In this guest editorial, Consensys Imaging Service President Jim Spearman argues that third-party servicers of devices need to be held to the same quality management system standards as original equipment manufacturers – including mandatory reporting to FDA of adverse events and alterations they observe rendering the equipment they service unsafe or ineffective.

Orthopedic surgeons never favored mandatory bundled-payment programs such as the Comprehensive Care for Joint Replacement model. In fact, in comments to CMS, surgeons requested that the US Center for Medicare and Medicaid Innovation make the programs voluntary and scale them back.

The EU's new Medical Device Regulation doesn't appear to regulate 3D-printed medical products in the same way that all standard devices are controlled, Hogan Lovells attorney and life-sciences expert Joerg Schickert explains. See what he said about it here.

German medtech manufacturers hope that the fledgling coalition government's promise to give new impetus to the long-running national medtech strategy initiative will help achieve the very innovations that much-vaunted reimbursement fast-tracking mechanisms have failed to yield.

Given that 3D printing is used for making device implants, many would expect tight regulation. But the EU Medical Device Regulation does not specifically regulate it, and there may be easier routes to compliance than companies think, according to attorney Joerg Schickert.

US FDA did not release any device-related warning letters the week of April 24.

Sunlite Plastics Inc. is the first and only manufacturer to be accredited to the industry-managed MedAccred for plastics extrusion.

Health Canada is making it easier for device manufacturers to transition to the Medical Device Single Audit Program by the 2019 deadline.

A new document has just been published to help manufacturers and notified bodies meet the quality system requirements of the new EU Medical Device and IVD Regulations. BSI's Paul Sim explains its value.

Aleva Neurotherapeutics has made two senior management appointments  as it prepares to take its first deep brain stimulation product to CE mark approval and to market.

Terumo has merged its two subsidiaries, Vascutek and Bolton Medical, to create a $200m-revenue player in the peripheral vascular implant scene.

Device manufacturer Allergan has agreed to pay $4m in two separate settlements involving the Lap-Band bariatric surgery device.

Oxygen device manufacturer Inogen is recovering from a data breach. The company disclosed in a financial filing that hackers accessed private data from approximately 30,000 customers.

In this weekly feature, Medtech Insight presents a roundup of the previous week's M&A deals and venture financing rounds recorded in our M&A and VC Deal Trackers. This edition presents the transactions announced April 16-22, 2018.

Check out what Wells Fargo analyst Larry Biegelsen had to say about why a global patent battle between Edwards Lifesciences and Boston Scientific on transcatheter aortic valve replacements will likely end in settlement.

Clinical-trial disclosure requirements can be a major complication for device firms. See what TrialScope VP Francine Lane has to say about it.

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 the trial announcements between April 17-23, 2018. This week's edition include trial announcements from Jarvik, Admedus, Emboline and Endonovo Therapeutics. 

ILUMIEN IV is the largest-ever prospective randomized trial to compare an intravascular imaging modality, plus angiography, to angiography alone in coronary interventions, according to Abbott. The trial will enroll up to 3,650 patients with high-risk complex disease at 125 centers in North America, Europe and Asia to determine if OCT-guided stenting yields larger vessel diameters and improves clinical outcomes for patients compared to stent procedures guided by standard angiography.

A US FDA advisory panel unanimously voted down the AngelMed cardiac monitor two years ago. But venture-backed Angel Medical Systems was able to engage with the agency after the panel, and the firm ultimately achieved approval of the device designed to help detect heart attacks earlier. It’s a lesson in firms leveraging all the data they have at their disposal.

The first quarter of 2018 brought 90 approvals from outside the US, including 56 in Europe, according to Medtech Insight's Approvals Tracker. The biggest category of approvals was cardiovascular, with several new drug-eluting stents and heart-valves coming through during the first three months of the year. Check out our infographic spotlighting the Q1 trends.