Mr Nishith Chasmawala, Founder &CEO, Consure Medical
The company announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market three devices under its novel Qora Stool Management Kit (SMK) platform, to help manage faecal incontinence (FI) in non-ambulatory patients.
FI is the inability to control bowel movements, leading to the involuntary and untimely release of faeces or flatus.
It is an especially embarrassing and distressing condition for nearly 10 million US hospitalized patients and their caretakers.
With current management options, patients are more likely to acquire bedsores, dermatitis, nosocomial infections and extend their length of stay in the hospital.
Such facility acquired complications impact the CMS reimbursement received by these healthcare facilities, costing nearly 2 billion dollars annually.