Back at the beginning of May, we reported on several mobile health FDA clearances from the previous month. But the FDA has been even busier than that, clearing at least three other big name mobile products in April, and a few more already in May.
First off, this month a couple of different iPad apps received FDA clearance. At the American Telemedicine Association conference in Baltimore, telemedicine technology provider InTouch Health announced an app that would allow auscultation from digital stethoscopes in near-realtime. Auscultation means listening to the internal sounds of the body like heartbeat or digestion sounds. InTouch says that up until now digital stethoscopes have relied on store and forward technology, but InTouch's CS App transmits live from a patient to a doctor at a remote location.
Meanwhile, Gauss Surgical announced that it has received de novo FDA clearance for an app that uses the iPad's camera to estimate the amount of blood lost during a surgery and captured with surgical sponges. The system is called the Triton Fluid Management System.
"Using the iPad camera, the system scans surgical sponges that are covered in blood, and sends the images to the cloud where image-processing algorithms estimate the amount of blood contained on that surface and sends it back to the OR in real-time," the company said in a statement. "Triton features an intuitive iPad interface, requires minimal training, and seamlessly integrates into existing surgical workflow. The system is fully HIPAA compliant."
CloudEKG, from TeleEMG appears to be the latest smartphone-connected EKG device. The 12-lead device's clearance document says it uses Bluetooth to connect to a PC or handheld device. The stated use case is outpatient and home monitoring, and the device is cleared for prescription use.
Entra Health Systems, one of the earliest entrants into the smartphone-connected glucometer space, has received clearance for the MyHealthPoint telemedicine manager, an online and mobile software offering that would collect and store biometric data from a variety of sources. It measures vitals including glucose, blood pressure, weight, body composition, activity, body temperature, ECG, and pulse oximetry.
"MyHealthPoint TeleHealth Manager is intended to be used by patients in non-clinical settings (e.g. home) to collect, record and transmit their biometric data to a remote secure server," the FDA clearance document reads. "Stored data is accessible by healthcare professionals and caregivers for analysis, messaging and intervention using standard digital communication technologies and protocols. Patients may also view the data to assist in self-management of their specific health condition." It is cleared for both prescription and over the counter use. Correction: A previous version of this story referred to MyHealthPoint as a smartphone app.
Finally, Carestream, which got clearance for its VUE Motion mobile radiology imaging software back in February, has received an additional clearance for its Carestream Image Suite Tablet Viewer, an HTML 5 app intended for viewing and interpreting radiological images on the go.