• GenPrime (Spokane, Washington) has initiated multi-site clinical trials of its bacterial contamination test for platelets. The test is a rapid QC device for detecting the presence of aerobic and anaerobic bacteria commonly found in contaminated platelets. Based on a lateral flow technology platform, GenPrime’s bacterial contamination test for platelets is designed to detect all 15 organisms known to contaminate platelets. Additionally GenPrime has developed an automated test reader and software for objective result analysis and data collection. GenPrime makes rapid microbial analysis technologies.

• Medical Decisions Network (Charlottesville, Virginia) reported FDA clearance of its MDN-CGS IV insulin dosing software. The MDN-CGS software is used by hospital nurses to quickly and accurately calculate the dosage of intravenous insulin administered to patients with elevated levels of blood glucose, the simple form of sugar the body converts to energy for survival. The MDN CGS is a networked application, accessible from any computer on a hospital’s network. This means that clinicians can continue a patient’s infusion progress even when the patient is moved to a new unit. Medical decisions network makes connectivity solutions for clinical laboratory point-of-care data management.

• Memry (Bethel, Connecticut) reported official launch of its expanded Nitinol Hybrid Tubing product line. This expanded tubing platform, with sizes ranges up to 10 mm is the largest diameter and thinnest wall material offered in Memry’s tubing portfolio, according to the company. Using a manufacturing process employing a double-core technique, Memry says it is able to offer thinner walls and tighter wall thickness control for manufacturing hybrid tubing. Memry makes nitinol and polymer components to the medical device industry.

• Nanosphere (Northbrook, Illinois) reported FDA clearance for the Verigene F5/F2/MTHFR nucleic acid test, which detects disease-associated gene mutations that can contribute to blood coagulation disorders and difficulties metabolizing folate (vitamin B-12). The Verigene is a test for the identification of mutations in three specific genes that together can increase an individual’s risk for dangerous blood clots and their leading complication, stroke. Nanosphere is a nanotechnology-based molecular diagnostics company.

• Pinyons Medical Technology (Park City, Utah) said it received FDA clearance to market the PowrSyringe Aspirator. The PowrSyringe is a disposable hand-held medical device that incorporates ergonomic and mechanical advantages for fluid aspiration during a variety of medical procedures. The PowrSyringe eliminates the need for two hands to perform aspiration. The Aspirator’s design includes handles connected to an integrated syringe barrel and plunger that pull the plunger back when the handles are squeezed.

• SonoSite (Bothell, Washington) introduced the S-ICU visualization tool, the first ultrasound device custom-designed for the intensive care physician. With the S-ICU tool, intensivists get the image quality of SonoSite’s M-Turbo system with the user interface, software and controls specialized to address the point-of-care exams and procedures commonly performed in a hospital ICU. The system boots from a cold start in seconds and the optimal image can be acquired immediately with just two controls. Weighing 8.35 pounds, the S-ICU tool can be easily carried, mounted on an IV pole, or fixed on a wall or ceiling for zero footprint, and survive being dropped from three feet onto a hard surface. Its sealed interface can be easily wiped down with disinfectant, which is crucial for reducing infection risk in an ICU. SonoSite makes hand-carried ultrasound products.

• TEI Biosciences (Boston) reported the launch of its SurgiMend collagen matrix for soft tissue reconstruction product. TEI has received FDA clearance to market SurgiMend for expanded use in plastic and reconstructive surgery, including breast reconstruction, and for tendon augmentation, in addition to the previously cleared hernia repair and muscle flap reinforcement indications. SurgiMend is an acellular, terminally sterilized biologic matrix derived from the dermis of fetal calves, one of the purest sources of collagen available. It is intrinsically strong yet soft and pliable when hydrated, and handles like natural tissue; it readily conforms to the surgical site and is easily sutured. TEI Biosciences specializes in regenerative medicine to make biologic products for a broad spectrum of soft tissue repair and reinforcement applications.

• Terumo Interventional Systems (Somerset, New Jersey) reported the launch of the TR Band, a radial artery compression device designed to safely and comfortably stop bleeding after transradial procedures. The TR Band does so with its two separate inflatable balloons. A large balloon compresses the entire puncture site, and a small balloon gives it an angled direction for point compression. Terumo makes a full line of guidewires, catheters, introducer sheaths, guiding sheaths and embolization products for use in a multitude of different interventional procedures.