The US House Energy and Commerce Committee’s Health Subcommittee held a hearing on 12 June on proposed legislation to end “surprise medical billing,” spurred in part by out-of-network laboratory and advanced imaging bills, while Senate HELP Committee leaders continued to promote their own draft Lower Health Care Cost Act, addressing similar issues.

Medtech companies that have been loyal to LRQA could find themselves at a serious competitive disadvantage as the organization pulls out as a notified body for medical devices and IVDs, putting the whole medtech regulatory system under increased stress.

From not enough notified bodies and auditors, to a slew of new or updated international standards and regulations coming into force, the medtech industry is facing a number of NB challenges – and now they can add auditor burnout as a concern. "Because some of these notified bodies have such huge demand, they're burning people out really fast," industry expert Kim Trautman says, noting that device-makers can expect to see "boutique" notified bodies popping up over the coming decade. Also: Johnson & Johnson's regulatory director explains how the dearth of notified bodies and auditors is affecting the global medical products giant.

The complex system of credentialing staff from medtech and other life sciences organizations who wish to access hospitals in the UK has been simplified, with a new, easier-to-use alternative coming into place on 30 July. The ABHI’s Andrew Davies explains the changes.

Two EU member states have waded into the argument about the likelihood of the system needed for the implementation of the new MDR being ready on time and believe “options for solutions” need to be considered.

In the only device-related warning letter released by the US FDA this week, a maker of duel lumen catheters was cited for quality systems, Medical Device Reporting and recall violations.

The US FDA released six device-related close-out letters in May.

The US agency is still taking steps to shutter its Alternative Summary Reporting Program, despite an earlier soft commitment to end it by the end of last month.

Internal surgical fixation company Medartis announces new CEO; chairman of surgical hemostatis firm Biom’up also takes on role as CEO after previous CEO steps down; cardiovascular robotic systems-maker Robocath strengthens medical board with three international experts; and more.

Glooko, a leader in diabetes management data, and T1D Exchange, a nonprofit research group, have formed a collaborative agreement to use Glooko's platform to link anonymized diabetes device data from tens of thousands of type 1 diabetes patients with patients' electronic health-care records. See what T1D's Rebecca Parkes said about it here.

A negligence complaint against a Texas hospital that implanted a patient with a recalled Medtronic spinal device can move forward, a state appeals court ruled.

Glooko entered a partnership to integrate Companion Medical's InPen insulin data into Glooko's diabetes management systems.

New professional consensus guidelines recommend Vertos Medical’s minimally invasive lumbar decompression (MILD) system as an alternative to epidural steroid injections for patients with lumbar stenosis. The company is planning to raise more capital to expand its commercial operation so it can reach more patients that could benefit from MILD.

Shockwave Medical CMO brings experience from Boston Scientific Corp.; coronary artery detection firm HeartFlow chooses a CEO; blood glucose monitoring company LifeScan now has a former J&J Vision exec as head of marketing; and more.

The company recently launched six new implantable high-voltage cardiac rhythm management devices with the thin elliptical BIOshape to minimize the risk of skin erosion around the device pocket. Rivacor and Acticor also feature Biotronik's DX leadless atrial diagnostic technology, and MRI AutoDetect which automatically switches the device to a MR-safe mode when it enters a magnetic resonance imaging environment.

Senseonics will soon begin marketing its Eversense continuous glucose monitoring (CGM) system in the US as an alternative to fingerstick testing to help patients make diabetes treatment decisions throughout the day. See what CEO Tim Goodnow said about Eversense here.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week’s approvals include the FDA’s approval of new non-adjunctive labeling for Senseonics’ Eversense continuous glucose monitor and a de novo for Innovative Health Solutions’ IB-Stim percutaneous electrical nerve field stimulator to treat pain associated with irritable bowel syndrome.

Innovative Health Solutions IB-Stim percutaneous electrical nerve field stimulator is indicated to aid the reduction of functional abdominal pain in patients ages 11 to 18 with irritable bowel syndrome when combined with other therapies.

At this year's annual American Diabetes Association (ADA) conference, Abbott presented real-world data from its FreeStyle Libre CGM suggesting it reduces HbA1c in type 2 diabetics. Look for more ADA coverage this week.

The National Evaluation System for health Technology Coordinating Center announced 12 new test cases that use real-world evidence to examine medical device industry priorities. The list includes an Apple Watch study, as well as an FDA proposal on the use of pelvic mesh to treat urinary incontinence.