Ensho Health today announced that it has been issued a Medical Device Establishment License ("MDEL") from Health Canada authorizing it to manufacture and sell Class I medical devices in Canada (License Number 16208).
"This is an important milestone in our journey to produce safe, reliable and effective medical device software that improve early detection and personalized treatment of rare and complex diseases" said Kaveh Katebian, Ensho Health Chief Executive Officer.
Rare diseases are estimated to affect as many as 400 million people worldwide and can cause chronic illness, disability, and premature death. Screening and diagnosis have often relied on heuristic approaches informed by the personal experiences of individual providers and case reports in peer-reviewed publications. Patients with rare diseases often experience years-long diagnostic odysseys and delays in treatment as a result.
"Securing this MDEL allows us to execute on our vision of building the first data lab that makes computing algorithms for rare disease screening accessible to physicians" said Dr. Taha Bandukwala, Ensho Health Chief Medical Officer. Ensho will immediately begin developing medical device software that allow physicians to screen electronic health records with existing and novel algorithms. These software include proprietary machine learning algorithms trained on real world data. Ensho's pipeline of algorithms currently undergoing research and development include rare cardiovascular, neurological and rheumatic disorders that are difficult to screen for or lack definitive biomarkers, including transthyretin amyloid cardiomyopathy, Fabry disease, amyotrophic lateral sclerosis and adult-onset Still's disease.
About Ensho Health
Ensho Health is a health technology company that empowers physicians to do more with data. It provides software-enabled services for clinical research, quality improvement and accredited learning. Healthcare providers use its systems and services to match patients with clinical trials, enrol data in registry studies, assess guideline adherence rates, improve quality of programs and participate in self-reflective exercises including those accredited by oversight bodies.
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