FDA approves U of A spinoff company MEDO’s tool offering simpler, more reliable diagnostic scans for thousands of patients.
May 28, 2021 By Keri Sweetman
A University of Alberta spinoff company has received FDA approval for an artificial intelligence tool that could revolutionize thyroid ultrasounds, making the procedure faster and easier for thousands of Canadians who undergo it each year.
MEDO.ai, with offices in Edmonton and Singapore, received approval last month from the U.S. Food and Drug Administration for its thyroid ultrasound technology.
“This is our crucial first approval. We will be seeking additional approvals in Europe, Canada and worldwide,” said MEDO co-founder Jacob Jaremko, associate professor in the Department of Radiology and Diagnostic Imaging, who started the company in 2018 along with Dornoosh Zonoobi, a former post-doctoral fellow at the U of A and research fellow with Alberta Innovates, and Jeevesh Kapur, a radiologist from Singapore.
The MEDO-Thyroid tool, the first of its kind in the world, starts with an ultrasound video sweep of the thyroid gland, then uses AI software to analyze the results of the scan. The company describes the process as “seamless, fast and objective.”
Faster, easier process for patients and clinicians
One ultrasound scan is performed for every three Canadians each year, of which three to five per cent are thyroid ultrasounds. Women receive more thyroid ultrasounds than men because they are more likely to have lumps or nodules on the thyroid gland in the neck. Although these nodules are usually benign, they can be malignant, so patients require regular followup ultrasounds. An estimated 8,600 Canadians were diagnosed with thyroid cancer in 2020.
The current approach is for a sonographer to slide an ultrasound probe from top to bottom and side to side on the neck, taking multiple side-view and transverse-view pictures of the bowtie-shaped thyroid gland, while locating, measuring and characterizing any nodules. The process is time-consuming and the next step—interpretation by the radiologist—is complicated and potentially error-prone.
Jaremko said inconsistency in describing nodules and interpreting ultrasound results can lead to confusion and false negatives or positives. False positives can result in unnecessary biopsies, the next step in determining whether a suspicious nodule might be malignant. False negatives could mean a malignancy isn’t discovered.
“It’s very frustrating because most of the nodules are benign, but occasionally there is a needle-in-a-haystack one that’s malignant,” said Jaremko, who holds the Alberta Health Services Endowed Chair in Diagnostic Imaging at the U of A and is a member of the Women and Children’s Health Research Institute.
MEDO’s software analyzes the videos taken by a sonographer, locating, measuring and characterizing any significant nodules and selecting optimal images for analysis. The system produces a preliminary report, giving a score for each nodule indicating whether it is likely benign or malignant. The radiologist is free to edit the report if they have a different opinion on the findings.
“This will make scanning thyroids much simpler and more reliable, especially in people with complex thyroid glands who need followup,” said Jaremko. “We are avoiding confusion, making things simpler, faster and easier for patients and clinicians.”
Pilot testing in Edmonton area
MEDO is doing an investigational trial of its thyroid ultrasound tool at a Sherwood Park clinic run by MIC Medical Imaging, scanning several patients a day using the software, as well as using conventional ultrasound as a backup. The pilot will continue until the end of June, then Jaremko and his team will analyze the results. If they are comfortable with the findings, they hope to be using the software in all 10 MIC clinics in the Edmonton area by the end of the year.
The company will then begin marketing the system to other radiology groups, starting in Western Canada, as well as busy endocrinology clinics that could use the tool to do their own scans. The Singapore arm of the company hopes to piggyback on the FDA approval to get the go-ahead to roll out the tool there soon. Marketing will also begin in the U.S. and eventually in Europe once approvals are obtained there.
This is not MEDO’s only AI-based ultrasound tool. They have four, three of which have been approved by the FDA, including MEDO Hip, a tool to screen newborn babies for hip dysplasia, a common hip joint problem that leads to osteoarthritis but is easily fixed if detected early.
“We realized that the three of us shared the same vision of democratizing medical imaging through simplifying the use of ultrasound,” said Zonoobi, who was the mastermind behind the startup and is now CEO.
The new tool is already being used by specially trained nurses in two clinics in the Westview Primary Care Network in Spruce Grove. Jaremko expects it will soon be used in other primary care clinics in the Edmonton area, and hopes it will then move into clinical practices throughout Alberta.
The company is also developing other applications, including lung and fracture ultrasounds, and has recently done several trials scanning patients with COVID-related pneumonia in ICUs.
MEDO has 25 employees working out of the U of A Health Hub & Accelerator space in Enterprise Square in downtown Edmonton, but Jaremko says that number could easily grow to 100 over the next few years, making the company one of the high-tech engines for economic diversification in Alberta. Many new hires are graduates of the U of A’s Department of Computing Science.
Zonoobi noted that the mentorship support the company has received through the Health Hub has been useful for connecting the company with resources and even talent.
“We felt connected to the entrepreneurial community and plugged into the university infrastructure at the same time.”
Jacob Jaremko’s U of A research is supported by a number of partner organizations, including the Stollery Children’s Hospital Foundation through the Women and Children’s Health Research Institute, MIC Medical Imaging and Alberta Innovates.
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