. Large-bore procedures, such as transcatheter aortic valve replacement (TAVR) and endovascular aneurysm repair, will drive demand for vascular closure devices. Due to complications associated with active vascular closure devices, the use of passive vascular closure devices is on the rise. Check out our infographic for details.

Commercial Cardiovascular

Execs On The Move: New Chiefs At Neurotech, Photocure

An early investor in the Australian neurostimulation and neuro-diagnostic company Neurotech International is now the firm's CEO. And Photocure, focused on photodynamic technology for bladder cancer, hired a new chief executive from Ablynx.

Appointments Commercial

ResMed Continues To Build Digital-Medicine Business With $225M Acquisition Of Propeller Health

Propeller Health bills itself as a digital respiratory therapeutics company, providing a mobile platform that communicates with sensors on patients' inhaler devices to help them manage chronic obstructive pulmonary disease and asthma. This the second major acquisition ResMed has announced in the last month.

M & A Digital Health

QUOTED. Dec. 4, 2018. John Scandurra.

Aria CV hopes to address pulmonary hypertension, a potential devastating condition that currently has few treatments, with a unique balloon device that requires no power supply, battery, pump, or synchronization. See what Aria CEO John Scandurra said about it here.

Quoted Companies

Medtech Money Flow: M&A & VC Deals, Nov. 26-Dec. 2, 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 Nov. 26 - Dec. 2, 2018.     

Financing Deals

Turkish Government Changes Model For Giant Device Tender To Enable Local Company Bids

As the date for multibillion-dollar medical device bidding process for hospitals in Turkey gets closer, the government made an important change, dropping the condition that bids must cover the whole package of requested devices. This opens the way for partial bids that smaller companies might be able to handle.

Turkey Commercial

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

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 Clinical Trials

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

QUOTED. Nov. 21, 2018. Boyle Cheng.

The Center for Surgical Arts in Pittsburgh is amassing big-ticket medical devices to train residents and fellows in a variety of surgical specialties. See what Allegheny Health Network's Boyle Cheng said about the Center here.

Quoted Research & Development

'Where Technology Meets Science': Doctors, Medical Students Take Experimental Medtech For A Spin In Pittsburgh's Center For Surgical Arts

Some big-name device-makers – Medtronic, Stryker, Karl Storz, Siemens and more – are donating expensive capital equipment to the Center for Surgical Arts, a modern teaching lab that boasts 21 bays for training residents and fellows in various types of surgery. The companies are doing this to not only nail down future customers, but to test new devices, as well. The Center also includes a Bose test frame that was used to help clear Alphatec Spine's Solus device with US FDA without a clinical trial. "Those can be multimillion-dollar studies. So, to be able to do that, and to have the FDA feel comfortable with that, is kind of a cool capability," says Dr. Donald Whiting, chair of the Allegheny Health Network Neuroscience Institute.

Research & Development Innovation

Global Device Approvals, Weekly Snapshot: Medtronic, Edwards Wins In Europe

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. CE marks for a Medtronic stent graft and Edwards Lifesciences' TAVR update anchor this week's list.

Approvals Innovation