Masimo iSpO2 Turns iPhone into Oximeter That’s Not a Medical Device

Masimo, a medical devices company, showed off a new iPhone-compatible oximeter that can help you track of users’ cardiovascular health at CES 2013 in Las Vegas. The Masimo iSpO₂ is not a true medical device, but it is an example of how the iPhone and iPad can be transformed into more than ‘just’ communications and entertainment devices.

The Masimo iSpO₂ slips over the user’s finger. A cable runs to the iPhone and connects via a 30-pin connector. A red laser beam and a sensor in the finger collar senses the user’s oxygen saturation and pulse rate. A 30-pin to Lightning port adapter can be used for those with the iPhone 5 or latest iPads.

The device costs $249, which is pretty expensive compared to most iPhone and iPad devices, but cheap compared to a hospital- grade oximeter. Of course you can pick up a non-iPhone compatible oximeter for about $50 at your local drugstore.

The device includes a free app that keeps track of a user’s oxygen saturation and pulse rate history. The company says that this is useful for athletes that are training or performing athletic feats such as scaling high mountain peaks. Unfortunately, the app can only keep track of one user’s history. It would be more useful if it could track multiple athletes so power users, such as coaches and personal trainers, could use the app to track multiple athletes or clients.

It is important to note that the device is not a medical product and has not cleared the FDA. As such, the company is not able to market the device as a health device, but rather a sports-related accessory. The device’s box notes that this is a non-medical device, but there will likely be consumer confusion since people with health conditions, such as asthma, are the most likely to buy oximeters.

During the demonstration, the Masimo iSpO₂ reported lower readings than what we’ve seen with all the devices. For example the oximeter reported a 95% Oxygen saturation during our demonstration, which is far below normal, though nobody was short of breath or wheezing. Asthma patients will have a tough time getting discharged from a hospital with a reading in the low 90’s. According to the manufacturers specifications, the oximeter is accurate to plus or minus 2%, which means there’s a 5% spread. That’s far too large since the difference between perfect (100%) and going to the emergency room is only 10%.