In the first quarter of 2017, we tracked seven digital health-related FDA clearances. While the list isn’t long, it’s varied and relatively novel – from app and device integrations for diabetes treatment to a vest that maps cardiac rhythms. The beginning of this year also rang in some big changes, as the Trump Administration took root and nominated Dr. Scott Gottlieb as FDA deputy commissioner. Gottlieb has made it clear that he believes regulation for mobile health should be the exception, not the rule.
As to a solution, Gottlieb has advocated passing responsibility for digital health tools away from the FDA entirely, either to a newly created government group or to the industry to self-regulate. This is a solution that can sometimes evoke eyerolls, but Gottlieb contends that it’s exactly what was done with EHRs at a time when they were a political priority and those in power at HHS didn’t want their adoption to be stymied by FDA regulation.
The FDA itself is also re-examining its role in times of changing policies, and announced it is considering the creation of an Office of Patient Affairs, which would be focused on soliciting the perspectives of patients and taking those insights into account as it sets regulatory policy.
In another move to update how it functions, the FDA announced a joint initiative with IBM Watson Health. The two organizations will look at the use of blockchain technology to share health data to ultimately improve public health. In the beginning, the two-year collaboration will focus on oncology data, pulling together and exchanging data from a variety of sources including that from clinical trials, genomic data, EMRs, and from miscellaneous Internet of Things data from wearables, apps and connected devices.
Here are the seven companies that received FDA clearance in the first quarter of 2017:
Medtronic received FDA 510(k) clearance for its sensor-enabled vest – a single-use, disposable wearable called the CardioInsight Noninvasive 3D Mapping System.The vest features 252 electrode sensors to provide a wide range of electroanatomic 3D maps of the upper and lower chambers of the heart, and works by pairing body surface electrocardiogram (ECG) signals from the chest, then combining them with data from a computed tomography (CT) scan of the heart and connecting to the CardioInsight Workstation. It comes in four sizes, contouring to the wearer’s body and enabling continuous, simultaneous panoramic mapping of both atria or both ventricles (which can’t be done with the catheter method). More
San Diego, California-based ResMed received FDA 510(k) clearance for its small, portable continuous positive airway pressure (CPAP) device, the AirMini. Designed to be used as an secondary device – particularly during travel or any other time the user doesn’t have access to or doesn’t want to bring their full-size CPAP device along – the AirMini is ResMed’s first FDA-cleared device and will be launched later this year. The device, which is not yet commercially available, comes in a case about the same size as one used to carry sunglasses. More
The US Food and Drug Administration gave the green light for a non-prescription version of BlueStar, WellDoc’s mobile diabetes management platform.Through this 510(k) class II clearance, WellDoc can offer BlueStar and BlueStar Rx, allowing the company to offer the product through more channels. Both versions analyze diabetes data entered by the patient, comparing past data trends to form personalized guidance and creating a summary of curated data analytics to the healthcare team for clinical decision support, but the non-prescription version does not feature the insulin calculator that the full version does. More
Indianapolis-based pharma company Eli Lilly recieved FDA 510K clearance for a new mobile app called Go Dose, a diabetes management and insulin dosing app for users of Humalog, Lilly's rapid-acting insulin. The clearance is for prescription use, but includes two versions of the app: Go Dose, for patients, and Go Dose Pro, for healthcare providers. More
UK-based cognitive assessment company Cambridge Cognition received FDA clearance for Cantab Mobile, the company's iPad-based assessment tool for memory issues in older adults. The app, which already had a CE Mark, received FDA clearance January 13th. Cantab Mobile is a 10-minute test -- based on the Pairs Associates Learning or PAL test -- administered via a tablet that puts the user through three different exercises to test their memory. It's meant to serve as an early warning system for conditions like dementia and Alzheimer's. It also builds in a test for depression, allowing the test to distinguish between mood disorders and memory impairment. More
VivaLnk, a Santa Clara-based connected health startup, received FDA clearance for its first device, a peel-and-stick continuous thermometer for children called Fever Scout. VivaLnk announced Fever Scout at CES 2015 and originally planned to launch it that year, but delayed the launch more than once. FDA clearance could mean the device will finally hit the market soon. More
Medical device maker Zoll Medical Corporation received FDA premarket approval for a wearable external defibrillator for use in the hospital. Zoll got approval last year for its LifeVest, a similar product designed for home use. The system monitors the user's heart rhythm for signs of ventricular tachycardia or ventricular fibrillation. If it detects an irregularity, it performs a check to see if the wearer is conscious, giving them a chance to cancel the process if they are. If the wearer doesn't respond in a minute, the system delivers a shock. If the first shock doesn't return the heart rhythm to normal, it will administer another. More