medical device guru

Surgery and Surgical Robotics

Medtronic Warns of Mazor X Detachment Issue in Robotic Surgery

Users of Medtronic’s Mazor X Surgical System may experience a hardware detachment problem in which a system piece unexpectedly releases from the OR table, according to an urgent field safety notice issued by the company in December. Medtronic said it had received...

January 7, 2020

Surgery and Surgical Robotics

Interscope Announces New FDA Clearance of the EndoRotor, for Use in Airway Procedures Including in Interventional Pulmonology

Interscope, Inc. announced today the receipt of marketing clearance from the FDA for the EndoRotor® System to commercialize Pulmonary indications.  Interscope innovated the first flexible microdebrider for use by medical specialists in the digestive tract with reported results reducing the need...

January 2, 2020

Surgery and Surgical Robotics

Foresee-X Augment Reality Solution from SURGLASSES Is Registered with the FDA and Ready for Trauma Treatment

Foresee-X is a set of smart surgical glasses with functionality based on augmented and mixed reality technologies. This device was developed by SURGLASSES, also known as Taiwan Main Orthopaedic Biotechnology Co. Ltd., and has received IEC60601-1-2 and ISO 13485 certifications. It...

January 2, 2020

Surgery and Surgical Robotics

Augmedics Announces FDA 510K Clearance and U.S. Launch of xvision, the First Augmented Reality Guidance System for Surgery

Augmedics, a pioneer in augmented reality surgical image guidance, has announced U.S. Food and Drug Administration (FDA) 510(k) clearance and the U.S. launch of its groundbreaking xvision Spine system (XVS), the first AR guidance system to be used in surgery....

December 26, 2019

Surgery and Surgical Robotics

IRRAS Receives Renewed CE Mark for the IRRAflow Catheter

IRRAS, a global healthcare company with a comprehensive portfolio of innovative products for neurocritical care, announced today that it received CE Mark approval for its IRRAflow®catheter. This CE Mark complements the two CE Marks previously obtained for the IRRAflow system’s tube set with digital...

December 19, 2019

Surgery and Surgical Robotics

Medtronic Expands Surgical Synergy(SM) with FDA Clearance of the Stealth Autoguide System for Cranial Procedures 

Medtronic plc announced that the U.S. Food and Drug Administration (FDA) recently cleared the Stealth Autoguide™ system, the first cranial robotic platform that integrates with Medtronic’s enabling technology portfolio to create an end-to-end procedural solution. The Stealth Autoguide Platform is...

December 19, 2019

Surgery and Surgical Robotics

Aptar’s Nasal Unidose Device Approved by U.S. FDA for First Nasal Rescue Treatment for Frequent Seizure Activity 

AptarGroup, Inc., a global leader in drug delivery, consumer product dispensing and active packaging solutions, today announced that its patented Unidose Liquid System is the device delivering the first and only nasal rescue treatment approved by the U.S. FDA, which...

December 12, 2019

Surgery and Surgical Robotics

MolecuLight Receives FDA 510(k) Clearance for its i:X Handheld Fluorescence Imaging Device for Wound Management 

MolecuLight Inc., the world’s leader in handheld fluorescence imaging for real-time visualization of fluorescence in wounds, has received FDA 510(k) clearance for its i:X® handheld fluorescence imaging device for use in the detection of wounds containing bacteria. This FDA 510(k) clearance is...

December 10, 2019

Surgery and Surgical Robotics

Vicarious Surgical Wins FDA Breakthrough Designation for Surgical Robot

Vicarious Surgical Inc., the leading innovator in virtual reality and robotics for minimally invasive surgical treatments, announced today they were recently granted the Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). The FDA Breakthrough Devices Program is...

December 9, 2019