Roundup: FDA digital health clearances and news in Q1 2018

By MobiHealthNews
01:39 pm

In the last quarter the FDA gave the nod to 10 digital health devices. Innovations that aimed to help diabetes management were popular, ranging from the first integrated continuous glucose monitor, which was put out by Dexcom, to Glooko’s insulin titration tool. 

Not all FDA news this quarter was good news. In February Roche’s Accu-Check Connect Diabetes Management App was recalled by the FDA for a fifth time. This time the app was recalled because of a bug that could lead users to self-administer inappropriate doses of insulin. And in March, a warning letter came to light from FDA to online vision startup Opternative.

While there were a number of new tools cleared by the FDA this quarter, there was also a lot of movement towards laying out a speedier clearance process.

Last summer the FDA began talks around implementing a new Pre-Cert program that would allow for certain companies that the FDA has deemed responsible and safe in their development to build products without each new device undergoing the FDA clearance or approval process. In the fall, a pilot started the agency down the road to the new changes. This winter, the players in the medical device industry got to sit down and talk about the future of the program. 

Though some have criticized how the pilot was rolled out, for the most part industry players have been in support of the changes. 

“We have a situation where the manner in which the FDA is reviewing software is going to have match the way the way our industry makes software, and so that was a big part of this discussion,” Morgan Reed, the President of ACT The App Association, who attended the two-day workshop, told MobiHealthNews. 

But the FDA has also seen some backlash from its new initiatives. At the end of last quarter the FDA released their new CDS draft guidances, which outlined forms of the CDS which won’t be regulated based on the degree of human involvement instead of based on risk. For example, according to the draft the CDS software won’t be regulated if the physicians can independently review and understand the basis of the software decision. 

This quarter the Clinical Decision Support Coalition released a comment broadly criticizing the FDA’s draft guidance, nothing the that draft would expand the scope of FDA regulations, and that it fails to take a risk-based approach, lumping in many low-risk programs already on the market. The comment concluded by urging the FDA to revise the draft. 

For now, though, companies are still traveling the traditional route. Here is a list of digital health products cleared by the FDA in the first quarter covered by MobiHealthNews:

toSense’s CoVa Monitoring System 2, a remote patient monitoring necklace that tracks vitals and cardiac fluids, received a second FDA clearance this quarter. The new clearance will allow the company to update the software to add a new feature that measures stroke volume and cardiac output to the original product. The clearance also lets the device connect to a mobile application that allows medical professionals to remotely view measurement data and single-lead ECG wave forms. 

Empatica's Embrace, the consumer-facing wearable for epileptic seizure detection, received 510(k) clearance from the FDA in January. The wearable, which has already been used in clinical trials by pharma company Sunovion, has a long history that's led it up to this milestone. The clearance is as a prescription, not an over-the-counter device, which means users will have to secure a prescription from their neurologist to use the device's seizure-detecting features.

Smart thermometer and connected health company Kinsa launched a new wireless version of its device, called Kinsa QuickCare, after securing FDA clearance. The QuickCare thermometer can read temperature in eight seconds — down from 10 seconds for the old model. It preserves most of the software features in the original Smart Stick, including Kinsa’s partnership with Sesame Street and the bubble game that was introduced with the original device to distract children while the thermometer does its work.

Digital diabetes care company Glooko announced that its Mobile Insulin Dosing System (MIDS) — an app-driven tool that recommends insulin dose adjustments using data collected directly from a patient’s blood glucose meter — has been cleared by the FDA. The MIDS module allows clinicians to create a customized treatment plan and send it to Type 2 diabetes patients directly through the company’s unified mobile diabetes management app. Instead of relying on patients to input their own fasting blood glucose, however, the system pulls readings from the patient’s blood glucose meter. 

The FDA announced in February that it will permit marketing of’s Contact, a clinical decision support (CDS) tool that analyzes CT results and highlights cases that may have experienced a stroke. The CDS application was submitted through the agency’s de novo premarket review pathway, and as such creates a new regulatory classification for similar AI-driven platforms to come. The FDA’s decision came just a couple of months after the agency released its long-awaited, and somewhat controversial, draft guidance on CDS outlining which tools would and would not be regulated by the agency.

New York and Palo Alto, California-based MemoryMD has received FDA clearance for NeuroEEG, a wireless amplifier that transmits EEG signals to computers and cloud-based databases via Bluetooth. The other half of MemoryMD's offering, a disposable EEG cap called NeuroCap, is still awaiting clearance.

The FDA expanded its indication for Medtronic’s Guardian Sensor 3, allowing patients to wear the sensor on their upper arm. The sensor is part of Medtronic’s MiniMed 670G system, and is currently the only continuous glucose monitor approved by the FDA to control automated insulin delivery via a hybrid closed loop system. Along with the added convenience of the new sensor site, the company said in a statement that the new location is also more accurate, demonstrating a mean absolute relative difference (MARD) of 8.7 percent following calibration.

Medtronic also received FDA clearance for Guardian Connect, its smartphone-connected standalone CGM for patients who use multiple daily injections (MDI) for their insulin. Medtronic's closed-loop system for pump users was cleared in 2016. The Guardian Connect system consists of the Guardian Sensor 3 and attached transmitter, which sends continuously-collected glucose data via Bluetooth to the Guardian Connect app on a user's smartphone. The app can alert patients about high or low blood sugar 60 minutes in advance of a hyper- or hypoglycemic event.

University of Stanford spinout PhysioWave received FDA clearance for its pulse wave velocity (PWV) cardiovascular analyzer scale, which measures the stiffness of the vessels transporting blood from the heart to the body. The new technology will come in the form of a scale. The new scale, called the PhysioWave Pro, also measures pulse rate, weight, and BMI, and according to the website uses a dedicated tablet as user interface. The company claims that its technology is able to identify when someone is at high risk of cardiovascular disease. 

This quarter Dexcom got the long-awaited nod from the FDA to market their Dexcom G6, an integrated continuous glucose monitoring system (iCGM), making it the first interoperable CGM to get the designation. As of today, the Dexcom G6 is the only FDA-authorized iCGM that can integrate with other compatible medical devices and electronic interfaces, such as automated insulin dosing systems, insulin pumps, blood glucose meters, or other electronic devices used for diabetes management, according to a statement released by the FDA.


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