Digital respiratory health company Propeller Health has received 510(k) clearance for a sensor and app intended for use with AstraZeneca's Symbicort inhaler for asthma and COPD, the company announced today.

The tool – which, according to the agency, was submitted to the agency in September and greenlit in late March – was developed in a previously unannounced partnership with the Cambridge, England-based pharma company.

WHAT'S THE IMPACT?

Much like Propeller's other connected sensors for various inhaled medications, the Propeller Sensor for Symbicort attaches to a pressurized metered-dose inhaler to passively monitor use. The accompanying app logs and share this information with healthcare providers so that they may appropriately adjust a patient's care plan. But the system also generates insights on triggers and symptoms that the patient can use to self-manage their own care.

“Our partnership with AstraZeneca will give respiratory patients a tool to help manage their condition and increase their medication adherence, a critical factor in keeping people out of the hospital,” David Van Sickle, cofounder and CEO of Propeller Health, said in a statement. “This is an important step in transforming the way people receive preventative care, enabling self-management from home and ensuring that providers have the bandwidth to focus on high-risk patients.”

The Symbicort partnership and clearance is also a key addition to Propeller's respiratory health business. According to a representative of the company, the company's devices now support 90% of inhaled COPD and asthma medications on the U.S. market.

THE LARGER TREND

AstraZeneca isn't a fresh face in the connected inhaler game. The pharma company previously worked with Adherium on another monitoring device called the SmartTouch for Symbicort. The device was first cleared by the FDA in 2017, and received another 510(k) for over-the-counter sale in 2018.

Propeller Health, which was acquired by ResMed in late 2018, has had a number of pharma partnerships over the years, among the most recent of which is a project with Novartis that hopes to become the first asthma treatment in the E.U. that can be prescribed alongside a digital component. Over the past year, the digital health company has also seen its products included in a number of pharmacy health services' connection tools and apps, as well as in a prominent digital health formulary.

Samsung is the latest wearable company to enter the ECG monitoring space, following an announcement on Sunday that the function on its Health Monitoring app got the greenlight from South Korea’s Ministry of Food and Drug Safety. 

This means that Galaxy Watch Active2 users in South Korea will be able to use the tool to detect any heart rhythm irregularities, which could be linked to AFib. 

It’s no secret Samsung has been pushing health features hard in the last few months. In April it scored an MFDS clearance for its cuffless blood pressure monitor feature. The user must first calibrate the feature with a traditional cuff, then the wearable is able to measure blood pressure via pulse wave analysis that is tracked through heart rate monitoring sensors, according to the company. 

Customers in South Korea will be able to digitally send both their ECG and blood pressure measurements to their doctor. According to the company, the new feature will be available on the Galaxy Watch Active2 sometime in the third quarter and will eventually be expanded to the new Galaxy Watches coming down the pipeline.

WHY IT MATTERS 

While the ECG and blood pressure monitoring features are only available in South Korea, it’s hard not to speculate that the tech will be making its way across the Pacific to the U.S. markets and beyond. This will mean seeking FDA clearance and a CE mark for Europe. 

However, the demand for heart health tools in these markets remains there. Afib impacts between 2.7 million and 6.1 million people in the United States and that number is expected to grow, according to the CDC. 

Samsung is pitching this tool as a way to get insights into both blood pressure and heart health.  

“When you pair the advanced hardware of Galaxy watches with innovative software solutions, you can create unmatched experiences – such as, in this case, convenient and accessible health check-ins for millions of users across the world,” TaeJong Jay Yang, corporate SVP and head of the health team, mobile communications business at Samsung Electronics, said in a statement. “This marks just one way in which Samsung is pioneering to give everyone a simple, convenient and informed picture of their overall health and wellness.”

THE LARGER TREND 

The race for ECG features in smart watches began with Apple’s 2018 announcement that its Series 4 Watch had scored FDA clearance for its built-in ECG. 

In January, Withings unveiled its latest smartwatch that included both an ECG feature and Sp02 capabilities – however, the ECG feature is still under review with the FDA. Withings is also interested in the blood pressure monitoring space. Last year it unveiled a connected blood pressure cuff product line with a revamped version of its existing at-home cuff, and a premium cardiac monitor with onboard ECG functionality.

It’s not just traditional consumer wearable companies interested in the space. In August Tel Aviv, Israel-based Biobeat scored 510(k) clearance for a remote-monitoring device capable of measuring the wearer’s blood pressure, oxygenation and heart rate.

But perhaps Omron has the closest functional abilities. It scored a 510(k) clearance for its Blood Pressure Monitor + EKG device in March of 2019, nearly a year after it was originally unveiled. However, unlike Samsung’s tool it is not cuffless.