FAQ
ELIXIR utilizes advanced near-infrared (NIR) spectroscopy to perform non-invasive blood analysis. By emitting NIR light, the device captures data on how the light is absorbed, reflected, and scattered by blood vessels.
These measurements are then analyzed using proprietary algorithms. Our spectroscopic technology and algorithms undergo continuous enhancements to ensure greater accuracy.
Currently ELIXIR only provides blood sugar level.
However, after its official release, ELIXIR is expected to be supported with at least two additional biomarkers on annual basis.
ELIXIR currently provides an accuracy of approximately 85%, MARD 15%.
We are actively engaged in ongoing research and development, aiming to achieve MARD 8.2% of less.
Yes, ELIXIR is beneficial to everyone. Blood reflects overall physical health and acts as a crucial indicator for disease prevention and diagnosis.
With ELIXIR, you can conveniently monitor key health indicators, including symptom screening, health assessments, treatment progress, and nutrition status.
Stay proactive with ELIXIR — because the best time to manage and protect your health is when you are healthy!
The ELIXIR will be available for purchase soon.
To stay informed about its release and pricing, we invite you to join our email list.
Subscribers will be the first to know about any updates.
No, ELIXIR is a healthcare device, not a medical device.
ELIXIR primarily aims to be beneficial for monitoring and supporting the prevention of serious illnesses.
Within diabetes patients, it is most suitable for individuals managing prediabetes or Type 2 diabetes.
Type 1 diabetes patients should consult with their healthcare providers for proper treatment.
The Elixir device is integrated with the Elixir APP, where users can easily view their analytics through their mobile phone or tablet.
ELIXIR is not currently covered by insurance.
However, we are actively working on exploring potential coverage options and will keep our customers informed of any updates.
Elixir is a battery-powered portable device used to measure blood glucose levels non-invasively and without pain.
When the user places the Elixir device on the palm of their hand, Elixir utilizes cutting-edge technology to analyze the blood glucose level of the user.
It transfers the data onto the Elixir APP, where the user can view test analytics.
ELIXIR stands out from other similar products through its advanced near-infrared (NIR) spectroscopy technology, which enables non-invasive and painless health monitoring.
Unlike traditional devices that may require blood samples or invasive procedures, ELIXIR analyzes blood components through light absorption, reflection, and scattering.
Additionally, ELIXIR's proprietary algorithms provide real-time insights into your health, supporting early detection and prevention of potential issues. Its user-friendly design, continuous accuracy improvements, and commitment to making proactive health management accessible further set it apart.
No, ELIXIR is NOT a medical device and cannot provide a medical diagnosis.
It is designed as a healthcare device to monitor and assess key health indicators.
While it can offer valuable insights into your overall health, it should not be used as a substitute for professional medical advice or diagnosis.
For any medical concerns, we recommend consulting with a healthcare professional.
Yes, ELIXIR is designed to be user-friendly and accessible, even for individuals without medical knowledge.
Its intuitive interface and clear instructions make it easy to monitor your health indicators.
Yes, ELIXIR is safe to use.
It utilizes a non-invasive near-infrared (NIR) light source, which simply emits light to analyze blood components.
Since no needles are used, the process is painless and free from known side effects.
Yes, the B2B version of Elixir has received FDA Class I registration as a general healthcare device.
In compliance with FDA regulations, any significant hardware or software changes—including enhancements for consumer (B2C) use—require a new submission and re-evaluation.
BIOPOP has already submitted the upgraded B2C version of Elixir for FDA clearance and is currently undergoing the standard review process.
Reference: FDA guidelines require updated registration or premarket notification (510(k)) when a device is modified in a way that could significantly affect its safety or effectiveness. (FDA 21 CFR § 807.81)