Medical Device News Magazine

5 Cardiovascular SaMD Cleared in 2023 | By Randy Horton, Chief Solutions Officer, Orthogonal

About Medical Device News Magazine

About Medical Device News Magazine. We are a digital publication founded in 2008 located in the United States.

Advertise with Medical Device News Magazine! Join Our #1 Family of Advertisers!

We pride ourselves on being the best-kept secret when it comes to distributing your news! Our unique digital approach enables us to circulate your...
Cardiovascular SaMD
Randy Horton, Chief Solutions Officer, Orthogonal

By Randy Horton is Chief Solutions Officer at Orthogonal,

Just like hardware medical devices, Software as a Medical Device (SaMD) are grouped together  across the FDA’s 16 medical specialty panels. In our firm’s journey to create a comprehensive list of all FDA-cleared SaMD, this article takes a quick look at five interesting SaMD from the Cardiovascular panel that were cleared by the FDA in 2023. The common thread among these recently cleared SaMD is a focus on remotely monitoring patients and alerting them or their clinicians when irregular heart rhythms or dangerous heart events occur.

Orthogonal estimates that our list of SaMD may only be ~10% complete at this point. Help us improve our list by submitting any SaMD you are aware of using this form or by emailing us at SaMD-list@orthogonal.io.

Remote monitoring of ICU patients: T3 Platform Software

Company: Etiometry
Decision Date: July 7th, 2023
FDA Summary: K223578

Clinical decision support software provider Etiometry received clearance for the latest version of their intensive care software solution known as T3 – Tracking, Trajectory and Trigger.

This updated SaMD, first cleared in 2015, is composed of two parts. The T3 Data Aggregation and Visualization module collects, presents and stores cardiac data from multiple sources in an ICU setting. Among the kinds of data the T3 system can pull from sensors and medical devices are a patient’s arterial blood pressure, cardiac output, oxygen saturation, pulse rate and atrium pressure. Clinicians can use this software to remotely view a patient’s status in near real-time.

The second part of the T3 Platform is the T3 Risk Analytics Engine, which calculates the probability of life-threatening cardiac conditions and directs clinicians to intervene. The engine examines physiologic data and laboratory measurements received by the Data Aggregation and Visualization module to monitor for inadequate delivery of oxygen, inadequate ventilation of carbon dioxide, presence of acidemia and presence of hyperlactatemia.

Heart monitoring on your schedule: Samsung Galaxy Watch and Apple Watch’s Irregular Heart Rhythm Notification Features

ECG Monitor Application with Irregular Heart Rhythm Notification

Company: Samsung
Decision Date: May 2nd, 2023
FDA Summary: K230292

Irregular Rhythm Notification Feature
Company: Apple
Decision Date: July 21st, 2023
FDA Summary: K231173

Tech giants Apple and Samsung not only compete with their iPhone and Galaxy smartphones but also with their Apple Watch and Galaxy Watch smart watches. The Apple Watch was the first to add a built-in electrocardiogram (ECG) and heart monitoring feature in 2018; Samsung wasn’t far behind with their own ECG app in 2020. Both watches perform a single-channel ECG and store recordings on a companion health app on the user’s smartphone.

ECG App on Apple Watch Series 4.

In 2023, Samsung received clearance for their ECG watch app with an irregular heartbeat notification feature, bringing the Galaxy Watch’s app in line with the Apple Watch’s. This feature passively listens to the user’s heart rate and pulse and alerts when an irregular heartbeat could indicate an occurrence of atrial fibrillation.

Samsung Health Monitor App on Galaxy Watch.

Apple’s 2023 clearance for their app allows them to implement a Predetermined Change Control Program (PCCP) for their Irregular Rhythm Notification Feature algorithm. PCCP is a new regulatory tool that names very specific modifications that Apple can make to their algorithm/device without filing for another clearance from the FDA.

Machine Learning cardiovascular software: Viz HCM

Company: Viz.ai
DEcision Date: August 3rd, 2023
FDA Summary: DEN230003

The first FDA-cleared device of its kind, Viz HCM is a cardiovascular Machine Learning-based notification software. Its AI algorithm reviews 12-lead ECGs across an entire hospital system to identify signs of hypertrophic cardiomyopathy (HCM), a heart disease that causes the thickening of the heart muscle and can lead to a sudden and early death. Once a patient’s ECG is flagged for HCM, Viz’s mobile app platform alerts the appropriate clinician, who can view the ECG reports and follow up with the patient.

Viz app

Scoring heart health: SignalHF

Company: Implicity
Decision Date: October 25th, 2023
FDA Summary: K230842

SignalHF’s algorithm scores the risk of heart failure by sampling data from a patient’s compatible cardiac implantable electronic devices and electronic health record data. Based on its calculations, SignalHF can predict a potential heart failure around thirty days before it occurs, long before the patient is hospitalized. This enables clinicians to preventatively treat patients at home and avoid the health consequences and costs of a heart attack.

SignalHF dashboard. Source: Implicity

Conclusion

Whether reacting to atypical heart events or predicting the likelihood that they’ll occur, SaMD can play an important role in cardiovascular care. We anticipate that the FDA will clear more cardiovascular SaMD that leverage AI and Machine Learning algorithms to improve their predictive abilities, enabling clinicians to treat patients before adverse heart conditions occur.

This selection of SaMD was taken from Orthogonal’s Ultimate Running List of every FDA-cleared SaMD. Even with over 500 SaMD cataloged, our journey to record all SaMD on the market in the U.S. is far from over. Help us complete our list by filling out this form or emailing us at SaMD-list@orthogonal.io.


Editor’s Note

 

Randy Horton is Chief Solutions Officer at Orthogonal, a software consulting firm that improves patient outcomes faster by helping MedTech firms accelerate their development pipelines for Software as a Medical Device (SaMD), digital therapeutics (DTx) and connected medical device systems. Orthogonal makes that acceleration happen by fusing modern software engineering and product management tools and techniques (e.g., Agile, Lean Startup, User-Centered Design and Systems Thinking) with the regulated focus on device safety and effectiveness that is at the heart of MedTech.

Horton serves as Co-Chair for AAMI’s Cloud Computing Working Group, as well as AAMI CR:510(2021) and the in-process Technical Information Report #115, all of which address how to safely move medical device computing functions into the cloud. He is a frequent speaker at conferences and webinars, including events hosted by AdvaMed, AAMI, HLTH, RAPS and the Human Factors and Ergonomics Society (HFES).

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Other News

Shoulder Innovations Further Strengthens IP Portfolio in Key Areas with Recent Patent Grants

"These recent grants further strengthen key patent families that are foundational to our technology, and we are pleased the USPTO continues to recognize our meaningful innovation in the shoulder arthroplasty segment," said Rob Ball, CEO of Shoulder Innovations. "This noteworthy expansion of our IP position represents the culmination of over 10 years of research and development, and we are proud of our team for their continued dedication to creating practical solutions for shoulder surgeons and advancing patient outcomes."

Radical Catheter Technologies Presents Analysis of Disruptive, Recently FDA-Cleared Endovascular Technology at the Society of NeuroInterventional Surgery 21st Annual Meeting

This new catheter, the first product commercialized from this novel technology platform, is designed to enable access to the blood vessels in the brain for both femoral and radial access. A multi-center analysis of this disruptive technology is being presented today at Society of NeuroInterventional Surgery 21st annual meeting. In addition, the Company confirmed the closing of a $20 million financing round led by NeuroTechnology Investors, which will be used to scale the company and expand the Radical platform notes Radical Catheter Technologies.

Rapid Medical™ Completes Initial Neurovascular Cases in the USA Following FDA Clearance of Its Active Access Solution

“With DRIVEWIRE, our design goal was to bring new levels of access and control to the interventional suite while improving best-in-class guidewires,” comments Giora Kornblau, Chief Technology Officer at Rapid Medical. “When physicians are looking for technologies that increase the clinical possibilities and safety for the patient, we want Rapid to be the first place they look.”