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HRS 2018 Wrap-Up: Tendril Lead Failures; Metaanalysis Of Contact-Force Catheter; LuxCath's OmniView; More Micra Results

The 2018 Heart Rhythm Society scientific sessions in Boston covered a variety of presentations of new electrophysiology clinical data, including a report on the failure of St. Jude's Tendril leads, a meta-analysis of contact-force catheters for atrial-fibrillation ablation, and new data on Medtronic's Micra leadless pacemaker.

Cardiology Clinical Trials Innovation

Despite Only Two Parallel Review Success Stories, CMS Touts Better Coordination

While only two devices have received approval and a national coverage determination through US FDA/CMS' parallel review program, a top CMS official says industry needs to look beyond just the numbers. Instead, she says the parallel review program is part of a sea-change that has allowed for better communication between CMS, FDA and sponsors.

Reimbursement Market Access Policy

Who Can Use MDR's Four-Year Derogation Extension? Notified Bodies Try To Clarify

Many companies are pinning hopes on being able to use the EU Medical Device Regulation's four-year extension period for products CE marked under the current directives. But with a lack of clarity from the policymakers so far, TEAM-NB has stepped in.

EuroPCR 2018: Robocath Eyes December CE Mark For R-One Positive Pre-Clin Data

Robocath is planning a year-end market launch of its flagship R-One robotic catheterization system after the preclinical trial of R-One hit all primary endpoints. If the product is CE-marked in December as anticipated, it will be a rival to Corindus Vascular's CorPath, which is currently the only robotic-assisted system in the market for interventional cardiology. Robocath announced the preclinical data at EuroPCR in Paris, being held this week until May 25.

Cardiology Cardiovascular Clinical Trials

QUOTED. May 22, 2018. Tamara Syrek Jensen.

US FDA and the Centers for Medicare and Medicaid Services is working on a joint medical device parallel review pilot program – and now CMS is working with the National Institutes of Health (NIH), too. See what CMS' Tamara Syrek Jensen said about it here.

Quoted Reimbursement Market Access

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Policy & Regulation Explore this Topic

Set Alert for Policy

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

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

House Panel Approves Boosts For FDA Digital Health Plan, Quality Medtech Manufacturing

The US House Appropriations Committee in 2019 wants to give FDA an additional $40m to boost its digital health oversight, $12m more to “create a competitive marketplace for device quality,” and instructs the agency to keep working with Congress on a new laboratory-developed test regulatory path.

Digital Health Legislation

CMS Weighs Whether Volume Requirements Are Needed For TAVR

The US agency will convene advisors this summer to reassess whether hospital and practitioner procedure volume requirements, currently a prerequisite for running a Medicare-covered transcatheter aortic heart valve replacement program, are warranted.

Reimbursement Market Access

Warning Letter Roundup & Recap – May 22, 2018

US FDA did not release any device-related warning letters the week of May 22.

Device Warning Letters FDA

QUOTED. May 21, 2018. Michael Burgess.

H.R. 5806 – the "21st Century Tools for Pain and Addiction Treatment" – passed the US Senate on May 17. It calls for a public meeting and guidances to streamline regulatory passage of opioid medical products, including devices. See what the bill's cosponsor, US Rep. Michael Burgess, said about it here.

Quoted Legislation

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

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

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

'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

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

Commercial Explore this Topic

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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

SetPoint Taps Intersect's Former BD Exec To Head Commercial Ops

Neuromodulation technology specialist SetPoint Medical has appointed Ankit Shah, whose track record include stints at Intersect ENT and Medtronic, as head of commercialization and marketing.

Inflammation Appointments

Zimmer Biomet Calls Out To EMEA Ortho-Focused Digital Innovators

Zimmer Biomet is offering a €25,000 cash prize to the winner of its second Connected Health Innovation Award, which is looking for a digital technology that can improve patient outcomes, as well as save costs, in musculoskeletal health care.

Orthopedics Commercial

Medtech Money Flow: Weekly M&A and VC Deals, May 14-20, 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 14-20, 2018.

M & A Financing

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

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

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

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

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 Research & Development

Starts & Stops: May 14-20, 2018

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements made between May 14-20, 2018, including announcements from Helius Medical, Altair, EP Dynamics and Abiomed.

Starts & Stops Clinical Trials

Global Device Approvals, Weekly Snapshot: May 14-20, 2018

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker.

Approvals Innovation

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

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

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