Cardiology Radiology Surgery

Next-Gen TherOx SuperSaturated Oxygen Delivery System FDA Approved

Released on April 1, 2020

ZOLL Medical, now a part of Asahi Kasei Group, won FDA approval for the latest version of its TherOx System. The […]

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FDA Robotics Surgery

Neocis seeks 510(k) nod for Yomi edentulous splint for robotic dental surgery

Released on March 30, 2020

Neocis announced today that it filed for FDA 510(k) clearance for its Yomi edentulous splint to aid its dental robotic surgical system. […]

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Implants Orthopedic Surgery

Conformis Faced with Tough Decision to Furlough One-Third of Its Workforce

Released on March 24, 2020

Conformis is furloughing one-third of its workforce citing a sharp decline in elective procedures because of the novel coronavirus (COVID-19). In […]

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Orthopedic Spine Surgery

Precision Spine launches SureLOK MIS 3L percutaneous screw system

Released on March 23, 2020

Precision Spine has nationally launched the SureLOK MIS 3L percutaneous screw system in the USA. The SureLOK system can be used […]

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Neuro Orthopedic Surgery

SX-One MicroKnife Makes Carpal Tunnel Release a Minimally Invasive Procedure: Interview with CEO Dr. Darryl Barnes

Released on March 20, 2020

Carpal tunnel syndrome is a fairly common diagnosis in the United States, affecting approximately three to six percent of adults. Symptoms […]

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Healthcare Surgery

CMS urges hospitals to put off elective procedures

Released on March 19, 2020

Dive Brief: CMS on Wednesday night issued new recommendations urging hospitals to delay non-essential elective surgeries to be more prepared for […]

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FDA Cleared Robotics Surgery

TransEnterix Receives FDA Clearance for Intelligent Surgical Unit

Released on March 18, 2020

TransEnterix announced that it received FDA 510(k) clearance for its Intelligent Surgical Unit (ISU), a system that enables machine vision capabilities […]

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FDA Cleared Robotics Surgery

TransEnterix nets FDA clearance for AI vision-guided surgery

Released on March 13, 2020

TransEnterix received an FDA clearance for its “digital surgical assistant,” which it describes as the first machine vision system for robotic […]

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Ophthalmology Pediatrics Surgery

Sight Sciences Announces Publication of First-Ever Multicenter MIGS study in Childhood Glaucoma

Released on March 10, 2020

Results of independent clinical study of OMNI® predecessor system conducted by leading U.S. pediatric glaucoma specialists published in American Journal of […]

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FDA Surgery

FDA updates guidance on 510(k) submissions for electrosurgical devices

Released on March 10, 2020

Dive Brief: FDA on Monday issued an updated guidance advising manufacturers on how to prepare 510(k) submissions for electrosurgical cutting and […]

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MedTech Surgery

ECRI: Poor sterilization, failure to learn from device problems threaten patient safety

Released on March 10, 2020

Dive Brief: Properly investigating problems with medical equipment along with better cleaning, disinfecting and sterilizing of devices are among low-hanging fruit […]

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Cardiology FDA Approved Pediatrics Surgery

Masimo Receives FDA Approval for Continuous RRp Monitoring

Released on March 9, 2020

Masimo announced that it received FDA clearance for continuous RRp (respiration rate from the photoplethysmograph) monitoring with its with Rad-97, Radical-7, […]

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