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Conformity And Confidence: US FDA Seeks To Build Trust In Pre-Market Standards Declarations With ASCA Pilot

FDA hopes the Accreditation Scheme for Conformity Assessment pilot will make it easier to trust the declarations of conformity to standards that are made by device-makers in pre-market submissions, rather than having to ask a lot of time-consuming questions. ASCA, included in the latest FDA user-fee agreement, also has important implications for the agency's global harmonization efforts. But many questions remain about its value and viability; they were on display at a recent two-day workshop at the agency's headquarters.

Standards Regulation International

Exec Chat: Philips' Connected Care & Health Informatics CEO On IT's Role In Tackling Health-Care Demands

The role of digital technologies in enabling health-care providers to meet rising patient demands and overcome challenges is being increasingly recognized. Yet the health-care sector continues to lag behind other industries in adopting these technologies. CEO of Philips' Connected Care & Health Informatics businesses, Carla Kriwet, tells Medtech Insight what the group has been investing in and where it is innovating to accelerate this digital revolution in health care, and how it is staying ahead of new competition from the ICT sector in this digital health game.

Digital Health Exec Chat Companies

UK Notified Body BSI Sets Out Clear Post-Brexit Paths As It Goes Dutch

BSI tackles Brexit issues head-on with aim to allay fears and bring clarity while UK regulator, MHRA, remains reticent to do so. Its messages are relevant for all doing business in the UK

Brexit Europe Regulation

EuroPCR 2018: Several Studies Add Insight To Best Approach To Stable Coronary Disease, Utility Of FFR

New clinical data presented at the EuroPCR conference in Paris, including new data from ORBITA, suggest that fractional flow reserve/ instant wave-free ratio-guided percutaneous coronary intervention may produce better long-term outcomes than PCI guided by angiography in terms of mortality, restenosis and stent thrombosis.

Clinical Trials Research & Development Innovation

Device Week, May 24, 2018 – Medtech’s Next Top Maturity Model, Part 2

On this week’s podcast, part 2 of our multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity – “Medtech’s Next Top Maturity Model” – is discussed. Author Shawn M. Schmitt explains what happens when a device-maker is appraised using the Capability Maturity Model Integration (CMMI) model and method, from the first intake calls to the last day of the assessment, when the final appraisal results are given to a firm.

Device Week FDA Manufacturing

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New MDIC CEO Talks NEST, Case For Quality, CMS, And More

Two months into the job, Medical Device Innovation Consortium CEO Pamela Goldberg talks about the organization's work running the NEST Coordinating Center, its efforts to engage the Medicare agency, early feasibility studies and its work with US FDA on Case for Quality.

Regulation Quality Clinical Trials

MDR/IVDR Survey: Most Manufacturers Ready To Yank Some Legacy Products From EU Market; Hiring Up At Firms

The impending implementation of the EU's new Medical Device and IVD Regulations will cause most firms to pull select legacy devices and in vitro diagnostics from the EU market, a survey of 169 quality and/or regulatory professionals finds. The survey also revealed that companies are in hiring mode as the compliance dates for both regulations approach. Quality and regulatory officials from Abbott Laboratories and Meridian Bioscience weigh in.

Policy Regulation Europe

QUOTED. May 25, 2018. Pamela Goldberg.

The Medical Device Innovation Consortium has formed a strong bond with US FDA over its joint Case for Quality initiative. See what new MDIC CEO Pamela Goldberg said about the group's ongoing search for quality here.

Quoted Regulation

Industry Says No To Australian Approval Process For Personalized Devices

Respondents to a consultation by the Therapeutic Goods Administration on how to adequately regulate personalized medical devices are against the proposed introduction of an application and approval process. But they do favor other proposals that would bolster the rules, particularly for 3D-printed products.

Policy & Regulation Australia

High Court Won’t Take Up Off-Label Case; Other FCA Issues On Docket

While the Supreme Court announced this week that it won’t hear a case related to off-label billings, other False Claims Act-related suits may still be on the docket.

Legal Issues Compliance

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

Quality Control & Compliance Explore this Topic

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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

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

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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 Medical Device

Diabetes, Neuro And Pain Franchises Propel Medtronic To A Strong Finish

Medtech's number one player Medtronic reported solid fourth-quarter results, beating market analysts' forecasts and wrapping up a strong fiscal year 2018. Star performers in the final quarter were its diabetes and restorative therapies businesses.

Sales & Earnings Companies

23andMe Sues Ancestry Over Genetic Testing Patent

Direct-to-consumer genetic testing company 23andMe has filed suit against competitor Ancestry.com, alleging that the AncestryDNA kit infringes on 23andMe’s patent. The company further alleges that Ancestry.com is violating laws against false advertising.

Intellectual Property Legal Issues

Varian Stands Firm Against Rival Bid For SirTex; What Next If It All Falls Down?

Varian Medical Systems' proposed $1.3bn deal to acquire SirTex Medical is officially in jeopardy after China's CDH Investments formalized its rival bid to snatch away the Australian interventional oncology firm. Should the deal fall through, what would Varian's next steps be?

Cancer M & A

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

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

Clinical R&D Explore this Topic

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EuroPCR 2018: Abbott's Tendyne Mitral Valve Shows Early Promise

Early data from Abbott's CE mark study of its mitral valve replacement technology Tendyne shows the device's potential in reducing mitral regurgitation in severe mitral regurgitation patients.

Cardiology Cardiovascular Clinical Trials

QUOTED. May 24, 2018. John Mandrola.

Single-center data presented at the Heart Rhythm Society annual meeting in Boston raised questions about failure rates for Abbott Laboratories's Tendril pacemaker leads. See what Baptist Health electrophysiologist John Mandrola said about it here.

Cardiology Clinical Trials

EuroPCR 2018: Medtronic RDN Rises Out Of Ashes With Positive SPYRAL Data

Medtronic looks to be back on track with its renal denervation plans, after announcing its Symplicity Spyral system got off to a good start with positive six-month results in the SPYRAL HTN-ON MED pilot study. The data, presented at EuroPCR 2018 in Paris, showed that Symplicity Spyral was able to reduce blood pressure significantly in hypertensive patients prescribed anti-hypertension medications, with no major adverse safety events out to six months.

Cardiology Renal

EuroPCR 2018: Real-World TAVR Data Show Consistent Performance With Edwards, Abbott, And Medtronic's Systems

New real-world data on Edward Lifesciences real-world data for its transcatheter aortic valve replacement Sapien 3 valve are among the highlights from the early Hot Line/Late-Breaking Trial sessions at the EuroPCR conference in Paris.

Clinical Trials Innovation

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

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

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
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