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Category: Food & Drug Administration

Robotics | IoT

Intuitive Surgical da Vinci SP robot wins clearance for new procedures

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…

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FDA warns about using surgical robots for cancer treatment

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…

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Ion lung biopsy system from Intuitive Surgical wins FDA approval

Intuitive Surgical Inc. yesterday said that the U.S. Food and Drug Administration has cleared 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…

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Corindus submits CorPath GRX to FDA for robotic neurovascular interventions

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…

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TransEnterix Senhance surgical robot gets approved for new procedures

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…

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Auris Health wins FDA approval for Monarch surgical robot

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…

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Regulatory challenges holding back healthcare AI

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…

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Renishaw wins FDA approval for neurosurgery planning software

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…

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TransEnterix CEO Pope, riding high on FDA nod, eyes the laparoscopic surgery market

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…

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TransEnterix wins FDA nod for Senhance robot-assisted surgery platform

TransEnterix (NYSE:TRXC) said last week that it won 510(k) clearance from the FDA for its Senhance robot-assisted surgery platform. TransEnterix, which acquired Senhance for $100 million in September 2015, finalized its clerarance bid last month after applying in April.  “The clearance of the Senhance system in the U.S. is a milestone in the progress of robotics and is…

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