Food & Drug Administration

Virtual Incision said it has received an investigational device exemption for it Miniaturized In Vivo Robotic Assistant, or MIRA, platform for minimally invasive colon resection surgery.

Neocis, which makes robotic software and systems for guiding dental surgical procedures, has received FDA approval for Yomi treatment of full arch implants in addition to partial endentulous cases.

Miso Robotics, creator of the Flippy burger-flipping robot, has partnered with PathSpot Technologies to bundle PathSpot’s hand-scanning technology to improve food and worker safety.

TransEnterix’s newly approved Intelligent Surgical Unit enables augmented intelligence for the Senhance laparoscopic surgical system.

TransEnterix’s new technology is designed to enable augmented intelligence with its Senhance system for robot-assisted surgery.

The Sport surgical system, which is intended for minimally invasive gynecological procedures, has been put on hold as Titan Medical looks for more money for R&D and regulatory submissions.

Think Surgical enters a competitive orthopedic surgery market with U.S. approval for the use of its TSolution One surgical robot for total knee replacement.

Titan Medical has delayed plans for submitting its Sport robotic surgical system to work on further development and funding.

Corindus Vascular Robotics, whose CorPath GRX has FDA approval for percutaneous coronary and vascular procedures, will be acquired by Siemens Healthineers.

Myomo is working with contract manufacturers for its MyoPro assistive devices, which use sensors, algorithms, and motors to help wearers regain upper-limb function.

Robot-assisted surgery is growing, as new technology enables applications for additional operations. AdventHealth for Women in Florida is an early user of TransEnterix’s Senhance for gynecological procedures.

Boston researchers recently demonstrated a robotic catheter that could autonomously navigate through the body to repair a cardiac valve.

Attendees and speakers at a food robotics event in San Francisco discussed the biggest challenges facing developers and users of robots and AI for cooking, delivery, and tracking.

Intuitive Surgical won another indication from the Food and Drug Administration (FDA) for its da Vinci SP robot-assisted surgery device. The Sunnyvale, Calif.-based company said the FDA added single-port radical tonsillectomy and tongue base resection procedures to the mix. Initially cleared in April 2014 for urological procedures, in June 2018 the federal safety watchdog added a clearance…

Keynotes | Speakers | Exhibitors | Register The U.S. Food and Drug Administration (FDA) has issued a warning against the use of surgical robots in mastectomies and other surgeries for the treatment or prevention of cancer. The FDA said the safety and effectiveness of surgical robots have not been established for use in mastectomies or…

Intuitive Surgical Inc. yesterday said that the U.S. Food and Drug Administration approved its Ion system. The robotic endoluminal system is designed to enable doctors to conduct minimally invasive biopsies deep within the lung. Ion includes an articulating robotic catheter with an outer diameter of only 3.5 mm that is able to move 180 degrees in…

Corindus Vascular Robotics this week said it applied to the U.S. Food and Drug Administration for premarket clearance to use its CorPath GRX robotic surgical platform in neurovascular interventions. The Waltham, Mass.-based company has already received FDA clearance for percutaneous coronary interventions (PCI), which it won in 2016, and for peripheral vascular interventions (PVI), which it won last…

TransEnterix has won expanded indications from the Food and Drug Administration for its Senhance robot-assisted surgical system. The system is now cleared for hernia and gallbladder procedures. There are approximately 760,000 inguinal hernia and 1.2 million laparoscopic cholecystectomy procedures performed annually in the U.S. With this clearance, the system’s total addressable annual procedures in the…

Auris Health, previously known as Auris Surgical Robotics and formed by Intuitive Surgical (NSDQ:ISRG) founder Dr. Frederic Moll, won FDA clearance for its Monarch robotic endoscopy platform. The Redwood City, Calif.-based company said it’s Monarch robotic platform’s initial aim will be on treating lung cancer, with the FDA clearance indicating the device for use in…

It was the last question of the night, and it hushed the entire room. An entrepreneur expressed his aggravation about the US Food and Drug Administration’s (FDA) antiquated regulatory environment for AI-enabled devices to Dr. Joel Stein of Columbia University. Stein, a leader in rehabilitative robotic medicine, sympathized with the startup, knowing that tomorrow’s exoskeletons…

Renishaw, a British engineering company, received approval by federal officials to sell the latest version of its neurosurgery planning software in the U.S. The FDA granted 510(k) clearance for Renishaw’s neuroinspire software that blends MRI and CT datasets into a 3D volume, enabling neurosurgeons to identify and outline regions of interest. The approach is designed…

Share prices for TransEnterix (NYSE:TRXC) have more than doubled since the robot-assisted surgery company won an important clearance from the FDA last week and CEO Todd Pope is optimistic about his companies chances against the undisputed market leader, Intuitive Surgical (NSDQ:ISRG). Morrisville, N.C.-based TransEnterix, which acquired Senhance for $100 million in September 2015, finalized its clearance bid last…