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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker.

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.