Vasomedical-BIOX 2301 for Monitoring of ECG and Blood Pressure Gets 510(k) Clearance

The FDA has given regulatory clearance to Vasomedical‘s BIOX 2301 Combined ECG Holter and Ambulatory Blood Pressure Monitoring Recorder and Software Analysis System. The 2301 is currently approved for sale in Europe, and is the only FDA cleared device which combines holter-type ECG recording and blood pressure monitoring.
Some stats from the product page:

Modes Of Operation: ECG, ABPM & Combined ECG & ABPM

Interactive 3-Channel ECG & ABPM recording & storage for 24 Hours

Wireless infrared port for real-time ECG & ABPM verification

Pacemaker detection

Press release: Vasomedical Announces FDA 510(k) Clearance on the First Combined ECG Holter and Ambulatory Blood Pressure Monitoring System…
Product Page: Vasomedical-BIOX 2301…