Monebo and Innolitics Secure FDA 510(k) Clearance for a Cross-Platform ECG Arrhythmia Analysis Library

Medical device makers can now build an FDA-cleared library for beat detection, heart rate and rhythm analysis into their own ECG products.

AUSTIN, Texas--(BUSINESS WIRE)--Monebo Technologies, Inc. and Innolitics today announced that the U.S. Food and Drug Administration has granted 510(k) clearance for the Kinetic Software Library (K260640), Monebo’s ECG analysis library for medical device manufacturers.

The Kinetic Software Library provides ECG signal processing and analysis, including QRS detection, ectopic beat detection, QRS feature extraction, heart rate measurement and rhythm analysis. It is intended for use by qualified medical professionals for assessing ECG data. Manufacturers integrate the library into their own ECG devices through a simple cross-platform API.

Monebo has developed ECG analysis software since 2002. Its earlier FDA-cleared libraries sit at the start of a long line of cleared ECG devices: 51 later clearances trace their predicate lineage back to Monebo.

Monebo built and tested the Kinetic Software Library. Innolitics led the FDA regulatory strategy, guided Monebo’s engineers through the software and cybersecurity documentation, and managed all FDA interactions.

“Monebo’s arrhythmia analysis has been inside ECG products for more than twenty years,” said Dale Misczynski, CEO of Monebo Technologies. “George and David knew what the FDA expects from software like ours, and they guided us every step of the way.”

“Clearing a library that other companies build into their devices takes software and regulatory expertise working together,” said J. David Giese, Partner at Innolitics. “Monebo’s library gives ECG device manufacturers a cleared starting point, so they can spend their effort on their own products instead of rebuilding arrhythmia analysis from scratch.”

George Hattub, Senior Regulatory Affairs Project Manager at Innolitics, led the submission, his 72nd 510(k) clearance. “It was an honor to help bring this software to a new generation of devices,” said Hattub upon receiving the clearance.

Monebo is now making the Kinetic Software Library available to ECG device manufacturers and will continue partnering with Innolitics as the library grows.

About Monebo Technologies

Founded in 2002 and based in Austin, Texas, Monebo Technologies designs, develops and licenses ECG analysis software for integration into medical devices and other applications. Learn more at monebo.com.

About Innolitics

Innolitics is an FDA regulatory consulting and software engineering firm that helps medical device companies bring software-enabled products to the U.S. market. From regulatory strategy and FDA submissions to software engineering and cybersecurity, Innolitics has built and FDA cleared more than 70 devices since 2012. Learn more at innolitics.com.