Israeli heart monitoring company, Aerotel Medical Systems has received the CE Mark approval for its new ECG devices, HeartView P12/8i and HeartView 12L.
Background
Imagine being able to transmit comprehensive ECG data from any place at any time. The potential benefits are enormous, especially for patients with paroxysmal conditions that don’t show up on demand at hospital appointments.
Aerotel’s newly CE marked systems enable ECGs to be recorded and transmitted automatically via Bluetooth to Aerotel’s Mobile CliniQ App. The ECG data is then automatically sent from the mobile device to a cardiac call center for immediate diagnosis.
The HeartView devices allow diagnosis of cardiac symptoms, remote monitoring of chronic heart patients, recording and transmission of an ECG to a cardiac call center and cardiac analysis for clinical studies.
Developed to expand the Aerotel Medical Systems family of Heartline ECG devices, the company says it offers monitoring services with a higher level of ECG quality, enabling it to expand its services to newer areas.
The HeartView™ 12L, a high-resolution 12-lead ECG recorder and transmitter for professional use is one of the world’s smallest and most powerful ECG monitors.
The new HeartView™ P12/8i, an ECG event recorder-transmitter for personal use, is a powerful ECG device with high-resolution 12-lead ECG recording technology, specifically designed for patient use.
Both devices remain investigational in the United States and so not available for sale.
Company comments
“Aerotel is proud to present the most advanced ECG mobile solutions currently available on the market,” said David Rubin, Aerotel’s President and CEO. “The two new mobile devices are aimed at improving patients’ quality of life, enabling people who previously had to remain in the hospital to get on with their normal lives.”
Source: Aerotel Medical Systems (1988) Ltd., PR Newswire
published: March 24, 2014 in: Approval/Clearance, Cardio