|Masimo has launched the iSpO2, an iPhone-compatible pulse oximeter--courtesy of Masimo|
Masimo ($MASI) has unveiled its iSpO2 Pulse Oximeter, a noninvasive, iPhone-compatible device that allows patients to monitor their blood oxygenation and perfusion measurements on the go.
The direct-to-consumer device sells for $249 a pop and clips onto a user's finger, taking readings without breaking the skin and transmitting the data to an attached iPhone, iPad or iPod Touch. The device is not meant for medical use, but Masimo says it has filed for a CE mark and 510(k) clearance for a professional version of the tech.
"Masimo was founded on a mission to take noninvasive monitoring to new sites and applications," CEO Joe Kiani said in a statement. "The iSpO2 … represents our first consumer product and should create myriad new possibilities with the goal of further empowering people."
The tech joins a growing list of iPhone-compatible medical devices, both consumer-targeted and physician-directed, making their way onto the market of late. Earlier this month, AliveCor snagged 510(k) approval for a mobile heart monitor that snaps onto an iPhone and takes ECG readings, and Welch Allyn is seeking FDA clearance for its iExaminer, an ophthalmoscope that interacts with Apple's device and allows physicians to save and send images gathered in eye exams.
While devicemakers rush to integrate their treatment and diagnostics products with the popular phone, there remains something of an FDA gray area for vetting them. Physical products such as AliveCor's heart monitor and Masimo's oximeter can be approved the old-fashioned way, but what of diagnostic and therapeutic apps, which, in FDA terms, must go through the device process?
App developers such as MobiSante, which markets a smartphone-based ultrasound system, and WellDoc, maker of a diabetes management app, have applied for and received 510(k) clearances. Meanwhile, Akili Interactive Labs is blazing a trail all its own with Project Evolution, an app-based video game designed to treat ADHD, training players to concentrate without the use of drugs such as Adderall or Ritalin. The company is planning to file with the FDA once it's done with development.
- read Masimo's announcement