Aurora Surgiscope System for Minimally Invasive Neurosurgery Receives FDA Clearance

OrthoNext Digital Platform for the JuniOrtho Plating System Receives FDA Clearance

“Together, OrthoNext and the JuniOrtho Plating System provide a complete solution for surgeons looking for a plating system to address the specific demands of advanced deformity and trauma reconstruction of the lower extremities in the pediatric population,” said Orthofix President of Global Orthopedics Paul Gonsalves.

SonarMed, New Pediatric Monitor Alerts Clinicians To Potential Airway Obstructions During Ventilation Launched

"The SonarMed airway monitoring device has revolutionized the way we care for our littlest patients. There is no other device in the world that can tell you where the endotracheal tube is located within the airway continuously in real-time, and whether the tube is obstructed or even partially occluded," said Jamie W. Powers, M.D., MBA, neonatologist at Huntington Hospital in Pasadena, California.

Rebound Therapeutics® Corporation today announced FDA 510k clearance of their AURORA Surgiscope® System, the world’s first single-use disposable Neurosurgical Endoscope for minimally invasive access, visualization and illumination of the target neuro anatomy. The Aurora Surgiscope System consists of two components: the sterile, single use, neurological endoscope called the Aurora Surgiscope and the non-sterile, reusable control unit called the Image Control Box. The Surgiscope has a large working channel to optimize minimally invasive surgery, and the Image Control Box allows the user to digitally control the high definition video image.

Rebound President and CEO Jeffrey Valko commented, “Our physician advisors specified that we enable the complete neurosurgical procedure, without reliance on any third-party component, to keep the procedure minimally invasive, simple and without expensive capital equipment. A significant opportunity exists to decrease operating room setup time, eliminate risk of infections from re-sterilizing reusable devices, and to reduce procedural cleanup and operating room turnaround time. We’ve integrated state-of-the-art visualization and illumination technology into an easy to use device, compatible with current operating room high definition flat panel displays.”

University of Buffalo Neurosurgeon Adnan Siddiqui, MD commented, “Minimally invasive neurosurgery to date seems to be dependent on multiple pieces of complex and expensive capital equipment. In my mind, minimally invasive should be simple, focused on ease-of-use not only for the surgeon but also for the operating room staff without compromising safety or effectiveness. Rebound has uniquely created an innovative technology that meets these criteria. I have used the Rebound AURORA Evacuator with great satisfaction, and I’m excited to use the AURORA Surgiscope. The AURORA System represents a new class of technology that should simplify neurosurgical procedures, reduce risk and enhance the patient’s chance for improved quality of life.”

spot_img

DON'T MISS

Subscribe to Medical Device News Magazine here.

Related Articles