Posts by cstephenson@legacymedsearch.com
CoapTech to Initiate Clinical Trial for its PUMA-G Peds System for Pediatric Gastrostomy
CoapTech, Inc, a medical device company focused on delivering transformative solutions for minimally-invasive surgery, announced it has received an Investigational Device Exemption (IDE) approval from the Food and Drug Administration (FDA) to initiate a clinical trial for its PUMA-G Peds System, a device designed to provide a safer and more efficient way to place feeding tubes in…
Read MoreEchosens Launches FibroScan GO, Affordable State-of-the-Art, Non-Invasive Solution for Identifying Patients with Advanced Chronic Liver Disease
Echosens, a high-technology company offering the FibroScan® portfolio of solutions, is pleased to announce the launch of FibroScan GO, an affordable, cost-effective tool for screening liver health, improving liver health management at the point of care for primary care practices and reducing the flow of patients in secondary care centers. FibroScan GO is a solution for…
Read MoreLazurite™ to Showcase its ArthroFree™ Wireless Camera System at Multiple Upcoming Conferences
Medical device and technology company Lazurite Holdings LLC announced that its ArthroFree™ wireless camera system for minimally invasive surgery will be available for viewing and hands-on demonstration at these four upcoming medical conferences: Annual Meeting of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), March 16-19, in Denver (Booth 202) Global Surgical Conference & Expo…
Read MoreValencia Technologies Gains FDA Approval of eCoin® Therapy to Treat Urinary Urge Incontinence
Valencia Technologies Corporation, a privately held company, announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of its eCoin® leadless tibial neurostimulator for the treatment of urinary urge incontinence (UUI), which affects over 60% of patients who suffer from Overactive Bladder (OAB). FDA approval was supported by the efficacy and favorable…
Read More4WEB Medical Launches Hyperlordotic Lateral Implant Portfolio
4WEB Medical, an orthopedic device company focused on developing innovative implants with an Advanced Structural Design utilizing its proprietary Truss Implant Technology™, announced the company’s launch of a comprehensive array of hyperlordotic lateral implants. The first procedure was performed by Brad Prybis, MD, a surgeon at Tanner Medical Center in Carollton, GA. “The application of 4WEB’s…
Read MorePatenSee’s Contactless Imaging Device Shows Promise in Monitoring Dialysis Patients
The interim results of an ongoing clinical study of PatenSee‘s contactless imaging device for the early detection of vascular access stenosis for dialysis patients were shared in a poster presentation. The presentation, titled First Clinical Experience with Non-Invasive, Contactless, Optical Surveillance of Vascular Access, was delivered by the study’s principal investigator, Professor Benaya Rozen-Zvi, MD at the 2022 World…
Read MoreEvoEndo Announces US FDA 510(k) Clearance for their Single-Use, Unsedated Transnasal Endoscopy System
EvoEndo®, Inc. (“EvoEndo”), a medical device company developing systems for Unsedated Transnasal Endoscopy (TNE), has announced the receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) to begin marketing and sale of the EvoEndo® Single-Use Endoscopy System. The clearance follows EvoEndo’s distribution agreement with Micro-Tech Endoscopy USA, Inc. (“Micro-Tech”), which will begin…
Read MoreRapid Medical Granted FDA Breakthrough Device Designation for Vasospasm Treatment
Rapid Medical’s Comaneci is the first device that allows physicians to monitor vessel expansion, apply incremental adjustments, and enhance treatment with combination therapeutics. With this unprecedented control, the FDA designated Comaneci as a breakthrough device–offering advantages over existing technology to improve safety and efficacy in cerebral vasospasm. Rapid Medical, a leading developer of advanced neurovascular…
Read MoreImperative Care Launches Its Zoom POD™ for Stroke Treatment, the First and Only Filter to Capture Clot in the Sterile Field
Imperative Care, Inc. announced the launch of its Zoom POD™ Aspiration Tubing, the company’s latest innovation in elevating stroke care. The Zoom POD is the newest addition to Imperative Care’s Zoom Stroke Solution™, the company’s ischemic stroke product portfolio that includes the Zoom 88 Large Distal Platform for neurovascular access, four Zoom Aspiration Catheters in various…
Read MoreFirst Hospital on the East Coast to Perform Total Knee Replacement with THINK Surgical’s Next-Generation Robot System
Hackensack University Medical Center, a national leader in orthopedic care and robotic surgery, recently completed the first total knee replacement on the East Coast using the newest generation of the TSolution One robot from THINK Surgical. The system, manufactured by the Fremont, CA – based company features a true, active robot which supports a choice of knee implants…
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