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.

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

The EU is recreating its medical device database to arguably become the most modern repository of vital medtech information, including on safety-related incidents. Will non-EU authorities get a look?

The House Energy and Commerce Committee is asking stakeholders to help prevent cyberattacks on medical devices and systems, citing recent attacks. One key issue cited by the committee: simply asking companies to update legacy devices or switching out those devices for newer ones is unfeasible.

EU is taking steps toward better understanding of the human genome by setting up an eHealth Cooperation Linking Genome Databases. It will provide the medtech industry with vital new information.

Blockchain has been highlighted as a helpful vehicle for communication and traceability in the medtech sector. The technology looks set to proliferate in the EU with a new cooperation partnership.

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.

Medical device firms were issued 35 quality-related warning letters by US FDA last calendar year – the lowest number recorded since the agency's Quality System Regulation came into force in 1996. Officials in FDA's device center stressed in an interview with Medtech Insight that there's no specific reason why so few letters were mailed to companies in 2017, although they said the agency's ongoing compliance and enforcement outreach to device-makers might have played a role in last year's anemic count. Also: Might FDA apply "least burdensome" concepts to its warning letter and close-out processes?

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.

CR Bard has lost the first transvaginal mesh case to be tried in New Jersey, but there are another 150 to go in the state. A Bergen County jury awarded $33m in compensatory damages and $35m in punitive damages to a woman who says she's experienced chronic pain and other complications since receiving two of the company's transvaginal mesh products in 2009.

For device-makers that want to capitalize on opportunities arising from Asia's ever-burgeoning health-care systems, relationships are indeed critical to a successful APAC business strategy. Check out what Accuron Medtech CEO Abel Ang said about it here.

The European Patent Office sided with Boston Scientific on April 16 in agreeing to revoke an Edwards Lifesciences patent on a technology used in transcatheter aortic valve replacement (TAVR) devices.

Boston Scientific has expanded its gynecology/urology portfolio with the acquisition of nVision Medical, the maker of the first US FDA-cleared device designed to collect cell samples from the fallopian tubes for early ovarian cancer diagnosis. 

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 9-15, 2018.

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.

An infographic to spotlight US FDA device approval trends during the first quarter, January through March.