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Topic: FDA


Stereotaxis Submits Robotically Navigated MAGiC Ablation Catheter for CE Mark
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.

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

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

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

CUREXO Surgical Robot CUVIS-Spine Gets FDA Approval
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.

Medical Device Simulation’s Next Frontier
Simulation-led workflows now dominate early-stage device design and have edged into bench testing and validation.

3D Printing Pumps Out Essential PPE
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.

America Makes Launches Next Phase in COVID-19 Response
Additive manufacturers can now upload 3D print designs to be reviewed and placed on the NIH 3D Print Exchange.

Stratasys Printers Validated by FDA for Medical Modeling
Materialise and Stratasys have expanded their partnership in the healthcare space

FDA Releases Medical Device 3D Printing Guidelines
3D printing guidelines are useful for manufacturers planning product submissions for FDA approval, and will improve the position of the U.S. in the worldwide additive manufacturing medical-device marketplace.

FDA Plans More Research on 3D Printing
The FDA has released a new video outlining its plans for further 3D printing research and regulation.


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