Improving Patient Outcomes: Notable SaMD ClearedImproving Patient Outcomes: Notable SaMD Cleared

Software as a Medical Device (SaMD) is finding its way into more and more patients’ hands through its ability to piggyback off the computing power of the ordinary and ubiquitous smartphone. SaMD can help patients manage their symptoms and adhere to the treatment by engaging them with thoughtful user experience/user interface (UX/UI) design, features that organically drive interaction, and functions that meet patients’ needs in their daily lives. 

In Orthogonal’s ongoing quest to catalog every FDA-cleared SaMD, this article takes a look at five patient-intended SaMD that received FDA clearance in 2023 and how they demonstrate the ways in which this technology can drive patient outcomes and improve access to healthcare.  Consistent with past SaMD trends we have seen, three of the devices described below are in the diabetes space while two are in the remote patient monitoring space.

We estimate that our list may only be ~10% complete at this point. Do you know of any SaMD missing from our list? Help us improve our list by submitting any SaMD you are aware of using this form or by emailing us at [email protected]. 

ECG on the Go: Samsung Galaxy Watch’s Health Monitor App with Irregular Heart Rhythm Notification 

Company: Samsung 

Decision Date: May 2nd, 2023

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FDA Summary: K230292

Samsung’s Health Monitor App for its Galaxy Watch product line was originally cleared by the FDA in 2020 as a device that performs a single-channel electrocardiogram (ECG) using technology embedded in the smart watch. In 2023, it received clearance for a new feature called the Irregular Heart Rhythm Notification. This feature enables the Galaxy Watch to passively analyze a user’s heart rate and pulse to identify irregular heartbeats that could indicate atrial fibrillation. If identified, the app prompts users to perform an ECG. ECG data is stored within a companion app for Samsung Galaxy phones. 

Atrial fibrillation is the most common type of irregular heartbeat; according to the CDC, 12.1 million people in the U.S. will have it by 2030. The Samsung Health Monitor App’s ECG capabilities enable patients to monitor their heart health without having to schedule an appointment with their doctor and without needing to be hooked up to a bulky ECG machine. This app demonstrates the strength of SaMD to meet patients where they are in their busy lives. 

Modular Patient Monitoring: Huma 

Company: Medopad

Decision Date: June 2nd, 2023

FDA Summary: K230214

Huma is a remote patient monitoring platform designed to scale virtual care for patients while taking the burden off of the healthcare system. By tracking a patient’s symptoms and vital signs, the Huma app can flag data for triage or decision-making, enabling clinicians to intervene early and virtually, avoiding an unnecessary trip to the doctor’s office for the patient. Automated coaching and a library of medical information help patients stay informed about their own health. 

Tidepool Loop from Tidepool, 501(c)3 nonprofit, is the first device-agnostic automated insulin dosage app, making it fully interoperable with multiple manufacturers’ continuous glucose monitors (CGM) and insulin pumps. Built on the “foundation of the do-it-yourself diabetes community’s original Loop app,” Tidepool Loop enables patients with Type 1 diabetes to choose the CGM and insulin pump that works for them based on their own habits, familiarities, and needs. With forthcoming support on smartphones and Apple Watch, Tidepool is set to provide autonomy for patients with Type 1 diabetes.

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Huma states that its sleek patient-facing app boasts a 90-95% adherence and retention rate. With an accessible and easy-to-use dashboard featuring “direct access to key metrics and health indicators,” patients who use Huma can stay engaged with their care, with the goal of leading to better health outcomes.

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For Patients, by Patients: Tidepool Loop

Company: Tidepool

Decision Date: January 23rd, 2023

FDA Summary: K203689 

A wide variety of SaMD exist to aid patients with diabetes in managing their insulin dosages and blood glucose levels. Unique among them is a diabetes management SaMD created by patients for patients, designed with the lived experiences of Type 1 diabetics in mind.  

All-in-One Diabetes Assistant: BlueStar Rx

Company: Welldoc

Decision Date: July 28th, 2023

FDA Summary: K230813

Another diabetes management app, BlueStar Rx from Welldoc is a digital diabetes assistant that combines the “diabetes self-management” features of the previous BlueStar and BlueStar Rx apps with “automatic tracking of insulin delivery.”

BlueStar Rx analyzes blood glucose test results and provides guidance to patients with Type 1 or Type 2 diabetes on improving their self-management of their condition, as well as promoting adherence to medication. It is highly interoperable, connecting with devices such as fitness trackers to observe a wide variety of vital signs and provide insights to the patient’s care team. With the app’s frequent reminders and friendly tone, patients are empowered to make decisions to better manage their symptoms and lower their overall A1C number.  

Modernizing Traditional Management Methods: Insulia

Company: Voluntis

Decision Date: December 12th, 2023

FDA Summary: K232451

While CGMs and connected insulin pumps have made the management of blood glucose and insulin dosage levels far easier for many patients, there are those who still prefer the traditional methods of finger sticking and insulin pens. Insulia provides access to advanced algorithms without forcing patients to give up their familiar diabetes management tools. 

Insulia recommends basal insulin dosages and suggests carbohydrate intake based on user-reported data of blood glucose levels, past insulin dosages and hypoglycemia values. Insulia is customizable by a patient’s healthcare provider, who can set individualized target blood glucose levels and insulin dosages in the app.  

Insulia bridges the gap between traditional diabetes management methods and modern dosing calculators. It’s a perfect example of how SaMD can fit into the lifestyle patients are accustomed to and encourage them to stick with a treatment routine that works for them. 

Conclusion

Whether they encourage patient adherence through interactive menus, friendly automated reminders or ease of use, the SaMD discussed in this article all have one goal: improving patient outcomes. Orthogonal believes that widespread adoption of SaMD will usher in a new, healthier paradigm for patients and healthcare providers. We’re excited to see what SaMD MedTech and digital health companies will receive clearance for in 2024!

This selection of SaMD was taken from Orthogonal’s Ultimate Running List of every FDA-cleared SaMD.