MCRA, LLC has announced its role in the successful granting of the first De Novo for a device intended to be used in the spine by the U.S. Food and Drug Administration on March 28, 2019.
WASHINGTON, April 4, 2019 /PRNewswire/ -- MCRA, LLC has announced its role in the successful granting of the first De Novo for a device intended to be used in the spine by the U.S. Food and Drug Administration (FDA) on March 28, 2019. This accomplishment enables Intellirod Spine™ to initiate commercialization in the U.S. of the LOADPRO™ Intraoperative Rod Strain Sensor, which is a digital health device that objectively measures mechanical strain in the sagittal plane on rods in a pedicle screw system due to load applied to correct the spine curvature. This illustrates the growing trend in using digital health to improve healthcare.
Intellirod Spine™ retained MCRA in April of 2015 to lead interactions and correspondence 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 & Chief Executive Officer, Ric Navarro.
Justin Eggleton, Vice President of Spine Regulatory Affairs at MCRA, said, “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. 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.”
About MCRA, LLC
Founded in 2004, MCRA is a leading clinical research organization and advisory firm to the medical device and biologics industries. MCRA’s value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance, and quality assurance. MCRA’s integrated approach of these key value creating initiatives provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, and New York, NY, and serves more than 550 clients globally. MCRA has a demonstrated history of driving success in spine, orthopedics, cardiovascular, wound care, dental, general surgery, neurology, Section 361 human cell/tissue products, combination products, and biologics. www.mcra.com
About Intellirod Spine
Intellirod Spine™ (formerly OrthoData Inc.) was founded by renowned spine surgeon Rolando M. Puno, M.D. and professors from the University of Louisville. The company is developing multiple wearable, disposable and implantable wireless sensors for improving outcomes and lowering costs. This innovative strain monitoring system will allow spine surgeons to objectively assess intra-operative rod strain. www.intellirodspine.com
Contact
Email: info@mcra.com
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SOURCE MCRA, LLC
