Topic: FDA

News

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.

News

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.

News

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.

News

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.

News

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.

News

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.

News

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.

News

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.

News

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.

News

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.

News

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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