iHealth Lab, a subsidiary of China-based Andon Health, just received 510(k) clearance from the FDA for a wrist-worn, Bluetooth-enabled blood pressure monitor called the iHealth BP7 Wireless Blood Pressure Wrist Monitor that will connect with iPhones, iPads, and iPod touch devices.
The original iOS-enabled iHealth blood pressure cuff, which the company launched at the Consumer Electronics Show at the beginning of 2011, took its measurement by wrapping around the user's upper arm like a traditional cuff. The original device also required the user to nest their iOS device in a dock that connected to the cuff via a cable. The new device adds Bluetooth connectivity. Like the original monitor the new one will also rely exclusively on the iOS device to display readings since it has no display screen of its own.
Andon explains in the FDA clearance document that the "Fully Automatic Wireless Blood Pressure Wrist Monitor is [intended] for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 13.5cm-22cm." Unlike the original device Andon released through its iHealth Lab brand last year, the new one will take its reading as the cuff inflates rather than while it deflates like the wired version did.
The regulatory documents show that Andon applied for its clearance in early May 2012 and received the FDA's decision a little more than a month later in mid-June.
This past month the FDA also cleared a handful of other connected devices and at least two apps. As we previously reported, the connected toothbrush Beam Brush and its companion smartphone app received a nod from the FDA. Gauss Surgical also received a Class 1 nod from the regulator for its iPad app called Pixel App. here's how the company described the device in its filing:
"The Gauss Pixel App is a software program used on an iPad tablet to capture images of sponges to assist surgical personnel in the management of surgical sponges after surgical use. The App, allows surgical personnel to categorize sponges by sponge type and provides an automated ongoing count of total sponge images and sponge images by tag. It also provides a visual record of images for further evaluation. This program is not intended to replace existing sponge counting practices and sponges should be retained per the user's standard sponge management practice until the case is complete and sponge counting has been finalized."
ShenZhen Healthcare Electronic also received 510(K) clearance for its WiFi Body Scale, which looks to compete with similar offerings from Withings and iHealth. ShenZhen has added support for its WiFi-enabled scale by launching apps for iOS devices, according to the regulatory filing. Here's how the company sums up the device's intended use:
"[The Wi-Fi Body Scale] is indicated to measure body weight, estimate body fat, body water percentage, body muscle mass, bones mass, visceral fat rating and daily calorie intake (DCI) using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults, who are not ill, feverish, have a chronic or acute disease, or a condition that affect the level of hydration such as pregnancy."