medical device guru

Surgery and Surgical Robotics

CereVasc Receives FDA IDE Approval to Expand its Clinical Study of Patients with Normal Pressure Hydrocephalus Utilizing the Generation 2 eShunt® System

CereVasc, Inc., a clinical-stage, medical device company developing novel treatments for neurological diseases, announced that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) supplement to permit the expansion of the study of the eShunt...

September 18, 2023

Surgery and Surgical Robotics

Levita® Magnetics Wins FDA Clearance for Pioneering MARS™ System

Levita Magnetics, whose mission is to help more patients get access to better surgery, announced today it has received U.S. Food and Drug Administration (FDA) clearance for its MARS™ platform. The Levita MARS system is a first-of-its-kind minimally invasive surgical...

August 22, 2023

Surgery and Surgical Robotics

FluidAI’s artificial intelligence-powered postsurgical monitor, Stream™ Platform, launches globally

Canadian medical technology company, FluidAI Medical (FluidAI), is set to revolutionize postoperative care with the launch of its ground-breaking medical device, the Stream™ Platform in Canada and Saudi Arabia. Through the use of the Stream™ Platform, surgeons have the potential to make a more accurate...

August 9, 2023

Surgery and Surgical Robotics

Iotamotion Completes $12m Series A Raise to Accelerate Commercial Expansion of IotaSOFT® Insertion System

iotaMotion, Inc., a leader in developing advanced robotic-assisted systems for cochlear implant surgery, announced today the company has oversubscribed its $12 million Series A capital raise. The company closed the round with support from a select group of venture capital firms, private...

July 26, 2023

Surgery and Surgical Robotics

UroMems Announces First-Ever Smart Artificial Urinary Sphincter Implant in a Female Patient

UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-ever implant of the UroActive™ smart, automated artificial urinary sphincter (AUS) in a female patient. This milestone indicates a new...

July 21, 2023

Surgery and Surgical Robotics

Francis Medical Announces First Patient Treated in VAPOR 2 Pivotal Study for Water Vapor Ablation of Prostate Cancer

Francis Medical, Inc., a privately held medical device company developing an innovative and proprietary water vapor ablation therapy for the treatment of prostate, kidney, and bladder cancer, today announced the first patient has been treated in the company’s VAPOR 2...

July 19, 2023

Surgery and Surgical Robotics

MedRhythms Announces FDA Listing of InTandem™ (MR-001) to Improve Walking and Ambulation in Adults with Chronic Stroke

MedRhythms announced that MR-001, the company’s evidence-based neurorehabilitation system to improve walking and ambulation in adults with chronic stroke walking deficits, has been listed as a Class II medical device with the U.S. Food and Drug Administration (FDA). The system...

July 6, 2023

Surgery and Surgical Robotics

USMI Receives FDA Approval for New Robotic Surgery Device – The Canady Flex RoboWrist™

US Medical Innovations, LLC (USMI), a Biomedical and Life Science subsidiary of US Patent Innovations, LLC, announced today it has received FDA Approval for its Canady Flex RoboWrist™ to be used in open and laparoscopic procedures in the United States....

June 29, 2023

Surgery and Surgical Robotics

Surmodics Receives FDA 510(k) Clearance for Pounce™ LP Thrombectomy System

Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pounce™ LP (Low Profile) Thrombectomy System. Introduced in 2021, the Pounce...

June 14, 2023