Monebo and Innolitics Secure FDA Clearance for ECG Library

Monebo Technologies, Inc. and Innolitics announced U.S. Food and Drug Administration 510(k) clearance for a cross-platform ECG arrhythmia analysis library, according to 01net.

The announcement concerns a library that medical device makers can build into their own ECG products. 01net reported that the library supports beat detection, heart rate analysis and rhythm analysis.

FDA clearance announcement

According to 01net, Monebo Technologies and Innolitics secured FDA 510(k) clearance for the ECG arrhythmia analysis library. The companies identified the library as cross-platform.

The reported functions cover beat detection as well as analysis of heart rate and rhythm. Monebo and Innolitics said medical device makers can incorporate the FDA-cleared library into their ECG products.

What the library covers

01net described the cleared offering as an ECG arrhythmia analysis library. The publisher reported beat detection, heart rate analysis and rhythm analysis among the capabilities named in the announcement.

The clearance applies to a library rather than a single ECG product in the supplied report. Device makers may use the library in their own ECG products, according to the companies’ announcement as reported by 01net.

Points for device sales teams

For professionals following ECG technology announcements, the reported clearance identifies Monebo Technologies and Innolitics as the companies behind the cross-platform library. The announcement also names the ECG analysis functions associated with the cleared library.

Sales conversations can distinguish the reported library from the ECG products into which device makers may build it. The supplied report states that the library is FDA-cleared and can be integrated into ECG products by medical device makers.

• 01net reported FDA 510(k) clearance for the library.
• Monebo Technologies and Innolitics announced the clearance.
• The library is described as cross-platform.
• Reported functions include beat detection, heart rate analysis and rhythm analysis.