Profusa, a company based in South San Francisco, CA, won European CE Mark approval for its Lumee Oxygen Platform. The tissue oxygen sensing system consists of a tiny hydrogel sensor implant that comes with its own injector, a reader that captures what the sensor is measuring, and a touchscreen interface.
The implant, no more than 5mm in length, has fluorescent molecules attached to its body. When oxygen is nearby the molecules becomes exposed, and shining a light of specific wavelength onto it makes it glow. The more oxygen, the more of these molecules are exposed and the fluorescent signal is brighter.
The optical reader is placed against the skin above where the implant is. It emits light and detects a returning signal, thereby measuring oxygen concentration. It can either be used for spot checking oxygenation or by sticking it to the skin it can provide continuous readings throughout the day and night.
Initially the technology will be used to assess tissue oxygen saturation in people with peripheral artery disease (PAD), and more applications are slated for the near future. In the meantime the Lumee system will have to prove itself in an international multi-center study before getting the FDA green light to make it available in the U.S.
Here’s a Profusa video introducing the Lumee Oxygen Platform:
Product page: Lumee…