Dublin-based Medtronic plc has filed a PMA supplement with the U.S. FDA for its next-generation, implantable sacral neuromodulation (SNM) device, Interstim Micro, and for its Interstim Surescan MRI leads. Interstim Micro is intended to help patients with overactive bladder (OAB), urinary urge incontinence, unobstructed urinary retention and fecal incontinence (FI).

SAN FRANCISCO – As the transcatheter aortic valve replacement (TAVR) field matures, it is becoming increasingly difficult to develop a new implant that can distinguish itself vs. competitors. The incremental benefits are narrowing rapidly, making it tough to distinguish new iterations from one another using standard, randomized trials.

BOSTON – How are med-tech companies reacting to the findings of the EY Pulse of the Industry report 2019? Members of a panel examined this question this week during the Medtech Conference in Boston, while also offering their insight on where the industry is headed.

SAN FRANCISCO – The accelerating confluence of information technology and medical devices is transforming the latter into a true embodiment of med tech. That was the conclusion of early keynote sessions at the Transcatheter Cardiovascular Therapeutics (TCT) that began here yesterday.

Dublin-based med-tech conglomerate Medtronic plc took the time to show off its investigational minimally invasive robotic surgery system that's expected to squarely take on long-time segment leader Intuitive Surgical Corp. Ahead of the robotic surgery-focused investor event on the afternoon of Sept. 24, Medtronic unveiled details of the system in an SEC filing.

BOSTON – What are companies doing to be successful in the current environment of med-tech M&A valuation? That question was posed to panelists from three top device makers during the Medtech Conference Tuesday morning. Specifically, the panel, which featured representatives from New Brunswick, N.J.-based Johnson & Johnson, Medtronic plc and Boston Scientific Corp., looked at overall valuations across the sector, as well as what it takes to produce a successful M&A strategy.

Irvine, Calif.-based Axonics Modulation Technologies Inc., which has developed an implantable rechargeable sacral neuromodulation (r-SNM) device for the treatment of urinary and bowel dysfunction, has won the FDA's nod for its system to help patients with fecal incontinence.