Rumor: Is Apple’s iWatch Stuck in FDA Limbo?

Source: Thinkstock

Source: Thinkstock

With the expected launch date for Apple’s (NASDAQ:AAPL) fabled iWatch a little over three months away, the perpetual tech industry rumor mill appears to have moved into high gear. The most recent rumor comes courtesy of Chinese news site Laoyaoba via GforGames. According to “Apple insiders” cited by Laoyaoba, the technical specifications and design of the iWatch have already been finalized, but the production of the device is on hold while the company waits for approval from the Food and Drug Administration. This indicates that the iWatch is being certified as a diagnostic medical device, rather than a purely educational or informational product.

An FDA memo recently obtained by Apple Toolbox provided an overview of the discussions that took place between Apple and FDA officials in a meeting last year. Much of the conversation described in the memo revolved around what would qualify a health-monitoring mobile device for regulation by the FDA, including a long discussion about a hypothetical mobile device that monitored blood glucose. Tellingly, Laoyaoba’s sources reported that the iWatch would include biometric sensors to monitor heart rate, blood pressure, and blood glucose. The sources also reported that Apple had developed its own proprietary sweat analysis sensor for the iWatch.

While getting FDA certification adds another hurdle that Apple must clear before it can release the iWatch, the decision to design the device as a medical diagnostic tool will likely give the iWatch a competitive edge over other wearable tech devices on the market that only offer health metrics without the weight of an FDA certification behind them. It also aligns with the company’s decision to develop its HealthKit data storage platform with the cooperation of the Mayo Clinic. As a certified medical device, the information collected by Apple’s iWatch will be qualified to be integrated with other health record information at participating health institutions.

It should be noted that some of the iWatch details reported by Laoyaoba’s sources contradicted information reported by other media outlets’ sources this week. On Friday, unnamed sources cited by The Wall Street Journal reported that Apple is planning on releasing multiple versions of the iWatch with different screen sizes, including at least one model that will be packed with over ten types of health-monitoring and fitness-tracking sensors. However, Laoyaoba’s sources only mentioned one model of iWatch.

The Wall Street Journal’s report came on the heels of another report from Reuters on Thursday that indicated that the iWatch would feature a slightly rectangular 2.5-inch screen. Both media outlets’ sources reported that Taiwan’s Quanta Computer would manufacture the device. However, while The Wall Street Journal’s sources reported that mass production would likely begin in several months following a trial run in July; Reuters’ sources reported that full mass production would kick off next month. The Wall Street Journal’s sources also suggested that the specifications for the iWatch had not yet been finalized.

Although there are multiple health-related wearable tech devices already on the market, none that have been released so far have ignited much consumer excitement. Apple arch-rival Samsung (SSNLF.PK) released the fitness-tracking Gear Fit device in April of this year, but the device has not been widely adopted and several tech reviewers — including one at CNET — were critical of the Gear Fit’s narrow display and limited capabilities.

Christian Lindholm — CEO of Finnish wearable tech company Koru — is one industry watcher who believes that the wearable tech market is ripe for Apple’s entry. “Consumer electronics companies led by Samsung build market awareness,” noted Lindholm in a wearable tech-themed presentation last December. “Wearables get transformed through curved displays. Apple enters with a big bang.” Assuming that all goes well at the FDA, most sources believe that Apple’s “big bang” will happen in October.

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