FDA clears Bluetooth BP monitor, 7-day wearable ECG, and two other digital health products

By Jonah Comstock
04:27 pm

Chinese medical supply company Shenzen-Kingyield has received FDA 510(k) clearance for a Bluetooth-connected blood pressure monitor. The device is worn on the wrist and sends data to a smartphone for archiving or analysis, according to the clearance document, and the device has been cleared for over the counter sales. The company makes a variety of blood pressure monitors, blood glucose monitors, infrared thermometers, pulse oximeters , and nebulizers that it sells to hospitals and other enterprise customers.

Cardiac Insight, a Kirkland, Washington-based company that makes a portable, Bluetooth-connected EKG device for athletes, received an FDA clearance for the Stealth System S300, a prescription-only continuous ECG recorder that can be worn for seven days. The device appears similar to (and in fact lists as a predicate device) iRhythm's ZIO patch. Like the ZIO patch -- and unlike Cardiac Insight's existing CardeaScreen device -- the Stealth System isn't wirelessly connected: the data has to be manually downloaded via a cable after the patient finishes wearing it. Nevertheless, both devices provide a significant improvement over Holter monitoring in terms of cost and ease of use.

Intuity Medical, the diabetes management technology company that closed a $55 million funding round in January, received clearance for a software update to its Pogo blood glucose monitor. Pogo received FDA clearance in April 2016, and consists of a test port, lancets and lancing device in one compact meter and cartridge system, which allows users to quickly perform a glucose test discreetly in public settings or when they are pressed for time. The recently cleared software update will allow users to add more blood to a test strip if the device fails to read it for any reason, rather than having to use a fresh strip and potentially waste a cartridge, the company told MobiHealthNews.

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Rochester, New York based medical imaging company CareStream received 510(k) clearance for SmartGrid, a new feature that will be added to its DirectView DR software. SmartGrid is an algorithm that cleans up certain kinds of noise on particular radiological images. The feature "is designed to improve contrast and reduce the appearance of scatter in radiographic images that have been acquired without a physical grid" according to clearance documents, which also explain that the clearance includes "an algorithm for estimating and removing scatter from radiographic images."


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