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Miles To Go? Case For Quality Founding Father Silverman Says Joint FDA/MDIC Initiative Isn't 'Where It Should Be'

Steve Silverman – one of the original architects of the popular Case for Quality when it was launched by US FDA in 2010 – is disappointed that the initiative hasn't come further over the past eight years. "I don’t think that the Case for Quality is where it should be," Silverman, who currently is AdvaMed's VP of technology and regulatory affairs, said at a Case for Quality open forum. His blunt words came despite the momentum building behind several ongoing Case for Quality projects, including a pilot program to assess device-makers' manufacturing maturity and capability.

Quality Control FDA Quality

Upsized Offerings Boost Medtech IPO Uptick

The public markets are receptive to medtech stock, with the first half of this year recording more – and bigger – medtech IPOs than a year ago.

Commercial Deals Financing

FDA Panel Backs Eased HIV Test Regs

A US FDA advisory committee said the agency should move forward with a proposal to down-classify some types of HIV tests, but panelists said the agency’s planned special controls might be too stringent to encourage innovation in the space.

Medical Device Diagnostics Advisory Committees

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

QUOTED. July 20, 2018. Kathie Bardwell.

Sterilization and decontamination technology firm Steris Corp. had two of its facilities appraised under a voluntary US FDA pilot program that aims to assess device-makers' manufacturing maturity and capability. See what Kathie Bardwell, VP and chief compliance officer for Steris, said about it here.

Quoted 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

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 Compliance

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

Trump Administration, Industry Want Stark Law Changes To Accommodate ACO Formation

The US administration and device industry are pushing Congress to create exceptions and waivers to Stark law requirements that prohibit physician self-referrals to radiological clinics or other medical facilities in which they have a financial interest. They say the law inhibits formation of accountable care organizations fostered by CMS, and hinders value-based health care.

Enforcement Legislation

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

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

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

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

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

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

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

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

Device Week, July 20, 2018 – H1 2018 Review: VC Funding, M&A, Approvals

In this edition of Device Week, Medtech Insight’s Tina Tan discusses trends in VC financing and M&A activity for medtech in 2018. Davide Filmore explains FDA’s latest approvals numbers, and Reed Miller gives an overview of the state of medical device approvals from outside the US.

Device Week Commercial

Investors Back Creo Medical With $63M In Funding

Investor confidence in Creo Medical is high. The surgical endoscopy specialist scored nearly £50m to support commercial launch for its electrosurgery device. The AIM-listed firm said the proposed placing, which was "significantly" oversubscribed, was raised through the issue of up to 38.8 million shares.

Commercial Financing

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

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

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

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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