Unless you're a devoted reader of the Federal Register, you may have missed the Food & Drug Administration's recent guidance about what the agency really cares about when it comes wearable technology. The guidance, titled “General Wellness: Policy for Low Risk Devices,” is meant not only for the wearables industry, but for FDA staff in the Center for Devices and … [Read more...]
Could the GoBe Actually Work as Advertised?
The story of the Healbe GoBe is not a pretty one. The company crowdraised $1.1 million for the wristworn calorie counter and has blown multiple delivery dates while fighting back allegations that its central claim -- to measure caloric intake -- is nonsense. The BBC more or less cornered the company's CEO at CES last week and challenged him to a demo once and for … [Read more...]
New Bluetooth Version 4.2 Published; Allows Faster Speeds, Direct Connections to Internet
The Bluetooth SIG has published the specs for version 4.2 of the widely used Bluetooth standard, and the news is actually more exciting than it sounds. The latest spec promises data speeds about 2.5 times faster than the current version, and will allow devices to connect directly to IPv6 networks, instead of using phones or other devices as an intermediary. This means, for … [Read more...]
FDA Publishes Health Device Security Guidelines; Public Workshop Set
As wearables move further into the realm of bona fide health devices (see our site Health Tech Insider for lots more on the subject), developers and manufacturers will inevitably have to deal with the U.S. Food and Drug Administration. The FDA regulates health devices. Most current wearables don't fall under its jurisdiction, but it's entirely possible that more sophisticated … [Read more...]
Is This The Granddaddy of All Wearables Patents?
An email just landed in our inbox about US Patent 8,823,512, issued yesterday to one Donald Spector. Mr. Spector has a long list of inventions to his credit. But this one claims a patent for, well, read the abstract: A system and method for monitoring the state of an individual, in which a biological sensor is attached to the individual, and a wireless transmitter is attached … [Read more...]
Researchers Use Mid-Infrared Laser to Measure Blood Glucose Levels
This isn't so much about a current wearable product, but we're betting it's a technology you'll be seeing pretty soon. Researchers at Princeton University have developed a new approach that uses mid-infrared light to measure blood glucose levels without the need for a blood stick. Wearables that monitor heart rate typically use LEDs that transmit near-infrared light, with a … [Read more...]
U.S. Senator Calls for Better Privacy Protections for Wearables
In the United States, medical devices have strong privacy protections written into law. But fitness trackers are, pretty much by design, not medical devices. Therefore, U.S. Senator Chuck Schumer pointed out yesterday, it's possible that fitness data can be licensed to third parties without the customer knowing it. Schumer (D-NY) yesterday called on the Federal Trade Commission … [Read more...]
Samsung Files Wristwear Patents
A patent application is not a product (let alone a patent), but it's worth noting that Samsung's been revealed to have filed a few applications about wristwear interfaces. The filings, uncovered and collected by SammyToday and better explained by 9to5Google, seem to cover a lot of UI ground: the appearance of screens and interesting ways of interacting with the device using … [Read more...]
Wireless Charging for Implantable Tech
Contactless power charging is something that lots of tech types are working on; the benefits of being able to recharge a device without plugging it in are obvious. But for medical implantables, the challenges are greater. For one thing, the device that requires power may be some distance from a reasonable power source. Stanford University has produced research that promises … [Read more...]
Apple Hires Exec With FDA Approval Background
A couple of months ago, you may remember, Apple apparently sat down with officials of the U.S. Food and Drug Administration to talk about ... well, no one really knows what, but the widespread guess is that it had something to do with the much-rumored iWatch. Now, there's word that Apple has hired Divya Nag, an up-and-comer in the medical device world who has significant … [Read more...]