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The U.S Food and Drug Administration granted a De Novo review for a device intended to be used in the spine.
The LOADPRO Intraoperative Rod Strain Sensor is a digital health device that can measure the mechanical strain on rods in a pedicle screw system. In April 2015 Intellirod Spine retained MCRA to play a leading role in the interactions with the FDA
“This is an important instrument that now allows surgeons to quantify the rod strains as rods are contoured and loaded to correct the patient's deformity, whereas surgeons currently rely on tactile feedback. Working with MCRA was an essential element in the successful navigation through the De Novo process,” said Intellirod Spine's president and chief executive officer Ric Navarro.
MCRA, a leading clinical research organization and advisory firm in the medical device and biologics industry, is at the forefront of helping companies navigate the regulatory landscape.
“We are pleased the collaboration with FDA led to the De Novo pathway, which prompted a detailed review of the device's positive benefit-risk profile that was highlighted by the clinical experiences and innovative testing designed by Intellirod Spine that sets an important bar for future technologies to demonstrate they are as safe and effective.” Justin Eggleton, vice president of spine regulatory affairs at MCRA, said. “MCRA is at the forefront of helping companies navigate this regulatory pathway and successfully bring novel devices to the U.S. market that will benefit surgeons and their patients.”
