Relievant’s Intracept intraosseous nerve ablation system is the only FDA-cleared neuromodulation device indicated to treat vertebrogenic pain. Boston Scientific will pay $850m for Relievant, plus undisclosed milestone payments over the next three years.

With the end of fiscal 2023 just over a week away, the US Food and Drug Administration has been publishing promised guidance documents, action plans and white papers.  Medtech Insight’s round-up of four device-specific documents is below.

An all-female panel of medtech DEI leaders at the LSX Congress USA conference discussed the importance of diversity and inclusion in research, clinical trials, product development and services to advance health equity as well as fundamental business goals.

A small scale study has indicated that GLP-1 agonists could restore normal HbA1c levels in type I diabetics. This therapy could be a huge step forward for the treatment of this chronic disease if this benefit is shown in larger studies.

The Paris-based start-up has picked up a CE mark for the latest generation of its Maestro system, a tool designed to make laparoscopic surgery easier and safer.

Medicare coverage of innovative and life-saving devices, drugs and diagnostics were the focus of a 19 September Congressional hearing during which representatives pressed for swifter and more predictable paths to reimbursement.

Medtech developers have just over a month to apply for the pilot phase of a program offering regulatory and practical support to accelerate innovative product access to the UK NHS.

An all-female panel of medtech DEI leaders at the LSX Congress USA conference discussed the importance of diversity and inclusion in research, clinical trials, product development and services to advance health equity as well as fundamental business goals.

The Paris-based start-up has picked up a CE mark for the latest generation of its Maestro system, a tool designed to make laparoscopic surgery easier and safer.

This week, Medtronic presented data from two new real-world trials confirming that ICDs save lives; a restraining order was issued against EOFlow in Insulet’s intellectual property case; and Polarean’s MRI gas XENOVIEW received a new Medicare reimbursement code.  

The majority of FDA’s circulatory systems devices panel agreed that ReCor’s Paradise ultrasound renal denervation system offers a safe and effective therapy for patients with hypertension. The panel’s endorsement means ReCor will likely be the first company to reach the US market with an RDN system.