Health & Wellness

The Gluco Quantum® is a personal, portable, self-measuring, consumer device, able to monitor heart rate, blood pressure, blood oxygen saturation levels, ECG and blood glucose – noninvasively.

Preventive health is growing in popularity as people seek to improve their overall health and wellness by making better choices.

An important element in chronic illness conditions and disease prevention is more attention and awareness about your health status daily. Information from daily monitoring can help to detect any abnormalities and negative trends. When alerted, consumers can start making certain lifestyle choices.

The Best Investment

The best and most valuable investment you will ever make is in your health. A long-term commitment in how you manage your health can limit and minimize illnesses, diseases and chronic conditions that can provide high returns in your quality of life for you and your family.

Regular Health Checkups

Regular health assessments are key elements of health promotion and disease prevention. However, consumers only visit their doctor once a year or less which increases the risks of a health problem going undetected. Daily monitoring of the vital signs can help to detect early signs of a possible health problem.

Managing existing health conditions is also part of the preventive care process, as certain behaviors can reduce symptoms or better manage diseases altogether. With daily monitoring, consumers can take better control of their health to live better, more fulfilling lives.

Technology has brought many improvements to various aspects of our lives, not the least of which is our healthcare system. A good example is the use of software for easy tracking, saving, and retrieving information regarding various sicknesses and diseases.

Some of the conditions that have been tested so far using innovation include diabetes, circulatory system and heart disorders, and behavioral and mental health disorders.

How Are Digital Health Products Used?

Providers and other stakeholders are using digital health technologies in their efforts to:

  • Reduce inefficiencies,

  • Improve access,

  • Reduce costs,

  • Increase quality and make medicine more personalized for patients.

Patients and consumers can use digital health technologies to better manage and track their health and wellness related activities.

The use of technologies, such as smart phones, social networks, and internet applications, is not only changing the way we communicate, but also providing innovative ways for us to monitor our health and well-being and giving us greater access to information. Together, these advancements are leading to a convergence of people, information, technology, and connectivity to improve health care and health outcomes.

FDA Focuses on Digital Health

General Wellness: Policy for Low Risk Devices

The Food and Drug Administration (FDA) is issuing this guidance document to provide clarity to industry and FDA staff on the Center for Devices and Radiological Health's (CDRH's) compliance policy for low risk products that promote a healthy lifestyle (general wellness products).1 This guidance does not apply to products (e.g., drugs, biologics, dietary supplements, foods, or cosmetics) regulated by other FDA Centers or to combination products.2

Section 3060(a) of the 21st Century Cures Act (Cures Act) amended section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) on December 13, 2016, removing certain software functions, including those intended for maintaining or encouraging a healthy lifestyle that are unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition

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