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.

The Medicare agency is working with US FDA on a parallel review process for non-addictive medical device pain control products and non-opioid drug alternatives to treat chronic pain, Kimberly Brandt, a CMS deputy administrator, told the Senate Finance Committee April 19.

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.

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.

The EU Council is scheduled to debate the European Commission's EU-wide health technology assessment proposal today, but opposition to the concept within medtech circles has started to mount, notably in Germany.

Medical Device Reporting violations noted at maker of the SynCardia Temporary Total Artificial Heart System in the only device-related warning letter released by US FDA this week.

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?

When a device-maker initiates a medical device recall, it's wise for the firm to work hand-in-hand with regulators to ensure that the product is removed from the market before it causes troubles for users. Chris Harvey of Stericycle ExpertSOLUTIONS offers tips in this Medtech Insight guest column for making sure that happens. He highlights five cardinal rules to ensure a smooth recall process.

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.

The global orthopaedic implant market will have a new bulked-up Anglo-Sino player after China's AK Medical and the UK's JRI Orthopaedics have inked a merger deal.

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.

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.

US FDA has approved Medtronic's plan for the SPYRAL HTN Pivotal Trial, part of the SPYRAL HTN Global Clinical Program. SPYRAL HTN is a multi-phased clinical study strategy to establish the safety and efficacy of renal denervation with the Symplicity Spyral system to reduce blood pressure in patients with uncontrolled hypertension. The Spyral device and procedure, as well as the design of the SPYRAL HTN clinical trial, reflect lessons learned from SYMPLICITY HTN-3, the first sham-controlled trial of renal denervation, which famously failed to show a benefit of the procedure.