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FDA Approves Polymedco’s OC-Sensor Diana

Polymedco has received FDA 510(k) clearance for its OC-Sensor Diana, a high throughput automated system for the immunoassay fecal occult blood test (FIT), used for detecting gastrointestinal bleeding associated with disorders such as colorectal cancer, polyps and colitis.

The company said that the new OC-Sensor Diana system measures 280 FIT samples per hour and ensures that quality data is consistently collected. In addition, its compact design (24.8″ by 22″ by 22″ and 133 lbs) is suitable for workstation set-up.

The FIT system screening method is said to provide increased sensitivity and specificity over traditional screening methods. Indicated for use in routine physical examinations, the test measures the presence of human hemoglobin in a patient’s stool. The results assist physicians in recommending patients to colonoscopy, leading to the detection and treatment of colorectal cancer at an earlier stage.

Personal use iFOBT packs allow the patient to collect a sample and return it to the lab for quick results. The company said that iFOBT requires no dietary or medicinal restrictions and only a single sample collection, making it easier and comfortable for use.

Drew Cervasio, president of Polymedco, said: “If detected early, colorectal cancer deaths are preventable. We have seen increased compliance from patients, physicians and laboratory professionals using FIT and less false positive test results than other methodologies. This feeds more of the right patients to colonoscopy. Early detection of colorectal cancer leads to better patient care and improved survival rates, and less invasive and less expensive treatments.

“Catching colorectal cancer early reduces the cost of the overall management of disease to our healthcare system. In this regard, Polymedco is truly changing the outcome of colorectal cancer.”