MiyaHealth, a Singapore-headquartered global software as a service (SaaS) HealthTech, has announced that it has secured ISO 13845:2016 certification and a CE Mark for GensuApp, its chronic disease management platform created in partnership with Bioton S.A., a Poland-based biotech company.
In compliance with the European Union (EU) Medical Devices Regulatory Approval 2017/745, the CE Mark renders GensuApp as a Class 1 medical device, and allows MiyaHealth to place the product in Europe, MiyaHealth said in a statement on Tuesday.
Developed under MiyaHealth’s proprietary product suite MiyaPatient, GensuApp focuses on diabetes management for patients, and it will be rolled out in Poland in the coming year.
According to the statement, MiyaHealth plans to expand its MiyaPatient suite into potential markets of interest, and to onboard more partners, including insurers, hospitals, and government entities to develop tailored solutions that will scale up healthcare efficiency and access in these countries.
The company has successfully concluded their Pre-Series A fundraise in August this year and plans to raise Series A in 2024.
MiyaHealth said that attaining the CE Mark for its chronic disease management platform is a significant milestone for the firm as it demonstrates the company’s technological capabilities and commitment to meeting the highest quality and safety standards expected of the healthcare industry.
It is noted that MiyaHealth is also one of the first Asia-based HealthTech companies to place software as a medical device in Europe.
According to the statement, the CE Mark and ISO certification give MiyaHealth’s partners the confidence and assurance that its products meet the general safety and performance requirements (GSPR) of all relevant European medical device regulations, and are developed based on MiyaHealth’s established quality management system.
“As a company, we consider the CE mark and ISO certification a hallmark in our growth trajectory as it has only been slightly over a year since we launched MiyaPatient and we have already made huge leaps in expanding our offerings worldwide, starting with Europe,
According to the statement, GensuApp is developed under MiyaHealth’s proprietary product suite, MiyaPatient, a patient navigation platform that includes an AI-driven, predictive and personalized system MiyaAvatar to help them cope with their daily challenges.
It proactively guides patients in chronic disease monitoring, medication, and care education and navigation.
It is also compatible with a broad range of medical devices such as glucometers.
The development of the proprietary technology and its viability validation was supported by Enterprise Singapore.
MiyaHealth is also an investee of SEEDS Capital, its investment arm.
Recognizing these unmet needs, as well as the rising diabetes burden in Poland, MiyaHealth and Bioton S.A. partnered to develop GensuApp, a chronic disease management platform for diabetic patients.
It was launched as a pilot initiative in 2022, and will be officially rolled out to Polish users.
“Today’s technology, if adapted and used correctly can greatly assist patients, carers and doctors in living a better quality of life and to avoid severe adverse effects of their conditions,
“Bioton S.A. decided to develop GensuApp with MiyaHealth to enable access to rapidly processed data and AI technology,” said Jeremy Launders, Chief Executive Officer at Bioton S.A..
According to him, this partnership supports the course of the firm patient’s treatment and management of their conditions, ultimately leading to better outcomes.
He also noted that managing diabetes can be challenging due to the numerous tasks required to achieve optimal glycaemic control.
Thus, he said the firm has customized GensuApp with MiyaHealth to provide a comprehensive overview, offering patients and doctors real-time data to empower them to make better immediate decisions.
“Being the first of its kind in Poland, the GensuApp will allow us to support a wider network of people with diabetes,
“During our pilot programs, we have received excellent feedback from our patients,” he added.