Withings announced that the FDA has provided its iOS-powered blood pressure monitor with 510(k) clearance, and the company wasted little time making the device commercially available in the US. The FDA filed 510(k) clearance for the device about one month ago -- on May 20, 2011 and the device went on sale over the weekend.
According to the FDA's 510(k) clearance notice, the device is intended to be used in this way: "The Withings Blood Pressure Monitor, Upper Arm Type: BP-800 is [a] noninvasive blood pressure measurement [system] intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to be 9'-17' (22cm-42cm) for Upper Arm type."
First announced at Consumer Electronics Show (CES) this year, the monitor, which retails for $129.99, runs on three AAA batteries and works in conjuction with a iPhone, iPad or iPod Touch. Users start their testing by using a free iOS app, which they are prompted to download immediately after plugging the device in. Results of the test are delivered about thirty seconds later, and alert users to unhealthy BP ranges. These results, including date and time for tracking purposes, can then be e-mailed to a physician via the app or instantly synced to health monitoring services like Microsoft HealthVault and Google Health. If the user owns a Withings body scale, that data will also be included in their results graph.
Also announced at CES was iHealth's blood pressure cuff, which also connects to iOS devices but makes use of a cradle instead of just the standard dock connector cord that Withings' device uses. iHealth's device secured FDA clearance in early February, just weeks after the CES event and is now for sale at Apple Stores for under $100. The FDA 510(k) clearance letter for the iHealth device provided indications for use that were in effect identical for the Withings device.
Check out the full press release after the jump.
Paris, France – June 20, 2011– Today, French technology company Withings announced the US availability of its Blood Pressure Monitor (BPM) for iPad®, iPhone® and iPod touch®. This Withings BPM, including blood pressure cuff and companion Withings App, is a modern way to measure and record blood pressure readings in the personal and professional arenas.
With more than 25% of the world’s population* affected by hypertension, Withings has combined advanced technology and sophisticated design to create a medical device that is visually attractive, accurate and easy to use at home, in a professional setting or on the go.
Cédric Hutchings, Withings co-founder says, “Apple has revolutionized the smartphone and tablet market with both its design and functionality. We have strived to extend this revolution into the field of health and fitness by integrating our products to work seamlessly with Apple iOS devices.”
The Withings BPM is truly a plug-and-play solution for blood pressure measurement and tracking. Users simply wrap the blood pressure cuff around their arm and plug it directly into their iPad, iPhone or iPod touch using the incorporated cable. Once connected, the Withings App launches instantly on the iOS device and is ready to begin the measurement. When the reading is complete, the full results (Systole, Diastole and heart rate) are saved directly on the device, eliminating manual tracking.
A user’s stats can be accessed instantly from their iOS device or from their personal Withings webpage. Results are saved denoting dates and time of day for each reading, to help when comparing morning, afternoon and evening readings, and readings over time. Results can easily be shared by emailing results to a doctor and/or using the device’s automatic sharing feature to sync with popular personal health record sites like Google Health™ and Microsoft® HealthVault™ - virtually eliminating the gap between patient and doctor.
When used in conjunction with the Withings WiFi body scale, weight and blood pressure are tracked on the same graph within the app, giving users an at-a-glance health snapshot. Both products bring together in one place two vital pieces of your overall health, which is ideal when tracking trends and early warning signs of health problems.
Withings Blood Pressure Monitor Technical Specifications: (detailed specs)
•Works with: iPad, iPad 2, iPhone, iPhone 3G, iPhone 3GS, iPhone 4, iPod touch 2nd generation, iPod touch 3rd generation and iPod touch 4th generation
•Measurement: Oscillometric Method
•Measurement range: 0 to 285mmHg
•Pulse: from 40 to 180 beats per minute
•Cuff circumference: fits arm circumferences from 9” to 17”
•Pump: automatic inflation with air pump, controlled pressure release
•FDA: device has received FDA clearance
The Withings Blood Pressure monitor works with iPad, iPhone and iPod touch. Starting today, the Withings Blood Pressure Monitor is available at www.withings.com for $129. The Withings App is available for free from the App Store on iPad, iPhone and iPod touch, or at www.iTunes.com/AppStore.
For more information on Withings, go to www.withings.com/press. To request additional information or images of the Blood Pressure Monitor or WiFi Body Scale, please contact PR representative Jessica Darrican at (305) 576-1171 ext.16 or jessica@maxborgesagency.com.
* “Global burden of hypertension: analysis of worldwide data” / Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans
http://www.ncbi.nlm.nih.gov/pubmed/15652604
About Withings:
Withings designs, develops, and industrializes connected objects. As French start-up established by three executives from technology and telecom industry, Withings has a focus on innovation and design for everyday products. In September 2009, Withings release the world’s first internet and WiFi connected body scale. Withings is an actor in the Internet of Things and thus increases capabilities of an object by network resources allows accessing to infinite calculation and storage capacities without increasing the cost. The object’s interfaces are also ported to devices like mobile phones or computers, to benefit from their resources. Withings makes internet connected objects. www.withings.com
