Topic: FDA

News

ABB Robotics, Roche Diagnostics collaborate to bring physical AI to laboratories

July 19, 2026 · ABB Robotics and Roche announced a collaboration to generate digitally connected labs enabled by intelligent robotics to provide significant efficiencies in laboratory workflows.

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MMI receives FDA clearance, completes first U.S. clinical use of robotic microsurgical dissection instruments

December 29, 2025 · Medical Microinstruments (MMI) treated its first U.S. patient with its NanoWrist Dissection instruments, representing an early clinical adoption milestone for its surgical systems.

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Stereotaxis’ GenesisX Robotic Magnetic Navigation system receives U.S. FDA clearance

November 13, 2025 · Stereotaxis announced its GenesisX Robotic Magnetic Navigation minimally invasive endovascular surgical system received U.S. FDA 510(k) clearance.

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Medical Microinstruments receives FDA approval for first robotic microsurgical study in Alzheimer’s patients

November 9, 2025 · Medical Microinstruments (MMI) received approval for an Investigational Device Exemption from the FDA on a study using a novel microsurgical intervention for Alzheimer’s disease.

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Dr. Vipul Patel performs Africa’s first robotic telesurgery from Florida

June 20, 2025 · Dr. Vipul Patel performed a radical prostatectomy on an Angolan man in an Angolan hospital remotely from Orlando, Florida in Africa’s first robotic telesurgery.

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Virtual Incision Completes FDA Investigational Device Exemption Clinical Study for MIRA

February 24, 2023 · Virtual Incision claimed that it was the first robot-assisted surgical developer to complete a study to support a De Novo request for MIRA to conduct bowel resection procedures.

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Stereotaxis Submits Robotically Navigated MAGiC Ablation Catheter for CE Mark

July 11, 2022 · Stereotaxis, which has developed the MAGiC system for minimally invasive diagnosis and treatment of cardiac arrhythmias, is working toward European and U.S. approvals for commercialization.

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Auris Health Surgical Robot System Receives FDA 510(k) Clearance for Urological Procedures

May 3, 2022 · Auris Health will soon start human clinical studies for its surgical robot system after receiving 510(k) clearance for bronchoscopy and urology from the FDA.

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Virtual Incision Gets OK From FDA for Clinical Studies on Bowel Resection Procedures

April 19, 2022 · Virtual Incision announced that the FDA has granted it an Investigational Device Exemption to complete research on how its robot-assisted surgery platform can aid bowel resection procedures.

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Titan Medical Aims to Bring Surgical Robot to Market for Gynecological Procedures by 2025

April 13, 2022 · Titan Medical is working toward FDA approval of its Enos minimally invasive surgical robot with the goal of bringing it to market within the next three years.

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CUREXO Surgical Robot CUVIS-Spine Gets FDA Approval

May 24, 2021 · CUREXO plans to market its CUVIS-spine system for minimally invasive surgery worldwide now that it has FDA approval in addition to South Korean and European CE certification.

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Medical Device Simulation’s Next Frontier

January 6, 2021 · Simulation-led workflows now dominate early-stage device design and have edged into bench testing and validation.

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3D Printing Pumps Out Essential PPE

June 4, 2020 · Private citizens and corporate enterprises are turning to 3D printing to buttress the limited stock piles of much-needed Personal Protective Equipment (PPE) during the COVID-19 pandemic.

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America Makes Launches Next Phase in COVID-19 Response

April 2, 2020 · Additive manufacturers can now upload 3D print designs to be reviewed and placed on the NIH 3D Print Exchange.

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Stratasys Printers Validated by FDA for Medical Modeling

December 20, 2018 · Materialise and Stratasys have expanded their partnership in the healthcare space

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