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Featured Stories


UK Brexit White Paper Would Keep Medtech Regulatory System – And Testing Just Once – Intact

It looks as if the EU medtech regulatory system could survive intact in the UK, given terms of the UK blueprint for its future relationship with the EU after separation. But a storm of controversy must be navigated first.

Brexit Regulation United Kingdom

VC Deals Analysis: Mega-Rounds Abound, As H1 Deal Value Rockets Past $4bn

A quartet of mega-rounds in June closed off what has been the most successful first-half since 2014, with an impressive $4.7bn of private venture funds raised in total. Digital health is one area that is evidently rising in investor popularity and potentially helping to drive these mega-rounds.

Deals Financing StartUps and SMEs

Message To US Congress: Know What Cybersecurity Tools You Have, Share What You Know, Untie Our Hands

Responding to US lawmakers on how to tackle cybersecurity threats to medical devices and the health-care system, device firms, hospitals, provider groups and other stakeholders listed recommendations on creating inventories, sharing information and amending laws.

Cybersecurity Digital Health Legislation

How Kavanaugh High Court Pick Could Increase IUD Sales

A look at what impacts a changed court could have on abortion rights, and related IUD products that device companies Bayer and Allergan make and sell, plus a peek at new contraceptive products on the horizon.

The second of a multi-part Medtech Insight feature series on what a more conservative Supreme Court could mean for future court decisions that impact the medical device industry.

Legal Issues Policy United States

Device Week, July 13, 2018 – Medtech’s Next Top Maturity Model, Part 3

Part 3 of Medtech Insight’s feature series on the appraisal of manufacturing capability and maturity – “Medtech’s Next Top Maturity Model” – is discussed on this week’s podcast. Author Shawn M. Schmitt gives details on how Baxter Healthcare, Edwards Lifesciences and other firms weathered their appraisals using the Capability Maturity Model Integration (CMMI) model and method.

Device Week FDA Manufacturing

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Getting The Words Right: Device Documentation And Translation in Asia

Oracle Health Sciences

Although the medical device sector has seen increasing harmonization of regulations both globally and regionally, market-entry requirements in Asia still retain a significant degree of localization, particularly as they relate to product labeling and documentation.

Download the article to learn more about the challenges and potential rewards of device documentation and translation in Asia.

The article reviews:

  • New regulatory reforms and their impact
  • The role and limitations of localizing software
  • Opportunities to translate for growth

Read Article

Policy & Regulation Explore this Topic

Set Alert for Policy

CMS Proposes To Cover More Telehealth, And Address Imaging, Lab Pay Matters

The US Medicare agency has proposed several changes to the status quo in its planned 2019 Medicare physician fee schedule and clinical laboratory fee schedule that will impact reimbursements for telehealth services, the advanced imaging industry and clinical laboratories.

Reimbursement Regulation United States

Localism & Local Languages Make For Better Medtech Business In Russia And EAEU

The probability of a postponed entry-in-force of the single Eurasian Economic Union system of medtech regulation has increased over the course of this year, according to speakers at the 2018 Informa KNect 365 Medtech Summit. But the drive for stronger local medtech industries continues, leaving foreign manufacturers with market-access problems to address.

EAEU Regulation Russian Federation

QUOTED. July 13, 2018. Harriet Marsden.

A crackdown on surgical mesh procedures in the UK is renewing scrutiny of the EU regulatory system in some quarters. Here's a snippet from an unsparing piece from the UK-based news service The Indepedent.
Quoted Medical Device

US Durable Equipment Bidding Restrictions Will Relax, Temporarily, In January

Durable medical equipment suppliers will have the flexibility to provide products to any Medicare beneficiaries without having to win a competitive bidding contract beginning Jan. 1. That state-of-play will last until CMS reinitiates the paused bidding program currently undergoing reforms.

Medicare Reimbursement

UK HealthTech Ready To Take The Digital Challenge With Focused Actions

Digital tools and maximizing the data derived from them will influence the delivery of health care in ways and to extents yet unknown. Andrew Davies, market access director for UK industry group ABHI, explains the industry's planning around this, and calls for a rethink on innovation market access structures, which are still failing to meet industry's needs.

Market Access Digital Health

'A Criminally Negligent Medical Device Regulatory System': UK Mesh News Provokes Outrage

The EU medtech regulatory system is coming under fire again in the UK, being blamed for the vaginal surgical mesh scandal as action is taken to limit procedures. But this is a global problem.

Medical Device Europe

Latest UK Political Shenanigans: What Medtech Needs To Know

Theresa May finally made a Brexit plan, but its effects have been explosive. One consequence: the UK has a new health secretary. What do the latest cabinet changes mean for health products, and why is certainty still so far away?

Medical Device Europe

Hungarian Court Decision Threatens Unified Patent Court Viability

Hungary has decided that Europe’s forthcoming Unified Patent Court Agreement is not compatible with its constitution. It will now be more important than ever to keep a close watch for possible new constitutional complaints in other countries.

Intellectual Property Hungary

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Inside Toyota's 'Cult': Car-Maker's Quality VP Tells Device-Makers How They Can Adopt 4-Pronged Quality Strategy

Toyota Motor North America's Kristen Tabar told a roomful of medical device quality and regulatory professionals at a Case for Quality forum that they can infuse quality concepts into every nook and cranny of their firms by adopting the car-maker's quality strategy of reflection, education, celebration and planning. "I don’t want to make it sound like it’s sort of cult-y, but it’s kind of cult-y," Tabar quipped.

Quality Safety

With New Initiatives, Case For Quality Embarks On Mission To Create 'Safe Space,' Engage CEOs, #makeCAPAcool

Quality and regulatory officials from Medtronic, Hologic, Baxter Healthcare and Boston Scientific – among others – are working with the joint US FDA/MDIC Case for Quality to fully realize a two-year strategic plan that targets corrective and preventive action (CAPA), CEO engagement in quality activities, career paths in device quality, and more.

Quality Control Manufacturing

New 'Quality Culture Playbook' Aims To Drive An Organization-Wide Quality Mindset, AdvaMed Says

The device industry advocacy group is putting the final touches on its free playbook, which draws from proven quality culture work conducted at high-profile companies like Medtronic and Covidien, among others.

Quality Quality Control

Commercial Explore this Topic

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Medtech Money Flow: Weekly M&A And VC Deals, July 2-8, 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 July 2-8, 2018.

Deals M & A Financing

ResMed, Verily Connect To Form Sleep Apnea JV

Sleep disorder therapy specialist ResMed and Alphabet's health unit Verily are combining their expertise to form a new joint venture focused on developing solutions that will enable health care providers to better diagnose and manage sleep apnea and other breathing-related sleep problems.

Commercial Respiratory

Biodesix Cites 'Natural Fit' Of Acquired Integrated Diagnostics Lung Cancer Test

Biodesix has acquired Integrated Diagnostics for an undisclosed sum to add the XL2 lung-cancer test to its molecular diagnostics line-up and to acquire technology and expertise that can improve its biopharma business.

M & A Deals

QUOTED. July 12, 2018. Peter Pronovost.

Medtronic's agreement to provide continuous glucose monitor and insulin pump systems to UnitedHealthcare members improved patient-outcomes in the first year, according to an analysis. See what Peter Pronovost, the insurance company's chief medical officer, said about it here.

Quoted Commercial

Pacts in Medtech, May/June 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 May and June 2018.

Pacts in Medtech Digital Health

Medtronic and UnitedHealthcare Encouraged By First-Year Results From Value-Based Agreement

Medtronic and UnitedHealthcare have evidence that their year-old partnership is improving  health outcomes in diabetes patients that require intensive insulin delivery. An analysis of more than 6,000 UnitedHealthcare members with diabetes who used Medtronic's MiniMed 630G and previous generation insulin pumps between July 2016 and July 2017 showed 27% fewer preventable hospital admissions compared to plan-participants who were using multiple daily injections of insulin.

Commercial Deals

QUOTED. July 6, 2018. Gerard Criner.

Almost a decade after US FDA first rejected it, the agency approved Pulmonx Corp.'s Zephyr endobronchial valve system based on clinical results from the company's Liberate study and two other multicenter randomized control trials. See what Liberate lead investigator Gerard Criner said about the device here.

Quoted Approvals

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

US Device Approvals Q2 Snapshot: Cook Clearances Continue; Novel Device Approvals Pick Up

Cook Group maintained strong 510(k) clearance numbers, while US FDA novel-device approvals picked up in Q2 after a slower first quarter. Here's an infographic to spotlight US device approval trends during the second quarter, April through June.

Approvals Research & Development Innovation

QUOTED. July 12, 2018. Peter Pronovost.

Medtronic's agreement to provide continuous glucose monitor and insulin pump systems to UnitedHealthcare members improved patient-outcomes in the first year, according to an analysis. See what Peter Pronovost, the insurance company's chief medical officer, said about it here.

Quoted Commercial

Medtronic and UnitedHealthcare Encouraged By First-Year Results From Value-Based Agreement

Medtronic and UnitedHealthcare have evidence that their year-old partnership is improving  health outcomes in diabetes patients that require intensive insulin delivery. An analysis of more than 6,000 UnitedHealthcare members with diabetes who used Medtronic's MiniMed 630G and previous generation insulin pumps between July 2016 and July 2017 showed 27% fewer preventable hospital admissions compared to plan-participants who were using multiple daily injections of insulin.

Commercial Deals

Global Device Approvals Q2 Shapshot: Coronary Devices Abound

The second quarter of 2018 brought 62 approvals from outside the US, including 46 in Europe, according to Medtech Insight's Approvals Tracker. Among those approvals, 14 were for devices to treat coronary artery disease, and the second most-common indications were obesity and soft-tissue repair. Outside of Europe, Japan had the most non-US approvals in the quarter with five.

Approvals Clinical Trials

Global Device Approvals, Weekly Snapshot: July 2-8, 2018

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

Approvals Neurology

Starts & Stops: July 2-8, 2018

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements made between July 2 and July 8, 2018, including announcements from Mainstay Medical, ReCor Medical, Otsuka Holdings, Terumo, MagForce, Bently Innomed, and inner Mongolia Furui Medical Science.

Starts & Stops Research & Development

Device Week, July 6, 2018 – Clinical Data Presentations At ADA; Big Deals From GE, Novartis And Bio-Techne

In this edition of our weekly podcast, Medtech Insight editor Marion Webb reports on the American Diabetes Association conference in Orlando, Fla., and editor Reed Miller runs down the latest corporate restructuring news, including GE's decision to spin off GE Healthcare and Novartis giving-up on Alcon.

Device Week Clinical Trials
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