FDA has granted Endologix a breakthrough device designation for the ChEVAS System, an endovascular abdominal aortic aneurysm (AAA) sealing technology that combines the Nellix 3.5 endograft with parallel visceral stents to enable treatment of patients with juxtarenal, pararenal and suprarenal AAA. Endologix has been plagued with a series of challenges since 2016, when FDA said the company's Nellix EndoVascular Aneurysm Sealing System might need to be reviewed by an advisory committee. Additional roadblacks ultimately led to Chapter 11 bankruptcy last year, followed by an agreement to go private.
And in case you missed our last Medtech in a Minute report...
Hillrom wanted to opt-out of acquiring Bardy Diagnostics because it claimed Medicare rate cuts for long-term cardiac monitoring constituted a material adverse event to the merger agreement. The Delaware Chancery Court denied Hillrom’s claim, however. BardyDx developed the Carnation Ambulatory Monitor Patch, a device designed to promote patient compliance, streamline clinical workflow, and yield clinically actionable data in a report. Hillrom now says it will evaluate its strategic options, and that it plans to appeal the court's decision.
Just as the electrophysiology (EP) market is really heating up, Royal Philips has added a new 3D intracardiac echocardiography (ICE) catheter to the mix. Philips says its new real-time 3D intracardiac echocardiography (ICE) catheter has the potential to improve standard of care for structural heart disease and EP procedures.
Viz.ai’s flagship solution, Viz LVO, uses AI to automatically detect suspected large vessel occlusion (LVO) strokes on computed tomography angiography imaging and directly alert on-call stroke specialists about potentially treatable patients in a standalone or multi-hospital network. In 2018, MD+DI named Viz.ai as one of six AI companies set to rock the medtech world.
Medtronic broke ground on a 400,000 square foot Lafayette, CO innovation center and campus. The new campus is intended to unite employees from Medtronic's Boulder, CO and Louisville, CO facilities onto one campus. The company's manufacturing operations currently at the Boulder and Louisville campuses will remain there. Anticipated to be complete with staff moving in during the second half of 2022, the plan includes two five-story connected buildings, which will host 1,100 employees.