VIVATRONIX and SpineX announce xStep device approval from CDSCO
October 10, 2025
The xStep device offers painless, non-invasive electrical stimulation to the spinal cord to treat paralysis.
The xStep device offers painless, non-invasive electrical stimulation to the spinal cord to treat paralysis.
An Abbott (NYSE: ABT)+
official posted on social media to announce FDA breakthrough device designation for a new ablation catheter.
ST. LOUIS, Oct. 9, 2025 /PRNewswire/ — Amplifi Vascular, developer of the first-of-its-kind Vein Dilation System designed to increase eligibility, improve creation and early maturation of arteriovenous fistulas (AVFs) for hemodialysis, today announced three major milestones: positive first-in-human (FIH) study results, the close of a $6.9 million Series A financing, and U.S. Food and Drug Administration (FDA) approval of its Investigational Device Exemption (IDE).
BOERNE, Texas, Oct. 8, 2025 /PRNewswire/ — Building once again on their first mover position as a leader in endovascular hemorrhage control and resuscitation, Prytime Medical Devices, Inc. (Prytime) this week announced a new FDA 510(k) clearance for their flagship pREBOA-PRO™ Catheter.
ntuitive Surgical (Nasdaq: ISRG)+
announced today that it received FDA clearance for new software advancements for its Ion endoluminal robot.
SALT LAKE CITY, Oct. 7, 2025 /PRNewswire/ — Xenocor, Inc., a leader in single-use surgical visualization, proudly announces the issuance of U.S. Patent No. 12,429,685 B2 for its innovative medical borescope and tip assembly technology. This milestone reinforces Xenocor’s commitment to advancing safe, efficient, and accessible minimally invasive procedures through disposable and digitally optimized laparoscopic tools.
Vektor Medical today announced it received CE mark approval for its vMap artificial intelligence-powered arrhythmia mapping system.
GROVE CITY, Ohio, Oct. 6, 2025 /PRNewswire/ — Tosoh Bioscience, Inc., a market leader in clinical diagnostics is proud to announce that it has received US FDA 510(k) clearance for its next-generation system for HbA1c testing – the Tosoh Automated Glycohemoglobin Analyzer HLC®723-GR01 (hereafter “GR01”). The GR01 is intended for monitoring the long-term blood glucose control of individuals with diabetes, as an aid in the diagnosis of diabetes and to help identify those who may be at risk of developing the disease.
GlucoSet announced today on social media that it received FDA breakthrough device designation for its glucose monitoring technology.
IceCure Medical (Nasdaq:ICCM) announced today that the FDA granted marketing authorization for its ProSense cryoablation system for breast cancer.