FDA Grants RenovaCare Full IDE Approval for Safety and Feasibility Clinical Trial
RenovaCare, Inc., announced that its Investigational Device Exemption (IDE) application has been granted full approval by the U.S. Food and Drug Administration (FDA). This...
EYEMATE System for Remote Glaucoma Management Obtains FDA Breakthrough Device Designation
HANNOVER, Germany and SAN DIEGO, CA, April 28, 2021 / B3C newswire / -- Implandata Ophthalmic Products, a digital health company with offices in Germany...
Pixee Medical Receives FDA Clearance for Knee+
Pixee Medical received FDA 510(k) clearance to market its Knee+ AR computer assisted orthopedic solution.Knee+ is designed to help orthopedic surgeons perform surgeries better...
Neurolutions Receives U.S. Food and Drug Administration De Novo Market Authorization for IpsiHand™ Upper Extremity Rehabilitation System
IpsiHand exoskeleton uniquely leverages brain-computer interface technology for chronic stroke rehabilitationIpsiHand also has been granted U.S. FDA Breakthrough Device DesignationNeurolutions, Inc., a medical device company...
Edge Surgical wins patent for spinal surgery tech
EDGe Surgical, Inc., a company focused on developing and manufacturing smart orthopedic and spine surgical instruments, announced today that its next-generation Awl-in-One Tap™ device...
Cerus Endovascular Announces IDE Approval from the U.S. FDA to Conduct Clinical Study of the Contour Neurovascular System™
Patient Enrollment to Begin Within Three MonthsCerus Endovascular Ltd., a privately held, commercial-stage medical device company, today announced that the U.S. Food and Drug...
Zimmer Biomet Secures FDA Clearance for ROSA® Partial Knee System
ROSA® System is used for Robotically-Assisted Partial Knee Arthroplasty.Leader in musculoskeletal healthcare, Zimmer Biomet, has received FDA 510(k) clearance of the ROSA® Partial Knee System for...
Empatica gets CE mark for EmbracePlus medical smartwatch
A medical smartwatch for researchers and healthcare providers to collect continuous and objective data from patients, while enabling health monitoring at scale. EmbracePlus by Empatica has...
OncoSec Receives CE Mark Certification for its Commercial Electroporation Device “GenPulse™” for the Treatment of Solid Tumors
CE mark enables commercialization of GenPulse™ in EUOncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec"), a biotechnology company focused on cytokine-based intratumoral immunotherapies, announced...