Sam Brusco, Associate Editor04.30.24
Toku, a medical device company specializing in imaging tech and artificial intelligence (AI), has earned Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its MyKidneyAI technology.
MyKidneyAI leverages AI to analyze retinal images from routine eye exams to spot elevated chronic kidney disease (CKD) risk in people with diabetes. Most people with diabetes aren’t routinely screened for CKD, which causes the disease to not be detected until it’s developed to an advanced stage where straightforward interventions aren’t effective any longer.
The retina is the only part of the vascular system that can be easily photographed to spot microvascular disease, a contributor to CKD. MyKidneyAI was built to help identify people with diabetes who have higher CKD risk with a simple eye exam in eye care or primary care settings.
Toku said it’s working closely with strategic investors, as well as Topcon Healthcare (provider of eye care medical devices and software solutions) and National Vision (a large U.S. optical retailer) to offer MyKidneyAI in the U.S.
"Given the potential impact of this technology for people with CKD, we are extremely proud to have advanced MyKidneyAI so quickly,” said Ehsan Vaghefi, Toku’s CEO. “We have now achieved two FDA Breakthrough designations in under a year, which is particularly impressive because we are one of only a handful of startup companies to do so in the FDA Breakthrough Devices program’s history. This is a testament to our team's innovative approach and commitment to making a significant impact in healthcare.”
Toku won its first FDA breakthrough nod for its CLAiR cardiovascular risk identification product six months ago. CLAiR gained EU and UKCA approval for AI-enabled cardiovascular risk assessments earlier this month.
Patients with impaired kidney function experience much higher rates of death and cardiovascular events. CKD is generally asymptomatic until it reaches an advanced stage, requiring dialysis or kidney transplantation. Diabetes is the leading cause of kidney disease in developed and developing countries. About 40% of people with diabetes have CKD, but screening is not routinely performed.
Managing patients with CKD costs Medicare over $130 billion each year, with $35 billion (over 7% of total Medicare spending) going to care for the 0.1% of the population suffering from kidney failure. Earlier identification of patients with CKD is key to enabling both clinical and economic improvement.
MyKidneyAI leverages AI to analyze retinal images from routine eye exams to spot elevated chronic kidney disease (CKD) risk in people with diabetes. Most people with diabetes aren’t routinely screened for CKD, which causes the disease to not be detected until it’s developed to an advanced stage where straightforward interventions aren’t effective any longer.
The retina is the only part of the vascular system that can be easily photographed to spot microvascular disease, a contributor to CKD. MyKidneyAI was built to help identify people with diabetes who have higher CKD risk with a simple eye exam in eye care or primary care settings.
Toku said it’s working closely with strategic investors, as well as Topcon Healthcare (provider of eye care medical devices and software solutions) and National Vision (a large U.S. optical retailer) to offer MyKidneyAI in the U.S.
"Given the potential impact of this technology for people with CKD, we are extremely proud to have advanced MyKidneyAI so quickly,” said Ehsan Vaghefi, Toku’s CEO. “We have now achieved two FDA Breakthrough designations in under a year, which is particularly impressive because we are one of only a handful of startup companies to do so in the FDA Breakthrough Devices program’s history. This is a testament to our team's innovative approach and commitment to making a significant impact in healthcare.”
Toku won its first FDA breakthrough nod for its CLAiR cardiovascular risk identification product six months ago. CLAiR gained EU and UKCA approval for AI-enabled cardiovascular risk assessments earlier this month.
More about chronic kidney disease (CKD)
CKD is a general term used to describe disorders affecting kidney structure and function. According to the National Kidney Foundation, CKD affects about 15% of the U.S. population, but nine out of 10 people with CKD are unaware they have the condition.Patients with impaired kidney function experience much higher rates of death and cardiovascular events. CKD is generally asymptomatic until it reaches an advanced stage, requiring dialysis or kidney transplantation. Diabetes is the leading cause of kidney disease in developed and developing countries. About 40% of people with diabetes have CKD, but screening is not routinely performed.
Managing patients with CKD costs Medicare over $130 billion each year, with $35 billion (over 7% of total Medicare spending) going to care for the 0.1% of the population suffering from kidney failure. Earlier identification of patients with CKD is key to enabling both clinical and economic improvement.