XCath Robotics has FDA Breakthrough Device Designation for its in-development Iris surgical robotic system for mechanical thrombectomy to treat acute ischemic stroke. Houston-based XCath says the designation provides increased opportunities to interact with FDA experts and receive support during the regulatory development and review process for … [Read more...] about XCath Robotics receives FDA breakthrough nod for Iris system
Surgical Robotics
Stereotaxis reports first US procedures with MAGiC ablation catheter
Stereotaxis (NYSE:STXS) today announced the first patients successfully treated in the U.S. with its MAGiC system. MAGiC (magnetic interventional ablation catheter) delivers radiofrequency cardiac ablation to treat heart arrhythmia. The technology received FDA clearance at the start of this year, joining the FDA-cleared MAGiC Sweep robotically … [Read more...] about Stereotaxis reports first US procedures with MAGiC ablation catheter
Stereotaxis expects growth in 2026 with manufacturing ramp for new products
Stereotaxis (NYSE:STXS) today reported its fourth-quarter and full-year financial results ahead of expected growth in 2026. The company reported fourth-quarter revenue totaling $8.6 million, marking a 36% increase year-over-year. However, that fell shy of Wall Street expectations for $9.24 million. St. Louis-based Stereotaxis reported total 2025 … [Read more...] about Stereotaxis expects growth in 2026 with manufacturing ramp for new products
ProVerum, Zenflow win FDA nods for BPH treatment devices
ProVerum and Zenflow this week announced FDA approvals for their technologies that treat benign prostatic hyperplasia (BPH). Dublin, Ireland-based ProVerum won approval for its ProVee system. Zenflow got the green light for its Spring implant and delivery system. Both companies aim to offer a potential treatment for BPH, a common urological … [Read more...] about ProVerum, Zenflow win FDA nods for BPH treatment devices
Stereotaxis Magic ablation catheter is now CE mark approved
Stereotaxis (NYSE:STXS) said today that it has secured CE mark approval for its Magic robotically-navigated magnetic ablation catheter. The St. Louis–based robotic surgery company submitted Magic for both CE mark and FDA approval nearly a year ago; it still awaits an FDA nod in the U.S. Magic performs cardiac ablation procedures to treat … [Read more...] about Stereotaxis Magic ablation catheter is now CE mark approved
Microbot Medical announces $7M offering to support surgical robot commercialization
Microbot Medical (Nasdaq:MBOT) announced today that it entered into definitive agreements for the purchase and sale of common stock for proceeds of $7 million. The offering includes just over 4 million shares of common stock priced at $1.75 per share. In an additional concurrent private placement, the company plans to issue unregistered … [Read more...] about Microbot Medical announces $7M offering to support surgical robot commercialization
Microbot Medical submits Liberty surgical robot to FDA
Microbot Medical (Nasdaq:MBOT) announced today that it submitted an FDA 510(k) premarket notification for its Liberty surgical robot. Microbot designed its Liberty single-use endovascular surgical robot for potential use in neurovascular, cardiovascular and peripheral vascular procedures. The system includes a compact design and remote operating … [Read more...] about Microbot Medical submits Liberty surgical robot to FDA
Medtronic acquires articulating instrument maker Fortimedix Surgical
Fortimedix Surgical announced today that it has been acquired by medtech giant Medtronic (NYSE:MDT). "We are pleased to share that Fortimedix Surgical was acquired by Medtronic," the company wrote on LinkedIn. "A unique opportunity to leverage our articulating instrument technology for application across patient therapies. We look forward to … [Read more...] about Medtronic acquires articulating instrument maker Fortimedix Surgical
Stereotaxis to acquire Access Point Technologies and its EP catheters
Stereotaxis (NYSE: STXS) is purchasing a Minneapolis-based electrophysiology (EP) catheter maker to further enhance its minimally invasive endovascular surgical robotics technology. St. Louis–based Stereotaxis did not disclose how much it is paying for Access Point Technologies in its after-hours news release. The transaction, paid with … [Read more...] about Stereotaxis to acquire Access Point Technologies and its EP catheters
