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Concerns Rise For Notified Bodies Over Potential Reopening Of PIP Case

Medtech notified bodies need to monitor PIP liability issues again as France's top court weighs in. Will it trigger a reopening of the TÜV Rheinland liability case? And what might it mean for notified bodies in general?

Europe Legal Issues Regulation

Market Intel: Insulin Pumps Dominate $7bn-Plus Global Infusion Devices Market

The global infusion drug delivery market continues to be driven by the rising prevalence of chronic disease and associated obesity, coupled with a growing aging population. Technological advancements such as less invasive pumps, needlestick prevention features and miniaturization have also supported the growing demand, but obstacles such as safety and security issues remain. According to a new report by Meddevicetracker, the global market for infusion pumps and disposables will reach $9.9bn by 2022, a CAGR of 6.4% from 2017. This article takes an in-depth look at the overall infusion pumps market, and dives deeper into the three fastest-growing segments – insulin, enteral and disposable pumps – highlighting the key players and competitive landscape.

Metabolic Market Intelligence Commercial

Philips Joins AHA, UPMC To Invest In Heart Disease, Stroke Innovation

Philips has teamed up for the first time with the American Heart Association and the University of Pittsburgh Medical Center to set up a $30m venture capital fund that will invest in start-ups that are developing solutions to combat heart disease and stroke.

Cardiology Neurology Financing

BTG Heads To Panel Next Month For Emphysema Device

A PMA for the PneumRx ELEVAIR endobronchial coil system will be considered by a US FDA advisory panel in June, but there will likely be some questions about the data.

Advisory Committees Approvals Respiratory

Device Week, May 18, 2018 – Medtech’s Next Top Maturity Model, Part 1

On this week's podcast, Shawn M. Schmitt talks about his first story in a multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity, and what it means for the medical device industry. An ongoing US FDA pilot program – which uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) model and method – is discussed.

Device Week Quality Control FDA

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Policy & Regulation Explore this Topic

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'Program Alignment' Turns 1: FDA Wants To Train Investigators On Innovative Tech As Part Of Its Inspection Scheme – But Will It Be A Cakewalk?

At the one-year anniversary of "program alignment" – US FDA's ambitious reorganization of its inspectional body – the agency is pushing hard to train its investigators on an array of medtech products. In that spirit, FDA has asked manufacturers to willingly open their doors to its investigators so they can learn more about the type of devices the firms are making, says Blake Bevill, a program division director for program alignment. Industry group AdvaMed and health-care organization Medical Alley Association are also getting in on the action by helping investigators learn about an array of topics, including software, electrical engineering, validation and design.

FDA Enforcement Compliance

FDA Urges Caution in Some Neurovascular Stent Use

US FDA has issued new guidelines to providers because some patients experienced strokes or died after being treated for unruptured brain aneurysms with some neurovascular stents.

Medical Device Neurology Safety

Bills Supporting Device Opioid Alternatives Advance In House

The House Energy and Commerce Committee approved four opioid crisis-related bills that call for US FDA meetings and consideration of streamlined pathways for medtech alternatives to opioids, and for a report and action by the US Medicare agency on overcoming payment challenges to device pain control products.

Legislation Policy

New Dutch Chair For Pivotal EU Medtech Authority Group

The new executive group chair of the Competent Authorities for Medical Devices will help steer EU medtech through one of the trickiest times in its regulatory history, as the key national authorities group loses its UK lead.

Medical Device Europe

Warning Letter Roundup & Recap – May 17, 2018

German maker of the Twion Power Push-Rim Power Drive System cited for quality systems violations; RADLogics was marketing its AlphaPoint software without pre-market approval or clearance from US FDA.

Device Warning Letters FDA

QUOTED. May 17, 2018. Renzo Marchini & Robert Fett.

The May 25 deadline for the EU's General Data Protection Regulation is rapidly approaching. See what attorneys Renzo Marchini and Robert Fett have to say about some of the considerations for medtech companies.

Cybersecurity Digital Health

Industry Gives US Trade Rep 12 Reasons Why Tariffs on Chinese Medtech Imports Are A Bad Idea

The US Trade Representative office's decision in March to include devices, imaging machines and diagnostics on a list of Chinese imports destined for a 25% tariff has riled up the industry. A half-dozen medtech organizations protested the move in comments and testimony this week, supplying USTR with 12 reasons why the tariffs are a very bad idea.

Trade Policy

No New Regulations Needed For Third-Party Servicers Of Devices, FDA Says

There is “not sufficient evidence” of a widespread public health concern relating to servicing of devices, including by third-parties, according to an FDA report; the agency sees no immediate needs to issue new regulatory requirements for the third-party servicers. The agency also intends to issue guidance to help clarify the difference between “servicing” and “remanufacturing."

Diagnostic Imaging Quality

Quality Control & Compliance Explore this Topic

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US FDA Finds Ongoing CAPA Issues In Zimmer Plant Reinspection

A follow-up inspection evaluating Zimmer Biomet’s progress in remediating issues documented in a 2016 FDA Form-483 uncovered 11 observations, eight of them repeats.

Quality Control Orthopedics

UPDATED: 10 Things You Need To Know About FDA's 'Program Alignment' Inspectional Reorg

Now that US FDA's "program alignment" inspection paradigm is in full swing, does your device firm know where to send an FDA-483 response? How to alert the agency about a recall? Who to contact if there is a problem with an FDA investigator? If not, then check out the answers to those questions – and seven more – in this updated feature article.

FDA Enforcement

Q1 Recalls Snapshot: Recalled Units Skyrocket 457%; Largest Quarterly Number In 13 Years

More medical devices were recalled by manufacturers in the first quarter of 2018 than in any quarter since at least 2005, with 343 initiated. Moreover, there were 208.4 million units recalled in Q1 '18 – more units than in all of 2017. Check out our Q1 recalls infographic.

Recalls Safety

Commercial Explore this Topic

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Turkey's Alvimedica Ramps Up Global Expansion In Interventional Cardio

Turkish interventional cardiology solutions firm Alvimedica is set to expand significantly its manufacturing capacity in a bid to further strengthen its position in the global heart stents and valves sectors. The company has ring-fenced around $370m to build a new facility, and its investment will be further supported by incentives from the Turkish government.

Cardiology Companies Commercial

QUOTED. May 15, 2018. Thomas Rodgers.

Liquid biopsy marquee player Grail Inc. has reported results of several proof-of-concept approaches to cancer screening that achieved high specificity, and a handful of smaller-scale cancer-specific tests are already available. See what Thomas Rodgers of Grail investor McKesson Ventures had to say about it here.

Quoted Commercial

Medtech Money Flow: Weekly M&A and VC Deals, May 7-13, 2018

In this weekly feature, Medtech Insight presents a roundup of the previous week's M&A deals and venture financing rounds recorded in our M&A and VC Deal Trackers. This edition presents the transactions announced May 7-13, 2018.

Commercial Deals

QUOTED. May 14, 2018. Omar Ishrak.

Company stock will make up the "vast majority" of Mike Weinstein's compensation for being Medtronic's new senior VP of strategy. CEO Omar Ishrak said Medtronic's evolving executive compensation policies are an element of the firm's efforts to improve value to shareholders. See what Ishrak said about it here.

Quoted Appointments

Market Intel: Liquid Biopsies For Cancer Screening – Far From Reach Or Close At Hand?

While liquid biopsy is becoming routine for cancer treatment stratification and monitoring, using blood tests to screen for early cancer in asymptomatic people remains a tantalizing target. Some question how practical such a test could be but several companies are already en route - some further down the road than others - to achieve this goal. Illumina spin-out Grail is one of these companies and while it is not alone, in a field where size matters, it may have an advantage. This article delves deeper into how these different technologies work and when they could reach the market.

In Vitro Diagnostics Cancer

M&A Analysis: Volume Shrinks In April But Value Inflated By Big Acquisitions

Medtech M&A activity dipped in April from last month but brought in a number of high-value acquisitions. Highlights included Fresenius, the world's largest dialysis firm, selling its majority shareholding in Sound Inpatient Physicians Holdings for $2.15bn to investment firm Summit Partners. 

Deals M & A

Pacts In Medtech, March/April 2018

Derived from Strategic Transactions, Informa’s premium source for tracking life-sciences deals, the bimonthly Pacts In Medtech highlights notable technology alliances, R&D partnerships and commercial collaborations. In this edition, we look at industry pacts that were sealed in March and April 2018.

Pacts in Medtech Deals

Clinical R&D Explore this Topic

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HRS 2018: CABANA Misses Endpoint, Leaving Questions About AF Ablation

The long-awaited results of the CABANA trial, a large randomized study comparing ablation to drug therapy as a first-line treatment for atrial fibrillation, were presented at the Heart Rhythm Society conference in Boston on May 10. The trial missed its primary endpoint in the "intent to treat" analysis, but showed a significant benefit for ablation in the "as-treated" analysis.

Cardiovascular Cardiology Clinical Trials

QUOTED. May 18, 2018. William Abraham.

Results of a study showed that Impulse Dynamics' Optimizer device significantly improved exercise tolerance and quality of life in certain heart-failure patients. See what principal investigator (and cardiologist) William Abraham of Ohio State University said about those patients here.

Quoted Clinical Trials

HRS 2018: Optimizer Cardiac Contractility Device Helps Subset Of Heart-Failure Patients

The FIX-HF-5C trial, a subgroup study derived from the FIX-HF-5 pivotal trial, shows that the Impulse Dynamics Optimizer cardiac contractility modulation device significantly improved exercise tolerance and quality of life in certain heart-failure patients. Results of the trial were presented at the Heart Rhythm Society conference in Boston. Impulse Dynamics expects to file the final PMA module for US FDA for Optimizer in June.

Clinical Trials Approvals

J&J's EmboTrap Clot Retriever Gets US Green Light

Johnson & Johnson has added the Embotrap clot retrieval device to its US offering after the product got FDA clearance. It will compete with Medtronic's Solitaire and Stryker's Trevo, which are already on the US market.

Neurology Approvals

iSTAR's Glaucoma Micro Device Shines In Early Follow-Up

iSTAR Medical reported six-month clinical trial data supporting its latest micro-invasive glaucoma surgery device, MINIject.

Ophthalmology Innovation

Device Debut: Oncimmune Pushes Liver Cancer Test In The US

Oncimmune has expanded its offering in the US with the launch of a blood-based liver cancer test, the second product to emerge from its EarlyCDT platform.

Approvals Research & Development

Starts & Stops: May 7-13, 2018

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements made between May 7 and 13, 2018, including announcements from BioCardia, Akili Interactive Labs, Arch Therapeutics, and Acutus Medical.

Starts & Stops Clinical Trials