medical device guru

Surgery and Surgical Robotics

Preceptis Medical Receives FDA Clearance for Expanded Labeling for Hummingbird System

Preceptis Medical, Inc., an innovative surgical technology company dedicated to providing less invasive options for pediatric patients, announced U.S. FDA clearance for expanded indications for use for the Hummingbird® Tympanostomy Tube System (TTS) for office-based pediatric ear tube procedures. Previously...

August 17, 2022

Surgery and Surgical Robotics

ClearPoint Neuro Announces FDA Clearance for ClearPoint Maestro™ Brain Model

ClearPoint Neuro, Inc., a global therapy-enabling platform company providing navigation and delivery to the brain, announced it has received 510(k) clearance for its ClearPoint Maestro™ Brain00 Model. Maestro is intended for automatic labeling, visualization, volumetric and shape quantification of segmentable...

August 15, 2022

Surgery and Surgical Robotics

Cognito Therapeutics Announces Proprietary Gamma Sensory Stimulation for 6-Months Reduces White Matter Atrophy in Alzheimer’s Disease Patients

Cognito Therapeutics, announced that its proprietary gamma sensory stimulation at 40Hz over a 6-month period reduced white matter atrophy in the brain for patients with Alzheimer’s Disease, according to new data presented at the Alzheimer’s Association International Conference 2022. Alzheimer’s...

August 2, 2022

Surgery and Surgical Robotics

Rapid Medical Gains FDA Clearance for the Smallest & Only Adjustable Thrombectomy Device

Rapid Medical, a leading developer of advanced neurovascular devices, announces FDA 510(k) clearance for TIGERTRIEVER™13 for large vessel occlusions at the 2022 Society of NeuroInterventional Surgery’s (SNIS) 19th Annual Meeting in Toronto. TIGERTRIEVER 13 is the smallest revascularization device in the world...

July 27, 2022

Surgery and Surgical Robotics

Samsara Vision Announces First U.S. Surgeries of the SING IMT™ (Smaller-Incision New-Generation Implantable Miniature Telescope), for Age-Related Macular Degeneration as part of the CONCERTO Study

Samsara Vision, a company focused on bringing vision and freedom back to patients with late-stage, age-related macular degeneration (AMD) through advanced visual prosthetic devices, announced the completion of the first U.S. surgeries of its SING IMT™ (Smaller-Incision New-Generation Implantable Miniature...

July 11, 2022

Surgery and Surgical Robotics

Centerline Biomedical Raises $33 Million in Series B Financing

Centerline Biomedical, Inc. (Centerline), a private medical technology company, announced the closing of a $33 million Series B equity financing led by Cleveland Clinic with participation by GE Healthcare, RIK Enterprises, JobsOhio, Jumpstart Ventures and G2 Group Ventures. This funding will help...

June 27, 2022

Surgery and Surgical Robotics

Lumendi Files for FDA 510(k) Clearance for Two New Products

Lumendi, LLC has announced it has filed for U.S. Food and Drug Administration (FDA) 510(k) clearance for DiLumen EZ¹, a single-use, disposable endotherapy device intended for endoscopic mucosal resections (EMR) and difficult colonoscopies. The new design, based on the long-standing...

May 24, 2022

Surgery and Surgical Robotics

Article Reviews the Evolution of Arthroscopy from its Invention in 1912 to the Dawn of the Wireless ArthroFree™ Era

A recent history of arthroscopy by Dr. James S. Williams, Jr., and Dr. Asheesh Gupta reports that while there have been numerous incremental advances in arthroscopic camera technology over the last half-century, the current systems remain largely unchanged. Surgeons are...

May 23, 2022

Surgery and Surgical Robotics

Limaca Medical Receives FDA Breakthrough Device Designation

Limaca Medical (“Limaca”) announced that its Precision-GI™ Endoscopic Ultrasound Biopsy Product has received a Breakthrough Device Designation from the U.S. Food and Drug Administration (“FDA”). The Precision-GI™ device is designed to obtain tumor tissue within or adjacent to the gastrointestinal tract....

May 13, 2022