Stereotaxis Inc. secured U.S. FDA approval for its Magic magnetic interventional ablation catheter, marking a key step in the company’s effort to evolve from a niche robotics supplier into a more vertically integrated electrophysiology technology provider. The approval positions Magic as Stereotaxis’ first proprietary robotic ablation catheter in the U.S. and follows a series of regulatory and commercial milestones in recent months that reset the company’s growth narrative.
Continuing a cascade of positive news for Stereotaxis Inc., the company reported the first order for its petite Genesisx robot in Europe. The system received CE mark in August, but management held off its launch until its Magic radiofrequency ablation catheter also received CE mark, which happened on Jan. 27. The two devices are used together to treat cardiac arrhythmias.
Stereotaxis Inc. and Chinese partner Shanghai Microport EP Medtech Co. Ltd. gained the National Medical Products Administration’s approval of its Magbot magnetic navigation ablation catheter Dec. 9 for use with Stereotaxis’ robotic ablation system to treat drug-resistant cardiac arrhythmias in China.
Stereotaxis Inc. Genesisx received the greenlight from the EU authorities for its next generation robotic system, which it says builds on the benefits and performance of the previous Genesis while greatly reducing its barriers to adoption.
Stereotaxis Inc. recently received CE mark recertification for all its devices currently available in Europe under the new Medical Device Regulation (MDR) regulatory framework. The MDR has replaced the European Medical Device Directive and includes more stringent standards but meeting the new requirements comes with frustrations and costs for many companies.
Stereotaxis Inc. said it is buying electrophysiology catheter maker Access Point Technologies EP Inc. to enhance its minimally invasive endovascular surgical robotics technology offerings.
Stereotaxis Corp. reported positive results showing its robotic magnetic navigation (RMN) system significantly reduces the incidence of silent cerebral embolism (SCE) in patients undergoing atrial fibrillation (AF) ablation vs. hand-held catheters. The prospective, multicenter study is believed to be the first to compare AF ablation using RMN with manual control and to highlight the benefit in lowering SCE risk.
Robotic technologies company Stereotaxis Inc. is scaling up its footprint in the Chinese med-tech market, with a deal to commercialize its robotic technology for heart rhythm therapy in China with Shanghai Microport EP Medtech Co. Ltd. The St. Louis-based Stereotaxis aims to introduce a second-generation robot called Genesis to the Chinese market that uses a magnetic navigation technology to treat heart rhythm disorders. Its partner, Shanghai Microport EP Medtech, is a division of one of China's largest med-tech manufacturers, Shanghai-based Microport Scientific Corp.
Despite the ongoing pandemic, Acutus Medical Inc. (NASDAQ:AFIB) decided to go down the IPO route. It officially started trading today after reporting its offering of more than 8.8 million shares of its common stock at $18 per share, with expected gross proceeds of $158.8 million. Last month, the Carlsbad, Calif.-based company estimated that the IPO price per share would be between $16 and $18.
