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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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