The U.S. Food and Drug Administration has granted 510(k) clearance to Ivera Medical Corporation, allowing it to market its Curos™ Port Protector. The product decontaminates needle-less intravenous access ports, preventing touch and airborne contamination. Designed to lessen patients’ exposure to the risks of bloodstream infections acquired from hospitals, the Curos Port Protector facilitates infection control. Such infections lengthen a patient’s stay in hospital and can be dangerous too. Thus, the device can be really useful in improving patient care through promotion among healthcare professionals.

SPOC, the students of Stevens Institute of Technology and Dr. Norman Marcus, pain-management expert, have jointly developed a handheld bio medical device for pain management. The product has received the 510K clearance from the FDA for manufacturing and marketing as a clinical device. The product started its life as Stevens’ undergraduate Senior Design Team project and has also given birth to SPOC Inc, based at Stamford, Conn.

Medtronic Inc. has received clearance from the FDA for its OneTouch UltraLink Meter to wirelessly transmit glucose readings directly to insulin pumps and a continuous glucose monitoring system. This makes bolus dosing more accurate and easier for patients compared with the manual entry of blood glucose readings, the company said. Medtronic plans a staged launch of the meter.

OMRIX Biopharmaceuticals has received FDA approval to start the Phase II clinical trial for its Fibrin Patch product candidate in the U.S. The patch is used for patients suffering from mild to moderate bleeding. According to the company, the trial is likely to start in the second quarter of 2008.

The FDA has issued a warning letter to E Med Future, which manufactures NeedleZap, a needle disintegration device. The FDA stated that the company has failed to set up and maintain a quality system. Over the past two years, the company has not implemented any quality procedures, including complaint procedures, quality audits and corrective and preventive action procedures, the letter said.