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.

The US administration and the medical 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 the Centers for Medicare and Medicaid Services, and hinders value-based health care.

Principal Deputy Commissioner Sherman remains top policy guru and will oversee consolidation of functions currently scattered throughout FDA into the Office of Operations.

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.

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.

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.

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.

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.

Medical device manufacturer AngioDynamics has agreed to pay $12.5m to resolve allegations the company encouraged health-care providers to submit false claims for two of the company’s products.

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.

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.

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.

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.

The company announced the launch of a US randomized trial of its ECG Belt Research System, a tool to optimize cardiac resynchronization.

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.

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.