Surgical Laparoscopy Articles & Analysis
9 news found
NMPA clearance expands global Phase 3 clinical development program; Company recently announced clearance from U.S. Food and Drug Administration to commence Phase 3 study Newsoara to fully fund Phase 3 program in China Under the Co-Development Agreement, commencement of Phase 3 program in China will trigger milestone payment to Palisade Bio Palisade Bio (Nasdaq: PALI), a clinical stage ...
Distalmotion, Revival Healthcare Capital and 415 CAPITAL announce the closing of a USD 90 million Series E financing round to accelerate the adoption of Distalmotion’s surgical robot Dexter. The investment follows Dexter’s successful initial clinical use and supports Distalmotion’s international commercial scaling. More than capital: A partnership of medtech pioneers and ...
Expanded Global ISU Machine Vision Capabilities In September, the Company announced that it received 510(k) clearance from the FDA for an expansion of machine vision capabilities on the previously cleared Intelligent Surgical Unit (ISU). The ISU is utilized with the Company’s Senhance Surgical System which enables Digital Laparoscopy. ...
The Senhance Surgical System is powered by the Intelligent Surgical Unit™ (ISU™). ...
New View Surgical, Inc., a medical device company developing proprietary imaging and access technologies for minimally invasive surgery (MIS), announced today that it received 510(k) clearance from the U.S. Food and Drug Administration for its VisionPort™ System. The VisionPort™ imaging and access system simplifies laparoscopic procedures for hospitals and provides surgeon-controlled ...
Senhance goes beyond the typical surgical robotic systems, providing surgical assurance through haptic feedback, eye-tracking camera control, and 3D visualization, and is the first platform to offer 3 mm instruments (the smallest instrument available in the world on a robotic surgical platform). ...
Patient reported no post-procedure pain and resumed regular activity day after procedure Connecticut-based medical device innovator Lumendi, LLC reports the first endoscopic appendectomy using its DiLumenTM Endolumenal Interventional Platform (EIP). A patient underwent the purely endoscopic endolumenal appendectomy to remove a lesion previously identified at the appendiceal orifice. ...
Connecticut-based medical device innovator Lumendi, LLC (http://www.lumendi.com) has announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the DiLumen Ik™ Endolumenal Interventional Knife, a sterile, single-use, disposable monopolar electrosurgical device for cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures. ...
FDA 510(k) clearance for removal of soft tissue by vaporization offers additional utility for surgeons ROSWELL, Ga. – May 1, 2013 – Plasma Surgical, creator of the PlasmaJet®, an advanced energy medical device designed as a safe and effective alternative to traditional electrosurgery instruments, announced today that it has received 510(k) clearance from the U.S. Food and Drug ...