VitaCon, a medical device manufacturer based in Trondheim, Norway, received clearance from the United States Food and Drug Administration for its bladder scanner. The VitaScan LT USB bladder scanner provides non-invasive, real-time imaging of an individual’s bladder.

With the FDA clearance, VitaScan is cleared for distribution and marketing in the U.S. With its non-invasive imaging technology, the VitaScan provides a safe and affordable alternative to urethral catheters. The system is designed for use in healthcare facilities, clinics, hospitals and homes. It can connect to laptops and tablet computers via its included USB port.

According to a press release by the company, a non-invasive bladder measurement tool is extremely important under currently regulatory conditions. With a traditional urethral catheter measurement, a patient is exposed to an increased risk of a urinary tract infection. Since there is no reimbursement for this infection when it occurs in a hospital, non-invasive measurement technology is a great way to improve patient safety and reduce costs.

In addition to the FDA clearance, VitaCon has also entered into a partnership with Salus. Salus is a lifescience consultancy based in Minneapolis, Minnesota. VitaCon will outsource its marketing and distribution strategy to Salus for the U.S. market.

In prepared remarks, CEO Spencer Lien said, "VitaCon hit our market perfectly, responding to the need for speed, mobility, and cost-effectiveness." He continued, "Our research indicates a void in the marketplace and we are confident the respective channels to healthcare providers will be equally impressed."

References

www.prnewswire.com/news-releases/vitacon-receives-fda-510k-clearance-and...