This past month the FDA cleared two mobile medical apps and one digital health platform as 510(k) Class II medical devices.
McKesson, one of the most vocal health IT companies lobbying for changes to how the FDA regulates medical software, secured clearance for a mobile medical app called McKesson Cardiology ECG Mobile. The web-based version of McKesson Cardiology ECG has been around for a few years and it enables clinicians to analyze and review ECG waveforms captured by a variety of vendors' ECG devices. According to the company, the web-based system offers "an end-to-end solution for 12- or 15-lead rest, stress and holter ECGs. These ECGs are received from a multi-vendor list of carts, patient bedside monitors, stress machines and holter analysis stations. The system is designed to reduce the nonproductive time in your day by providing anytime, anywhere access to ECGs (and other cardiac information) for review and reporting. Smart workflow tools streamline the administration and clinical over-reading of ECGs while automatically distributing results across the enterprise." Mobile versions of systems like these often have less functionality and fewer features than their web-based counterparts, but McKesson has not yet officially announced this new mobile app so details are still scarce.
During a Congressional hearing last year McKesson’s Senior Vice President of Clinical Development and Strategy, Dr. Jaqueline Mitus, said: “The current regulatory approach for medical devices, however, is not well-suited for health IT. For example, does an iPad that reminds a patient to refill a prescription make it a medical device? What about an application that allows a clinician to access a medical journal or review an x-ray online? Should these applications and the iPad each be subject to FDA regulation?”
This past month Reflectance and Vital Connect also both received clearances from the FDA.
Reflectance Medical secured a 510(k) clearance for a tablet-based version of its Multi-Parameter Mobile CareGuide 3100 Oximeter system. The original device offers a "non-invasive assessment of hemoglobin oxygen saturation and pH in a region of skeletal muscle tissues beneath the oximeter sensor," according to the company. "It interfaces with other patient monitors or smart display devices to display the most recent value of SmO2 and pHm as well as a graphical trend of previous measurements." Reflectance also hasn't yet added the tablet version of its system to its product page.
Finally, Vital Connect received FDA clearance for its Vital Connect Platform, which is the system that supports the company's peel-and-stick, Bandaid-like vital signs monitor HealthPatch. The wearable device captures single lead ECG, heart rate, HRV, respiratory rate, skin temperature, body posturing (fall detection), steps, stress, and sleep staging.