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Home/Large Joints and Extremities/FDA Clearance Received for Physical Therapy Tool
Large Joints and Extremities

FDA Clearance Received for Physical Therapy Tool

By Bilione W. YoungNovember 11, 2015 1 min read Premium comments

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FDA Clearance Received for Physical Therapy Tool
Courtesy of Reflexion Health
Secondary

Reflexion Health’s physical therapy tool, called Vera, is the latest digital health device to receive FDA clearance, according to Stephanie Baum, writing for MedCity News. The CEO and co-founder of Reflexion Health, Spencer Hutchins, said that the purpose of the new device is to transform physical therapy at home from a black box to quantifiable data that can be tracked and shared.

The device’s focus is on hip and knee replacements, most especially those performed in the system of bundled payments. Under this program several facilities and individuals must track progress and demonstrate improved patient outcomes in order to get paid. The bundled payment program extends to 90 days following the joint replacement surgery.

“That put jet fuel on our value proposition, ” Hutchins said. “There are 1 million hips and knees replaced each year. We want to transform the way rehabilitation medicine is practiced. It involves a data driven approach that treats patients like core members of their care.”

The median age of patients having hip and knee replacement surgery is 66 – 67. Hutchins is convinced that seniors can successfully learn from and interact with a digital health care platform. He said, “We need to bring connectivity to get data to flow. We have a wide cohort of patients that are not tech savvy, but we found that being thoughtful about training, and how it implemented the interactive, motion-led program made a big difference in engagement.”

Hutchins contends that the paper diagrams given to patients as guidance for physical therapy are confusing and unproductive. “We’re of the belief that to fundamentally change medicine, you have to bring more consumer focus into practices, but you can’t just ignore the delivery systems in place.”

Author

BW
Bilione W. Young
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Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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