FDA Clears Sale of Wearable Holter Cardiac Monitor
Mumbai, January 04, 2012 (PTI) Opto Circuits' subsidiary and global leader in automated external defibrillators (AED) and diagnostic cardiac monitoring devices, Cardiac Science Corporation, said it has received US Food and Drug Administration (FDA) clearance for the sale of MySense Heart, a revolutionary wearable Holter cardiac monitor.
The device is small, lightweight and disposable, enabling patients to wear it comfortably for an extended time.
Its ECG signal quality is facilitating early diagnosis of potentially life-threatening heart diseases. It is also designed to be ultra low-cost, permitting a much broader use of the Holter test in the US and especially emerging markets, a company statement said here.
FDA clearance for the product was supported by a multi center clinical trial in the United States and New Zealand conducted in late 2011.
"MySense Heart is yet again a path breaking solution that is designed to manage dynamic challenges of monitoring heart patients. MySense Heart augments our cardiac monitoring suite of products, expanding market addressability and revenues," Vinod Ramnani, Chairman and Managing Director, Opto Circuits.
The company expects to commercially release the product in early 2012 and intend to leverage this revolutionary platform to bring several new products to market, the release said. PTI AP DK
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