Asensus Surgical scores general surgery clearance for its Senhance robot
Shortly after TransEnterix changed its name to Asensus Surgical late last month—calling the rebranding a signal of its plans to bring artificial intelligence to...
FDA clears first surgical robot for transvaginal hysterectomies
The FDA cleared its first surgical robot designed for transvaginal hysterectomies, a minimally invasive option that aims for a faster recovery time compared to...
Fusion Robotics™ Receives 510(k) Clearance for Spinal Navigation & Robotics System
Fusion Robotics LLC, a spinal robotics and navigation company today announced receiving 510(k) clearance to market their 3D imaging compatible navigation and robotic targeting...
J&J’s Covid-19 vaccine gets vote of confidence from FDA advisory panel
The committee voted 22-0 on the question of whether the benefits of Johnson & Johnson's Covid-19 vaccine outweigh its risks. FDA emergency use authorization...
Gala Therapeutics Receives FDA Approval to Commence Pivotal Trial to Evaluate the RheOx™ System for Chronic Bronchitis
Gala Therapeutics, Inc. (Gala), a developer of medical devices to treat pulmonary disease, announces U.S. Food and Drug Administration (FDA) conditional Investigational Device Exemption...
Brainlab Loop-X Mobile Imaging Robot and Cirq Robotic Alignment Module for Spine Both Receive FDA clearance
Brainlab announced today that the company has reached two major milestones with the FDA clearance for both Loop-X® Mobile Imaging Robot and Cirq®, a robotic...
AI-based voiceprint screener for COVID-19 nets European approval
From taste and smell to muscle aches and “COVID toes,” the coronavirus affects the body in a variety of ways—including small changes in a...
OpSens Obtains CE Marking for the OptoWire III
OpSens Inc. ("OpSens" or the "Company") (TSX: OPS) (OTCQX: OPSSF), a medical device cardiology-focused company commercializing a second-generation fiber optic pressure guidewire to diagnose and treat coronary...
Infant monitoring tech brand Owlet announces SPAC merger for Q2 2021
The company currently sells connected wearables and smart monitors to consumers but said that it will be seeking FDA authorization for new products with...