Four recent FDA clearances in the cardiac monitoring space

By Jonah Comstock
04:16 pm

A number of digital health devices have recieved FDA 510(k) clearance in the last month, including a number of apps and devices in the cardiac health space. Some clearances are updates to companies that have one or more existing clearances, while some are newly cleared devices. Read on for a roundup of connected ECG sensors, medical device companion apps, and wearable patches.

1. St. Jude Medical's ConfirmRx MyMerlin app

St. Jude Medical, a subsidiary of Abbott as of this past January, recieved a new FDA clearance for the MyMerlin companion app to its Confirm Rx Insertible Cardiac Monitor, which was cleared in late September. ConfirmRx is the world's first and only smartphone-connected ICM, according to Abbott.

"Confirm Rx shows what we can do with cutting edge communication technology and the most advanced medical devices that provide new opportunities to improve patient care," Dr. Avi Fischer, divisional vice president and medical director of Abbott's Cardiac Rhythm Management business, said in a statement. "By offering a device that uses Bluetooth wireless technology from the patient's smartphone, we can help physicians easily and remotely diagnose potentially dangerous abnormal heart beats without requiring the patient to use a separate or cumbersome recording device."

MyMerlin is available on iOS and on Android. The device automatically sends data to the app which, in turn, sends data to the user's care provider at regular intervals. Patients can also record symptoms in the app and manually send a recording to their physician.

2. Cardiac Designs' ECG Check Universal

Cardiac Designs recieved over-the-counter FDA clearance back in 2013 for a smartphone-connected 1-lead ECG event monitor to AliveCor's Kardia Mobile. Now the Park City, Utah-based company has received clearance for two new updated devices, ECG Check Universal and ECG Check Universal Plus. 

One update is that ECG Check was only for iPhone, while both new devices can run on Android as well. In order to accomodate different sizes of phones, the device has also been redesigned to be a standalone device rather than a phone case. The company has also added a rechargeable battery, rather than a replaceable battery like the original model had. Finally, the Universal Plus will have the ability to transmit ECG readings on an analog phone line (in addition to the cellular transmission option), and will have a button that can be used to send stored files to a provider or to delete all stored recordings.

Cardiac Designs had a less positive run-in with the FDA in 2015, when it received a warning letter about its lack of design validation and problems with its risk management policies.

3. Rooti Labs' Rooti Rx

Tapei, Taiwan-based Rooti Labs received its first FDA clearance for its wearable continuous ECG monitor, RootiCare, and the RootiLink app that allows users to transmit the readings from the device via wifi.

"RootiRx uses a single-lead ECG sensor to achieve a simple and accurate recording of a patient's vital signs for up to 7 days," the company explains on its website. "Because of its portability and ease of use, RootiRx opens a unique window that allows doctors to monitor their patients in their daily lives."

In addition, Rooti will use the data collected from devices to improve their efficacy over time.

"Our innovative RootiCare platform is an intelligent monitoring solution," the company writes on its website. "It abstracts clinical-grade biometrics from the ECG signal and uses deep learning to give insights derived from thousands of clinical cases, helping doctors leverage the collective intelligence of the medical community."

4. Cardiomedix ECG Sentinel

Cardiomedix received clearance for ECG Sentinel, an ECG device that monitors the user and sends data to their provider via a smartphone. 

"Cardiomedix ECG Sentinel System is a self-use, 2-lead ECG continuous acquisition and transmission system," the clearance document states. "The Sentinel device connects via Bluetooth to a proprietary mobile phone-based, dedicated ECG acquisition, storage, and transmission application. The phone application facilitates the self-use of the device by providing messages and alerts for specific parameters."

Evanston, Illinois-based Cardiomedix has been offering telehealth tools to care providers since 1988, according to the company website.