Hogan Lovells steers Memic to De Novo FDA authorization for a surgical robotic system
Washington D.C., 1 March 2021 – Global law firm Hogan Lovells advised Memic, an Israel-headquartered medical device company dedicated to transforming robot-assisted surgery, in its regulatory strategy and submissions to secure Food and Drug Administration (FDA) market authorization for its Hominis Surgical System, a robot-assisted surgical platform for use in transvaginal gynecologic procedures including benign hysterectomy.
The Memic Hominis system features miniature humanoid-shaped robotic arms that provide human level dexterity, multi-planar flexibility and 360 degrees of articulation, and offers a more cost-effective and less invasive option over currently available robotic-assisted surgical options for hysterectomies.
The authorization, which was granted Friday, is the first FDA authorization for a robotic-assisted system for transluminal surgical procedures. The system was reviewed by FDA through the De Novo pathway. A De Novo authorization establishes a new classification category for novel medical device products and is accompanied by special controls defining labeling and testing requirements for devices of this type.
The De Novo was supported by a clinical study evaluating the Hominis system in 30 hysterectomies where 100 percent of the surgeries were completed successfully with no conversions to an open or other laparoscopic surgical approach. FDA determined that the submitted data, along with the preclinical data and defined special and general controls for the system, provide a reasonable assurance of safety and effectiveness for the device.
The Hogan Lovells team for Memic included Washington D.C.-based Medical Device regulatory partners Jonathan Kahan and Lina Kontos.
For more information, please see press releases from Memic and FDA.