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Featured Stories


ReCor Deal Underscores RDN Revival – But Also Reason For Backing Medtech?

Certain VCs are becoming reluctant to invest in medtech, citing difficulties such as a shrinking pool of buyers and increasing regulatory challenges. But Sofinnova Partners has successfully sold a medical device portfolio company – and one that is in a difficult field like renal denervation, no less – to a Japanese buyer. Antoine Papiernik, managing partner at the French VC, explains how persevering with a renal denervation technology paid-off and gives his perspective on whether medtech is still a space worth investing in.

Commercial Deals Financing

Who Is Responsible? Congressional Cybersecurity Inquiry Reveals Manufacturer, Provider Rift

Hospitals and clinicians are pushing back against any assertion that they share equal responsibility with product manufacturers for cybersecurity of legacy connected medical devices. Manufacturers should be required to bear more responsibility, health-care provider groups told US House lawmakers. Device-makers, however, argue it is unreasonable to expect them to support security on their products indefinitely.

Cybersecurity Digital Health Legislation

European Parliament To Commission: How Will New Regulations Be Ready On Time?

Little has been forthcoming from the European Commission about actions it is taking to get the new European regulatory framework for medical devices and IVDs ready on time. Now the European Parliament wants some answers.

Europe Medical Device Policy

Compliance Corner: Follow These 4 Tips From FDA's Maisel For A Better Pre-Market Experience

Bill Maisel – the director of the Office of Device Evaluation within US FDA's Center for Devices and Radiological Health (among other titles) – says there are four things device-makers should do to make sure they succeed during the product-review process.

Compliance Corner FDA Medical Device

Open Payments: Zimmer, Medtronic Top List Of Spenders

Major medical device companies paid almost $1bn in consulting fees, royalties, research costs and other expenses to physicians in 2017, the most recent data release from the US Open Payments database shows. Zimmer Biomet reported the highest spending on general physician payments, while Roche and Medtronic topped the list of research spending.

Clinical Trials Compliance Policy

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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

Do What You Can, And Do It Now: MDR/IVDR Experts Advise Industry To Move Quickly

There are hurdles to compliance with the EU Medical Device and IVD Regulations –  but companies must jump them now.  A look at why it's time for manufacturers to throw themselves into MDR/IVDR compliance, even if they will sometimes need follow their instinct rather than formal guidance.

Europe Medical Device Policy

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

MassMEDIC Taps Device News Publisher As New Prez

The Massachusetts-focused device industry trade group has appointed journalist Brian Johnson as its new president, replacing long-time leader Tom Sommer.

State News Policy

Medtech Suppliers Still Out Of Pocket As Turkish Hospital Debt Trundles On

Even though the Turkish government has settled some of the sizeable debt owed by hospitals to medical device and pharmaceutical suppliers, industry continues to be disgruntled over not being remunerated for the full amount owed and there continues to be wrangling over how the situation should be resolved.

Turkey Market Access

EU's New MDR/IVDR Governance Group: What's At The Top Of Its Agenda?

Precious few details are available on the readiness of necessary structures and documents to support the EU's new Medical Device and IVD Regulations. But the current agenda of the Medical Device Coordination Group gives some insight.

Medical Device Europe

QUOTED. July 16, 2018. Seema Verma.

Proposals for the 2019 Medicare physician fee schedule and clinical laboratory fee schedule (CLFS) released July 12 include reforms designed to relax reporting requirements for providers of health services, and take advantage of emerging telemedicine technologies. See what US Centers for Medicare and Medicaid Services Administrator Seema Verma said about it here.

Quoted Reimbursement

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

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

Quality Control & Compliance Explore this Topic

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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

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

Commercial Explore this Topic

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Medtech Money Flow: Weekly M&A And VC Deals, July 9-15, 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 9-15, 2018.
M & A Financing Deals

QUOTED. July 17, 2018. David Brunel.

Biodesix Inc. is acquiring Integrated Diagnostics Inc. for both its flagship XL2 lung-cancer test and to upgrade its ability to develop new pharma companion diagnostics. See what Biodesix CEO David Brunel said about it here.

Quoted M & A

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

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

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Starts & Stops: July 9-15, 2018

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements made between July 9 and July 15, 2018, including announcements from Rex Bionics, Admedus, Osiris Therapeutics, Sanuwave, Abbott, and Biotronik.

Starts & Stops Clinical Trials Research & Development

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

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

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
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