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QUOTED.

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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

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

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 Independent.
Quoted Medical Device

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

QUOTED. July 11, 2018. Kristen Tabar.

Kristen Tabar, Toyota Motor North America's corporate quality VP, explains what's keeping the medical device industry from adopting "The Toyota Way," a 14-principle philosophy that aims to find the root causes of problems and add value by ensuring that company employees are fully developed, among other goals.

Quoted Quality

QUOTED. July 10, 2018. Joseph Drozda.

Missouri (US)-based hospital system Mercy is working with Johnson & Johnson and Medtronic on real-world data projects. Mercy's Joseph Drozda explains why the hospital is a go-to partner for device firms here.

Quoted Safety

QUOTED. July 9, 2018. Nele Zgavc.

British Standards Institution's Nele Zgavc is concerned about the device sector's ability to deliver harmonized standards in time for compliance deadlines with the EU's new Medical Device and IVD Regulations. See what she said about it here.

Quoted Standards

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

QUOTED. July 5, 2018. Nishan Sunthares.

The UK is undergoing big changes in its health-care system and medical device procurement in particular. Association of British HealthTech Industries' Nishan Sunthares highlights one of the device industry's hoped-for outcomes here.

Quoted United Kingdom

QUOTED. July 4, 2018. Greg Crist.

Device industry trade groups are doing their homework to support a new publicity campaign to target near-term votes in Congress to repeal the medical device excise tax. AdvaMed staffer Greg Crist describes the reasoning behind planned Washington, DC, bus-stop ad placements here.

Quoted Legislation

QUOTED. July 3, 2018. Luann Pendy.

Medtronic quality VP Luann Pendy  through the joint US FDA/MDIC Case for Quality  is on a mission to #makeCAPAcool. See what Pendy said she wants to do to CAPA (corrective and preventive action) here.

Quoted Quality

QUOTED. July 2, 2018. Juhi McClelland.

Tech giant IBM is teaming up with Aramark to fight hackers and tackle cybersecurity threats in hospitals. See what IBM's Juhi McClelland said about it here.

Quoted Business Strategies

QUOTED. June 29, 2018. Steve Silverman.

AdvaMed is finishing up work on a "Quality Culture Playbook" that it says will help push quality as an organization-wide concern within device firms. See what the industry advocacy group's VP of technology and regulatory affairs, Steve Silverman, said about quality culture here.

Quoted Quality

QUOTED. June 28, 2018. Gert Bos.

Complications from the new EU Medical Device and IVD Regulations continue to grow. See what consultant and notified body veteran Gert Bos has to say about the impact on planning for clinical trials.

Quoted Europe

QUOTED. June 27, 2018. Joe Friedrich.

For Boston Scientific, there were various reasons it had two of its facilities appraised by CMMI Institute under a US FDA maturity model pilot program. The company's quality assurance director, Joe Friedrich, talks about one of those reasons here.

Quoted FDA
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