Sorin Group (BIT:SRN) said it’s beginning an immediate launch for the Smartview remote patient monitoring system now that it has FDA approval in hand for the system.
The Italian cardiovascular device maker said the federal watchdog agency OK’d the Smartview system for use with its Paradym RF cardiac rhythm therapy devices.
The system is designed to allow caregivers to monitor data from patients’ CRM implant, wirelessly beaming the data from the device to the clinic via a secure network, according to a press release.
"The introduction of Smartview remote monitoring in the United States is an important milestone for Sorin as we seek to extend our innovative technology offerings to more U.S. healthcare providers and patients,” CRM president Stefano Di Lullo said in prepared remarks.
Sorin announced the 1st implant of a Paradym RF/Smartview device in Canada in 2012. In March Sorin won conditional FDA approval for an investigational device exemption for its SonR cardiac resynchronization device.