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Pittsburgh’s ClearCount gets FDA approval for lower-cost sponge-detection system

ClearCount Medical Solutions has received clearance from the FDA for its SmartWand-DTX sponge-counting system, a smaller, lower-cost, more-portable alternative to its sponge-detection system already on the market.

PITTSBURGH, Pennsylvania — ClearCount Medical Solutions has received clearance from the U.S. Food and Drug Administration for its SmartWand-DTX sponge-counting system, a smaller, lower-cost, more-portable alternative to its sponge-detection system already on the market.

The SmartWand uses radio-frequency identification (RFID) technology coupled with chips embedded in sponges to allow surgeons and nurses to count and detect sponges used in operations. The goal is to help hospitals avoid leaving sponges inside patients, a type of so-called “never event“– a seriously and costly medical error that should never happen.

In 2008, the federal government initiated a policy of no longer reimbursing hospitals for procedures in which never events occur. Many private insurers followed suit.

ClearCount’s other product, the SmartSponge system, was cleared by the FDA in 2007. The SmartSponge system counts all the sponges to be used in an operation before it starts, then reconciles that number with the number of sponges returned to a receptacle after the surgery. The system allows for continuous monitoring of sponge counts during an operation and creates a report once the surgery is complete, said Jim Sweeney, ClearCount’s vice president of marketing.

In contrast, the SmartWand can be used to count sponges, but doesn’t provide an “in-and-out” reconciliation of the number of sponges used in a procedure, Sweeney said.

The SmartSponge and SmartWand products are distributed by Illinois-based Medline Industries.

In October, ClearCount closed on $3.4 million of financing, led by Draper Triangle Ventures. A year before that the company raised a $4.1 million round of funding, also led by Draper. Sweeney declined to provide the total amount of funding the company has received since its founding in 2004.