• Kinetic Concepts (KCI; San Antonio) reported the acute phase results of a randomized, controlled, clinical trial on the use of its V.A.C. therapy in the treatment of complex diabetic foot ulcers where the use of V.A.C. therapy resulted in the following benefits: a significant increase in the number of wounds that completely closed; a significant improvement in the time to achieve wound closure; and a significant improvement in the formation of granulation tissue, which is essential for successful wound healing. KCI said that the study findings are important because an estimated 15% of all diabetics will eventually experience a significant wound resulting in amputation. KCI Manufactures advanced wound care technologies and therapeutic surfaces.

• Mentor (Santa Barbara, California) reported FDA approval of an amendment to its MemoryGel silicone gel-filled breast implant post-approval study (PAS) protocol. The PAS protocol amendment addresses patient enrollment. Responding to questions and feedback from a number of institutional review boards and physicians concerning the restriction of patient access to an approved device, the FDA approved Mentor's amendment to the PAS protocol to a voluntary patient enrollment design, allowing those patients who choose not to or cannot participate in Mentor's PAS the opportunity of selecting Mentor's MemoryGel implants for their surgery. Mentor is a supplier of medical products for the global aesthetic market.

• Minrad International (Orchard Park, New York) said it has received approval from FDA to market Sojourn (Sevoflurane) inhalation anesthetic. Minrad International is an interventional pain management company that manufactures real-time image guidance anesthesia and analgesia product lines.

• NeuroLogica (Danvers, Massachusetts) reported launch of its CereTom OTOscan in-office computed tomography scanner optimized for otolaryngology, the OTOscan. The system provides the images of both bone and soft tissue by enabling patient scans directly during office visits and avoiding the need to refer patients to an imaging facility to receive ear, nose and throat diagnostics. The OTOscan is a portable eight-slice CT scanner that acquires 1.25 mm slices per rotation. It is 29 inches long, about 5 feet tall and 4 feet wide, weighing about 750 pounds. The system's battery can be recharged in any standard wall outlet and holds enough power to image four to eight patients. The scanner also includes a mini-PACS system that is ideal for use in the physician's office. NeuroLogica is a neuroscience-based medical imaging company.

• Ohio Medical (Gurnee, Illinois) reported that it is expanding its existing oxygen line with launch of the DurO2 regulation devices, click-style regulators and conservers that pass the ASTM G175-03 ignition and sensitivity tests — recommended by the FDA, but not currently required. Ohio Medical is an ISO 13485-registered and FDA-regulated device manufacturing facility which specializes in suction and oxygen therapy equipment for clinical use.

• Picis (Wakefield, Massachusetts) reported release of CareSuite ED PulseCheck version 3.7, an emergency department information system. ED PulseCheck combines patient tracking, physician and nursing documentation, risk management, charge management and other unique features into a Web-based application. The new version provides improved user interface, medication reconciliation and pay for performance. Picis makes high-acuity care information systems.

• Sanofi-aventis (Bridgewater, New Jersey) reported that the FDA has approved Lantus SoloStar, a prefilled disposable insulin pen for once-daily 24-hour insulin Lantus (insulin glargine) for the treatment of hyperglycemia in people with Type 1 or Type 2 diabetes. SoloStar is a disposable insulin pen that allows patients to administer doses from 1 up to 80 units, in one injection. Lantus SoloStar should be kept in cool storage until first use. Once in use, it can be kept at room temperature, as long as it remains below 77 F and can be used for up to 28 days. Sanofi-aventis specializes in cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines.

• Sensatex (Bethesda, Maryland) reported that it will shortly begin field trials of its SmartShirt system, designed to monitor an individual's heart rate, respiration and movement wirelessly and remotely. The field tests are the final step before the product will be commercially available. The shirt collects physiological signals from the wearer's body which are converted to digital signals using a small personal controller and sent wirelessly to a base station through either Bluetooth or ZigBee wireless technology. Potential applications include first responders, military personnel, people with sleep apnea, homebound elderly, post-operative patients, truckers, patients undergoing physical rehabilitation, patients in rural settings and more. Sensatex makes textile materials and applications.