Edmonton, Alberta - June 1st, 2021
It was with great excitement that the Medo team received 510(k) FDA clearance for our Medo Thyroid software device. It is the second FDA clearance we’ve had in less than a year! The technology uses artificial intelligence to simplify thyroid ultrasounds for a simpler, quicker, and more accurate diagnosis. This breakthrough drastically simplifies diagnostic imaging workflows for health care professionals making it more accessible and accurate.
Given the rigor and thoroughness of FDA clearance, this milestone is incredibly validating to our underlying technology and product.
What is the FDA?
The FDA (United States Food and Drug Administration) is a federal agency of the Department of Health and Human Services, and it’s responsible for protecting American public health by ensuring the safety, efficacy, and security of health-related products. Which in Medo’s case, means medical image analysis platforms.
For a product to have FDA clearance, the agency had to have undergone a rigorous review process to determine whether the “benefits of a product outweigh the known risks for the intended use”. Medo needed to submit a lengthy premarket clearance application, as well as the results of our clinical testing in order to receive FDA clearance.
What does this mean for Medo?
Even prior to clearance, our technology had been vetted and tested by radiologists and sonographers in Canada and Singapore. With FDA clearance, our team can more aggressively look to deliver value to Thyroid users in the United States. This, in turn, allows us to more easily enter other jurisdictions and markets.
Our vision is to make our technology accessible to everyone. This is one of many steps in achieving our vision.
With two FDA clearances (Medo-Thyroid and Medo-Hip), and licensing from Health Canada in the works, we are constantly looking to improve and refine our technology.
We are currently looking to engage in partnerships with American Radiology Clinics and Centers of Health. If your organization’s goal is to bring a higher standard of care to your patient’s journey, please contact email@example.com.