PERTH, Australia – See-Mode Technologies has received 510(k) clearance from the U.S. FDA to market its Augmented Vascular Analysis (AVA) program that uses artificial intelligence (AI) to analyze vascular ultrasound scans to better predict stroke. Caused by plaque that ruptures in blood vessels and blocks blood flow to the brain, stroke affects roughly 15 million people per year and is the second-leading cause of death globally.

Royal Philips NV is launching its Quickclear mechanical thrombectomy system in the U.S. four months after obtaining FDA clearance. “Quickclear's intuitive design simplifies the entire thrombectomy procedure work flow. Our new medical device can help bring cost-effective solutions in both the hospital and outpatient care settings,” Chris Landon, senior vice president & business leader, image guided therapy devices at Philips, told BioWorld.

Inari Medical Inc.'s Flowtriever device appears to offer a safer and more effective option for pulmonary embolisms than current treatment with thrombolytics or open embolectomy, according to prospective study presented at the TCT Connect 2020 conference.

Medtronic plc reported promising results from a feasibility study of its In.Pact 0.014 drug-coated balloon (DCB) in critical limb ischemia (ICL) patients with chronic total occlusion (CTO) in the infrapopliteal arteries.

Endologix LLC has begun a controlled launch of its Alto abdominal stent graft in Europe, following the receipt of CE mark approval in August. The next-generation Ovation system for polymer endovascular aneurysm repair (EVAR) is designed to provide the broadest indications in infrarenal EVAR grafts, including a 7 mm aortic neck length indication.

Fractional flow reserve (FFR) processing of computed tomography (CT) images has gained a substantial body of momentum over the past few years, but a recent study posed the question of whether it can save health care systems from excess spending for stable angina.

Shockwave Medical Inc., which is focused on intravascular lithotripsy (IVL) to treat severely calcified cardiovascular disease, saw its stock value rise Friday (NASDAQ:SWAV), eventually closing at $78.22, up $3.47, or 4.64%, following the presentation of positive results from the Disrupt CAD III trial.

The history of TAVR devices is evolutionary as much as it is revolutionary, or that is at least the take-away from an Oct. 15 virtual session comparing the Acurate Neo device by Boston Scientific Corp., of Marlborough, Mass., with the Corevalve Evolut R by Dublin-based Medtronic plc.

Medtronic plc management put an emphasis on being nimble and commercializing novel technology at its investor day this week, and analysts appeared to approve of the message. As Wells Fargo’s Larry Biegelsen noted, Dublin-based Medtronic is moving away from a centralized company that is focused on economic value and margin expansion to one that is more decentralized, emphasizing innovation and topline growth.