US Rep. Rosa DeLauro had a tense exchange with US FDA Commissioner Scott Gottlieb over the agency's handling of Bayer's Essure birth-control device. Check out what the Rhode Island democrat said here.

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

After Abbott recently settled a case against short-seller Muddy Waters, the company has put out a second cybersecurity patch for certain St. Jude radio-frequency enabled cardiac devices to stop potential hackers from harming patients.

Members of a US House Appropriations Subcommittee interrogated FDA Commissioner Scott Gottlieb on the agency's proposed 2019 budget and his newly released device safety plan. One fierce critic, Rep. Rosa DeLauro, D-RI, attacked Gottlieb's efforts to allow third-party certifiers to approve device quality manufacturing processes, and said his safety plan looked like a "high-risk" action plan.

South Africa is undergoing a transition to a new regulatory regime. Check out what South African Medical Technology Industry Association's Tanya Vogt had to say about it here.

In a new "action plan," FDA is stitching together a plethora of ongoing and proposed initiatives to help spur product safety and quality efforts through increased regulatory authority and more incentives for device-makers.

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?

C.R. 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. 

As the threat of cybersecurity vulnerabilities in medtech has grown, so has interest in tackling the problem from both industry and regulators. In an effort to assist in developing a manual to help companies manage threats, the public-private Medical Device Innovation Consortium is taking research bids.

Philips and Digital China Health, the largest provider of cloud-based healthcare services in China, have launched the Shinefly teleradiology application and services platform to help Chinese health-care providers manage their radiology workload and information output.

A new study sponsored by OncoDNA shows a combination of molecular tests could improve cancer treatment and help oncologists in routine clinical practice.

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.

Starts & Stops features noteworthy clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers the trial announcements between April 9 and April 16, 2018. This week's edition include trial announcements from Abbott, Johnson & Johnson, Biotronik and Medtronic.

Veteran cardiology device trial investigator Laura Mauri will join Medtronic as VP-Global Clinical Research & Analytics on Sept. 1, leading the development of new analytical and data science for the medtech giant.