Canary Medical has received breakthrough device designation from the US Food and Drug Administration (FDA) for its smart spine device, Canturio Lumbar Cartridge (canturio lc).
Featuring the Canary Health Implanted Reporting Processor (CHIRP) System, the cartridge is designed for lumbar spinal fusion.
canturio lc is used with a Lumbar Interbody System for lumbar spinal fusion from L1-S1.
Its design enables the collection of objective kinematic data from the implanted medical device, which is crucial for monitoring the progression of fusion and detecting any significant instability, partial fusion, or non-fusion post-surgery.
Similar to the Canturio Tibial Extension, the canturio lc is engineered to gather various kinematic measures for at least ten years.
The data collected from multiple parameters across the patient population will be pooled to provide a comprehensive overview of patient recovery.
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Canary’s data platform is set to offer frequent, objective aggregate population data to clinicians, allowing them to compare each patient’s recovery progress against their peers based on age, gender, and time since surgery.
This data will be instrumental in augmenting in-office examinations and updating care plans within the year following surgery.
Canary Medical founding member and CEO Bill Hunter said: “The approval of canturio lc is the fourth time in a row that a Canary Medical product has received breakthrough device designation from the FDA, an unparalleled accomplishment in our industry.
“First, we received breakthrough designation for our smart knee, followed by hip and shoulder applications, and now, our smart spine application.”
The announcement follows Canary Medical’s recent FDA clearance of the Canturio Smart Extension (canturio se), which is a 30mm smart tibial stem extension integrated with Zimmer Biomet’s Persona IQ – The Smart Knee.
In February, Canary completed the first-in-human clinical trial of its Cardiac Auscultation monitoring sensor device.
