Procept BioRobotics (Nasdaq:PRCT) announced today that it received FDA investigational device exemption (IDE) for its Aquablation therapy. The IDE allows Procept to initiate a single-arm feasibility study for the Aquablation prostate cancer therapy in the U.S. Data generated from the study could support future research and regulatory applications in the U.S. The company plans to […]
Surgical
FDA clears mixed reality cranial surgical navigation system from Zeta Surgical
Zeta Surgical announced today that the FDA cleared its mixed reality surgical navigation system for neurosurgery. The Zeta cranial navigation system provides surgeons with GPS-like guidance and millimetric accuracy in real time. Boston-based Zeta Surgical designed it with a computer vision engine to ensure maintained accuracy. It automatically registers multiple times per second, accounting for […]
Quantum Surgical wins CE mark to treat lung tumors with its surgical robot
Quantum Surgical recently announced that it received expanded CE mark approval for the use of its Epione surgical robotic platform. The Montpellier, France–based company won expanded indications for Epione in the treatment of lung tumors. Epione, the company’s flagship product, offers curative treatment for cancers. Quantum Surgical designed it to plan, target, deliver and confirm […]
Asensus, Nvidia to collab on AI for surgical robotics
Asensus Surgical (NYSE:ASXC) announced today that it entered into a collaboration with Nvidia to accelerate the development of its ISU. The partnership aims to enhance the ISU (Intelligent Surgical Unit), part of Asensus’ performance-guided surgery offerings. Asensus designed its flagship Senhance surgical robot platform around the ISU. The real-time intraoperative surgical image analytics platform leverages […]
Ronovo Surgical raises $26M for surgical robot platform
Ronovo Surgical announced its second successful fundraising round in the past eight months, bringing in $26 million to support its surgical robot. Shanghai, China-based Ronovo closed a funding round in February, also unveiling its Carina surgical robotic platform. The $26 million in the latest round brings the company’s total fundraising to more than $76 million […]
Noah Medical presents positive first-in-human surgical robot data
Noah Medical announced new data demonstrating the navigational success and safety of its Galaxy surgical robotic system. Data came from the bronchoscopic visualization and access platform’s first-in-human trial. Noah presented it at the American Association of Bronchology and Interventional Pulmonology conference (AABIP 2023) in Chicago. According to a news release, the presentation marked the public […]
Orthofix launches new spine surgery navigation system
Orthofix Medical today announced the full U.S. commercial launch for its 7D Flash navigation system percutaneous module 2.0. The company also confirmed the completion of the first cases in the U.S. with the module. It provides new planning features and increased functionality for the 7D Flash navigation system for minimally invasive spine surgery. The 7D […]
Integra Lifesciences hit with FDA warning letter over Boston facility
The FDA says Integra Lifesciences has inadequately responded to violations that it found at the company’s TEI Biosciences plant in Boston. Integra Lifesciences’ Boston facility makes extracellular bovine matrix products for tissue repair and regeneration, wound care and more. In May, the company voluntarily recalled all tissue-related products made in Boston and distributed between March 1, […]
Cydar Medical, Medtronic treat first patient in AI mapping collaboration
Cydar Medical today announced the successful treatment of the first patient in a strategic collaboration with Medtronic . The collaboration spans 40 sites across the U.S., UK and Europe, integrating the Cydar Maps software with Medtronic services and case support. The collaboration aims to improve patient care and efficiency with AI-based solutions placed into the […]
Nurami Medical wins FDA clearance for dural repair graft for neurosurgery
Nurami Medical announced that it received FDA 510(k) clearance for its electrospun, nanofiber-based ArtiFascia dura substitute. The Haifa, Israel-based company plans to begin U.S. sales of the resorbable dural repair graft soon. ArtiFascia assists in the process of replacing the dura mater — which protects the brain and cerebrospinal fluid (CSF) — in neurosurgery. It […]
Levita Magnetics wins FDA clearance for magnetic-assisted surgical robot
Levita Magnetics announced today that the FDA approved its MARS magnetic-assisted robotic surgery platform. Mountain View, California-based Levita designed its MARS minimally invasive surgical platform for the high-volume abdominal surgery market. It combines magnets and machines to reduce the number of incisions, enabling complete control during laparoscopic procedures. The system comes in a compact footprint […]