Nightingale Health receives regulatory approval for healthcare use from Health Sciences Authority in Singapore
Press release, 23 February 2024 at 9:00 a.m. (EET)
Nightingale Health, a pioneer in health risk detection and preventative health, has received regulatory approval from Singapore’s Health Sciences Authority (HSA), the national body that regulates medical devices, therapeutics, and other healthcare products. This first approval covers the analysis of eight common clinically used biomarkers: total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, apolipoprotein A1, apolipoprotein B, glucose, and creatinine.
Nightingale Health announced in November 2023 a collaboration agreement with Innoquest Diagnostics, a leading clinical diagnostics service provider in Singapore, to enable access to Nightingale Health’s blood analysis technology in Southeast Asia. The regulatory approval is an important step towards launching Nightingale Health’s comprehensive and high-quality blood testing services.
The approval is based on the review of conformity with the safety and performance requirements set for medical devices. The HSA approval means that Nightingale Health’s product satisfies the strict requirements for quality, safety, and efficacy.
Being able to comply with some of the world’s strictest regulatory requirements in healthcare demonstrates the applicability of Nightingale Health’s technology in routine blood testing, as it matches the quality of gold standard tests.
Moreover, in contrast to the current solutions, Nightingale Health’s technology enhances standard blood testing by offering a comprehensive panel of familiar gold standard biomarkers and, importantly, market-leading risk assessments for multiple chronic diseases from every measured sample. This capability empowers the building of more preventative and sustainable health systems worldwide.
“We are pleased to announce our first regulatory approval in Singapore and look forward to launching our blood analysis technology in collaboration with Innoquest Diagnostics and Pathology Asia. Routine blood testing in primary care has the potential to offer groundbreaking value in building more preventative and sustainable health systems. Nightingale Health’s technology realizes this by utilizing just a single blood sample. Our technology maintains the clinical use cases based on gold standard biomarkers but introduces at the same time a capability to assess also risks for multiple common chronic diseases,” says Teemu Suna, Nightingale Health’s CEO and Founder.
“Our technology can transform the efficiency of health systems by allowing the well-proven guideline preventative interventions to be applied at a scale and precision that has not been possible before. Our technology is already used nationwide in Finland for 30% of the working population's health checkups. We're working towards expanding our technology's use in healthcare internationally, and the first regulatory approval in Singapore shows the high quality and performance of our unique technology,” continues Suna.
For further information, please contact:
Teemu Suna, CEO
ir@nightingalehealth.com
About Nightingale Health
Nightingale Health is The Preventative Health Company. Staying healthy is one of the top priorities in human life. Our health has a profound impact on our quality of life, and it’s also strongly connected to the lives of those close to us. Nightingale Health enables prevention by combining the power of our in-house developed, advanced blood analysis technology with unprecedented access to global health repositories and world-leading medical research. With this combination, we go beyond the traditional healthcare and wellbeing tools: We provide the scientific connection to multiple health and disease outcomes and the ability to predict future healthy years.
Nightingale Health operates globally with a parent company in Finland and seven subsidiaries in countries such as Japan, the United States, Singapore, and the United Kingdom. Nightingale Health has customers in more than 34 countries in the healthcare and medical research sectors. The company’s technology is being used in many of the world’s leading health initiatives, such as the UK Biobank, and over 530 peer-reviewed publications validate the technology. The company’s Series B shares are listed on the First North Growth Market Finland marketplace. Read more: https://nightingalehealth.com
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