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Exec Chat: KCI CEO Andrew Eckert Forsees Big Year For Wound-Care Company

Since selling its LifeCell aesthetic and surgical products business to Allergan in early 2017, Acelity has refocused its commercial efforts, and its name, on the KCI wound-care business, with significant investments in medical education, clinical studies and R&D in that sector, as well as the recent acquisition of UK-based Crawford Healthcare.

Exec Chat Innovation Research & Development

Compliance Corner: FDA's Boyd Gives 4 Pointers For Engaging With The Agency Post-Inspection

Sean Boyd – deputy director for regulatory affairs for the Office of Compliance within US FDA's device center – wants device-makers to take a few steps to ensure that problems identified by investigators during an inspection are adequately addressed.

Compliance Corner Compliance Quality Control

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

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

FDA Panel To Ponder Down-Classifying HIV Tests

US FDA's Blood Products Advisory Committee will consider the agency's proposal to ease regulations on some HIV tests. The agency hopes a streamlined approval process would encourage HIV test development, and ultimately make routine testing for the virus more accessible.

Advisory Committees Diagnostics FDA

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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

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

Switzerland Overhauls Export Certificate Application System

Swissmedic will soon replace its paper-based system for applying for export and manufacturing certificates with an electronic submissions portal.

Trade Policy & Regulation Switzerland

International Regulators Target Country-Specific Labeling Requirements

Proposed guidance from the International Medical Device Regulators Forum explains how to label medical devices, IVDs and medical software.

Policy & Regulation International

QUOTED. July 19, 2018. Robert Dalrymple.

Robert Dalrymple, chief information security officer at the Montefiore Medical Center in Bronx, NY, says a significant problem for hospitals is trying to build the cost of medical device cybersecurity maintenance into their budgets. See what he told US lawmakers here.

Quoted Cybersecurity

Data Control Key In Applying Electronic Health Records As Clinical Trial Tool, FDA Says

Newly finalized guidance from US FDA details the agency's considerations for device and drug sponsors to rely on electronic health records as a clinical trial data source.

Clinical Trials Regulation

CMS To Remove Quality Measures For Breast Cancer Biopsies, Some CABG Procedures And More

As part of its proposed 2019 physician fee schedule and Quality Payment Program, the US Medicare agency plans to remove certain quality measures, including for some coronary artery bypass grafts and pre-operative breast cancer biopsies that medical societies advised providers no longer need to report as QPP Merit-Based Incentive Payment program measures.

Reimbursement United States

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

QUOTED. July 18, 2018. Bill Maisel.

When it comes to getting novel medical devices to market, Bill Maisel knows that time is money. Maisel, director of the Office of Device Evaluation within US FDA's Center for Devices and Radiological Health, routinely discusses the "importance of time" with ODE reviewers. See what he said here.

Quoted FDA

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

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

Bill Maisel – 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

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

Commercial Explore this Topic

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Diabetes Firm CeQur Gains J&J's Calibra Wearable Insulin Patch

With Johnson & Johnson bowing out of the diabetes device market, US firm CeQur has benefited from by securing assets from the health-care giant's Calibra Medical insulin delivery device business.

M & A Deals Diabetic Care

Nevro May Lose Pain-Stim Patent Case Against Boston Scientific

A California judge has issued a tentative ruling favoring Boston Scientific in patent litigation between the company and Nevro. But the negative impact of the ruling on Nevro may be limited, analysts say.

Intellectual Property Medical Device

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

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

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

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