eXciteOSA
Authors: Tejas Nikumbh MD, Nova Szoka MD, FACS, FASMBS Signifier Medical Technologies received FDA approval by the DeNovo pathway for the eXciteOSA neuromuscular tongue stimulator in February 2021. The eXciteOSA is a removable device that delivers neuromuscular stimulation to the tongue to reduce snoring and mild obstructive sleep apnea. Treatment takes twenty minutes a day […]
Ethicon Megadyne™ Electrosurgical Generator
Ethicon received FDA approval for the Megadyne Electrosurgical Generator K213696 on January 21, 2022. The Megadyne™ Electrosurgical Generator K213696 is new iteration in the line of Ethicon Megadyne™ Electrosurgical Generators. It is intended to be used as a general-purpose electrosurgical generator for use in a wide variety of both open and laparoscopic procedures. It is […]
PK Electrosurgical Instruments: PK Needle, PK Spatula, and PK J-Hook
Olympus received FDA approval for PK Electrosurgical Instruments: PK Needle, PK Spatula, and PK J-Hook on January 4, 2022. The PK Electrosurgical Instruments, including Needle, Spatula, and J-Hook are classified as electrosurgical cutting and coagulation surgical devices and accessories. These impedance controlled devices are compatible with the Olympus ESG-400 and ESG-410 generators. These devices decrease […]
Ambu® aScope™ Gastro and Ambu® aBox™ 2
Ambu® aScope™ is a sterile single-use gastroscope which was released in conjunction with Ambu® aBox™ 2, a next-generation display with advanced processing technology offering high quality images during endoscopic procedures. In 2005, the American College of Chest Physicians published a consensus statement on the Prevention of Flexible Bronchoscopy-Associated Infection.1 Since then, there has been a […]
Author(s): Matthew Burstein, MD, PhD, Marissa Novack, MD, Alan Posner, MD Human Xtensions Ltd. received FDA approval for the HandX Monopolar Hook on February 1, 2021 (K203603). The HandX platform allows for motorized 85 degree articulation across 4 degrees of freedom, and up to 540 degrees of rotation through conventional 5 mm laparoscopic ports, directly […]
Author(s): Kevin Carroll, MBBS, David Pechman, MD Boston Scientific received FDA approval for the EXALT Model B Single-Use Bronchoscope on August 10th, 2021 The EXALT Model B Bronchoscope is a single-use bronchoscope developed as an alternative to reusable bronchoscopes. This bronchoscope has superior quality imaging and suctioning (up to 78% improved) which is vital for […]
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. Â 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 […]