GI Genius
Author(s): Justin Williams, Nova Szoka, MD, FACS, FASMBS Medtronic received FDA approval for the GI Genius in April 2021. The GI Genius is an artificial intelligence system used to aid in the detection of polyps and other precancerous lesions during routine colorectal screening. During screening colonoscopies, the GI Genius generates on-screen markers as well as […]
Standard Bariatrics® Titan SGS™ 230mm Linear Stapling Technology
Author(s): Matthew Burstein, MD and Aaron Hoffman, MD Standard Bariatrics received FDA clearance for the Titan SGS on April 28th, 2021 (K210278). The Titan SGS with implantable staples is a single patient use, laparoscopic sterile powered linear stapler used for cutting and stapling gastric tissue during sleeve gastrectomy. The stapler end effector is 230 mm […]
SPY Portable Handheld Imaging (SPY-PHI) System
Authors: Lilah Goldberg, Nova Szoka, MD, FACS, FASMBS Stryker received FDA approval for the SPY Portable Handheld Imaging (SPY-PHI) System in November 2019. The SPY-PHI is a handheld imaging device for performing intraoperative fluorescence angiography. After intravenous injection of indocyanine green dye, the SPY-PHI facilitates real-time capturing and viewing of fluorescent images for the visual […]
Aesculap Caiman Vessel Sealer
Aesculap received FDA approval for the Caiman 12 Seal and Cut Technology System on November 23, 2020. The device is a vessel sealer designed for laparoscopic or open surgery, utilizing bipolar electrosurgical radiofrequency (RF) energy. The instruments seal vessels by applying the energy to vessels or other tissue that is compressed between the jaws of […]
StitchKit® COMBO Suture Delivery Canister
Authors: Xavier Jean MD, Kate Lak MD Origami Surgical received FDA approval for the StitchKit® COMBO Suture Delivery Canister in February 2021. The StitchKit® COMBO Suture Delivery Canister is a device that assists in transporting suture to the operative field and removing needles after suturing in minimally invasive robotic surgery cases. This device allows passing of […]
Mirus Circular Stapler (Meril Endo Surgery Private Limited)
Meril Endo Surgery received FDA (United States Food and Drug Administration) approval for their Mirus Circular Stapler on February 5, 2021 The Mirus Circular Stapler is similar to existing implantable stapler devices used to create stapled gastrointestinal anastomoses and comes pre-loaded with staples for single-use application. The device simultaneously cuts and applies staples in a […]
EndoClot®- Polysaccharide Hemostatic System (PHS)
EndoClot Plus, Inc. (EPI) received clearance for the EndoClot® – Polysaccharide Hemostatic System (PHS) from the Food and Drug Administration (FDA) in January 2021. The EndoClot® PHS is a single use medical device consisting of Absorbable Modified Polymers (AMP®) and a specific powder delivery system (applicator). It is intended to control non-variceal bleeding in the […]
ActivSight Intraoperative Imaging System
Authors: Matthew D. Burstein, MD, PhD & Chibueze A. Nwaiwu, MD Activ Surgical, Inc. received FDA approval for the ActivSight Intraoperative Imaging Module on April 8, 2021 (K203550). The ActivSight Intraoperative Imaging Module installs between a standard laparoscope and white light camera system, with a separate proprietary “Light Engine” custom light source that combines white […]
da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments
Authors: Samir Narula, MD & Luca Milone, MD The da Vinci X/Xi (IS4200/IS4000) and da Vinci S/Si (IS2000/IS3000) EndoWrist Instruments, produced by Intuitive Inc, have a unique articulating design at their distal tips that mimics the human wrist. While seated at the console of the surgical system, the surgeon can precisely control movements of the […]
Hominis
Memic Innovative Surgery Ltd., Inc. received FDA approval for the Hominis® Surgical System on February 26th, 2021. The Hominis Surgical System is an endoscopic instrument control system intended to control the Hominis robotic arms for use during single site, natural orifice laparoscopic assisted benign transvaginal surgery. Intended uses include: salpingectomy, oophorectomy, adnexectomy, ovarian cyst removal, and […]