FDA Clearance And U.S. Commercialisation For Vitacon Bladder Scanner

Norwegian company Vitacon has announced the FDA 510(k) clearance of its clever non-invasive bladder scanner, which seems to tap into new reimbursement guidelines. The company has employed a U.S. partner to drive its commercialisation efforts.

In short

Bladder device specialist Vitacon AS has received FDA (510k) clearance for  its VitaScan LT USB bladder scanner. The company has also announced signing a marketing and distribution partnership with Minneapolis-based life science advisory firm, Salus Consillium LLC which it expects will light a fire under its efforts to commercialise its products in the United States.

Background 

Non-invasive bladder scanning has become a valuable diagnostic tool. Measuring bladder volume helps avoid indwelling urethral catheters, a major cause of infection. CAUTI (catheter-associated urinary tract infection) treatment is no longer reimbursed (in U.S.) if it happens while a patient is hospitalised, thus a major incentive exists to prevent it.

Founded in 1985 in Trondheim, Norway, Vitacon develops products to treat incontinence and diagnose bladder dysfunction. The company has moved into diagnostic ultrasound and recently launched the VitaScan series of ultrasound scanners offering what it says are flexible and cost-effective solutions in bladder volume measurements.

VitaScan LT enables real-time bladder volume measurement in hospitals, clinics, and home health. It connects via USB to laptop and tablets, providing nearly limitless storage and data transmission capabilities. VitaScan software utilises intelligent targeting algorithms enabling personnel with limited training to obtain accurate measurements in seconds.

Vitascon’s new marketing partner, Salus Consilium, LLC specialises in advising new medical technology ventures and established companies on growth strategies and technology management and has been selected by Vitacon to implement a US marketing and distribution strategy. Salus will be responsible for pre-sales support, logistics, and customer service for a nationwide network of distributors.

Company comments 

“The selection of Salus is essential to our growth,” says Kristin Waro, CEO of Vitacon. “We found their approach unique as they not only created a thorough strategy, but also have the expertise and distribution connections to execute the plan.”

Spencer Lien, Salus CEO, says, “Vitacon hit our market perfectly, responding to the need for speed, mobility, and cost-effectiveness. Our research indicates a void in the marketplace and we are confident the respective channels to healthcare providers will be equally impressed.”

Website: www.vitacon.com

Website: www.TeamSalus.com

Source: Salus Consilium, LLC., PR Newswire

published: November 19, 2012 in: Approval/Clearance, Launches / Withdrawals, Urology

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