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.
Momentis Surgical Ltd. received 510 (k) clearance from the U.S. FDA for the second-generation of the Anovo robotic surgical platform. The upgraded system allows surgeons to experience enhanced ergonomics with integrated haptic feedback, creating more intuitive control of the robotic arms during surgical procedures.
Zap Surgical Systems Inc. reported closing a $78 million series E funding round led by Qingdao Baheal Medical Inc., with participation from other strategic investors. The new funds will be used to commercialize the company’s Zap-X gyroscopic radiosurgery platform for the non-invasive treatment of brain tumors.
A Delaware chancery court decreed that Johnson & Johnson Inc. owes investors in Auris Health Inc. more than $1 billion over allegations that J&J had undercut Auris products after the 2019 acquisition of Auris. The outcome highlights the hazards of acquisitions of companies that are competitive in a particular product space, but a shift in FDA policy regarding robotic surgical systems may have also played a role in this outcome.
CMR Surgical Ltd. recently submitted its application to the U.S. FDA for approval for its Versius surgical system as it seeks to get more surgeons using the small, portable, robotic tool in laparoscopic procedures.
Siemens Healthineers AG made a binding offer to Novartis AG, of Basel, Switzerland, to acquire its Advanced Accelerator Applications Molecular Imaging business which includes the European manufacturing and distribution network of diagnostic radiopharmaceuticals for positron emission tomography scans.
Vitestro Holding BV received CE marking for its automated blood drawing device which uses artificial intelligence, ultrasound-guided imaging and robotics to ensure accurate and secure blood collection. The device is the first of its kind to achieve CE mark and the company believes it will be transformational for health care.
In an earnings call, Asensus Surgical Inc. told shareholders it will have to file for bankruptcy if they do not approve the previously reported merger with Karl Storz Se & Co. KG.
Moon Surgical SAS recently received U.S. FDA clearance for the commercial version of its Maestro surgical robotic system for laparoscopic procedures. The greenlight is “pretty massive” for the company as it will allow the robotic platform to be rolled out in the U.S., to help enhance the surgeon’s performance while carrying out procedures, Anne Osdoit, CEO of Moon Surgical, told BioWorld.
News out of the Heart Rhythm Society 2024 meeting May 16-19 highlighted the rapid disruption pulsed field ablation (PFA) devices have wrought in cardiac arrhythmia treatment, so it is little surprise to see that PFAs are among the top five technologies with transformative potential identified by Clarivate plc in its Medical Technologies to Watch in 2024 report. The impact of the other four – continuous glucose monitors (CGM) for diabetes, neurostimulation devices, surgical robotics and renal denervation – has been just as revolutionary, if longer in being realized.