FDA clears Toshiba Medical’s Aplio i900 cardiovascular ultrasound

Canon‘s (NYSE:CAJ) Toshiba Medical subsidiary said today it won FDA 510(k) clearance for its Aplio i900 cardiovascular ultrasound system and launched the device in the US.

The Tustin, Calif.-based medical subsidiary said the Aplio i900 is designed to allow clinicians to assess myocardial function or quantify complex valvular lesions with a greater depth and detail than previous versions.

“The Aplio i900 presents a real breakthrough in expanding the clinical utility of ultrasound, offering cardiologists a new tool for fast, safe and confident diagnoses even in technically difficult patient exams. The system combines crystal clear image quality with cutting edge clinical applications to make work flow and help clinicians provide the best possible patient care,” Toshiba America Medical Systems ultrasound biz director Dan Skyba said in a press release.

Earlier this month, Toshiba Medical said it launched the PM Only Service Agreement preventive maintenance program designed to maintain imaging equipment for healthcare providers.

The new service from Toshiba Medical is designed to enable providers to fulfill and document that they are complaint with Centers for Medicare & Medicaid Directive and The Joint Commission guidelines that imaging equipment meets manufacturer’s specifications, the company said.

Toshiba Medical said its PM Only service will provide ongoing preventive maintenance and service for imaging equipment, as per manufacturer guidelines so that providers can stay compliant and avoid penalizations.

The post FDA clears Toshiba Medical’s Aplio i900 cardiovascular ultrasound appeared first on MassDevice.

from MassDevice http://ift.tt/2mYjdVG