• CSL Behring (King of Prussia, Pennsylvania) said it has submitted a biologics license application to the FDA requesting approval to market its human fibrinogen concentrate in the U.S. for the treatment of congenital fibrinogen deficiency, a rare bleeding disorder resulting from deficiency of fibrinogen. Fibrinogen, also called Factor I, is a protein needed to form a blood clot. Fibrinogen levels in plasma determine the potential clotting ability and activity in the body. Rarely, a person may have a normal quantity of fibrinogen, but the fibrinogen does not function as needed. Symptoms of a fibrinogen deficiency include excessive bleeding following injury, bruises, bleeding of the umbilical cord at birth and from the site of the umbilical stump in a newborn baby, and bone, joint or tissue hemorrhage. CSL Behring specializes in plasma protein biotherapeutics.

• K2M (Leesburg, Virginia) reported the launch of its RANGE rigid rod (R2 rod). The cobalt chrome alloy rod is an implant addition to the RANGE spinal system. This rod features flexural rigidity properties comparable to 5.5 mm diameter stainless steel and 6.35 mm titanium alloy. Since cobalt chrome is compatible with titanium, surgeons may have more intra-operative flexibility with various rod offerings in one system. K2M is a spinal device company that specializes in the treatment of complex spinal pathologies and procedures.

• Primex Wireless (Lake Geneva, Wisconsin) debuted its new product line — the world's first 802.11 wireless clock — at the American Society for Healthcare Engineering. The new product line, the Synchronous Network System (SNS) is designed to fully leverage a facility's IT network by synchronizing clocks and timers via 802.11 wireless or Ethernet. The entire system is managed from a web browser and includes automated system monitoring establishing a new standard in time systems. SNS uses network time protocol to synchronize clocks on the network and also incorporates two-way communication with each clock on the network. No matter where the clocks are located physically or on the network, SNS allows the flexibility to check them all at once, or SNS will simply provide email notification when the clocks need attention. Primex Wireless makes wireless synchronized timekeeping systems.

• ThermoGenesis (Rancho Cordova, California) reported receiving FDA authorization to begin marketing its MarrowXpress device for use in a clinical laboratory setting or intraoperatively for preparation of a cell concentrate from bone marrow. Bone marrow derived stem cells are the dominant source of stem cells studied in regenerative medicine clinical trials for treating several large patient population diseases and injuries including blood disorders, ischemic heart diseases, peripheral artery diseases, and diabetes. ThermoGenesis makes products and offers services for processing and storing adult stem cells.

• VendorClear (Eden Prairie, Minnesota) reported the introduction of the VendorCam and VendorReserve. VendorCam is a real-time, two-way, audio-visual communication system for healthcare facilities and vendor representatives. VendorCam's HIPAA-compliant technology now makes it possible to do everything from virtually observing and supporting procedures, to training clinicians and new sales reps and completing physician to physician proctorships. VendorReserve is a reservations management system for healthcare facilities. VendorReserve provides a transparent reservations solution that allows physicians offices, clinics and hospitals to better control access by allowing them to see who, what, when, and where vendors are accessing their facility.

• Wound Management Technologies (Fort Worth, Texas) reported the filing of a new 510(k) on a new wound management product using its hydrolyzed collagen technology. The new product will combine the hydrolyzed collagen with the healing properties of PSGAG (polysulfated glycosaminoglycan) and will initially be available in gel form. Hydrolyzed collagen with PSGAG wound gel is an absorbent hydrolyzed collagen for the management of exudative wounds. Wound Care Innovations' wound care hydrolyzed collagen product, CellerateRx, is FDA cleared for acute and chronic wounds which include but are not limited to pressure ulcers (stage I-IV), traumatic wounds, diabetic ulcers, surgical wounds, venous stasis ulcers, ulcers due to arterial insufficiency, superficial wounds, and 1st and 2nd degree burns.