• Allergan (Irvine, California) reported FDA approval of label extensions for Juvederm ultra and Juvederm ultra plus based on new clinical data demonstrating that the effects of both products may last for up to one year, which is longer than reported in clinical studies that supported FDA approval of other hyaluronic acid (HA) dermal fillers. Juvederm ultra and ultra plus are HA dermal fillers made with Hylacross technology. Allergan is the maker of Botox cosmetic (Botulinum toxin type A).

• Aspect Medical Systems (Norwood, Massachusetts) has received FDA clearance for the BIS View Monitoring system, the company’s newest stand-alone monitor. The monitor offers customers a compact design and simplified operation for lower acuity clinical environments with limited room for monitoring equipment. According to the new indication for use statement cleared by the FDA, Bispectral Index (BIS) monitoring may be used as an aid in monitoring the effects of certain anesthetic agents and may be associated with a reduction in primary anesthetic use and a reduction in emergence and recovery time. Use of BIS monitoring to help guide anesthetic administration may also be associated with the reduction of incidence of awareness with recall in adults during general anesthesia and sedation. Using a sensor placed on the patient’s forehead, BIS monitoring translates information from the electroencephalogram into a single number that represents each patient’s level of consciousness. This number — the BIS value — ranges from 100 (indicating an awake patient) to zero (indicating the absence of brain activity). Using the BIS value to guide administration of anesthetic medication, clinicians can make informed decisions for optimal anesthesia or sedation. Aspect Medical Systems specializes in brain monitoring technology.

• CapsuleTech (Portland, Oregon) reported new additions to the list of bedside medical devices supported by DataCaptor Connectivity Suite, the leading independent medical device connectivity solution. Healthcare organizations that have deployed DataCaptor connectivity suite in their department or enterprise can integrate patient vital signs and other data from virtually any medical device. Among the newest devices supported is the Danmeter cerebral state monitor, which produces spontaneous EEG monitoring of the level of consciousness or depth of anesthesia during anesthetic procedures at the point-of-care. CapsuleTech provides solutions for medical device data integration. Danmeter makes portable medical devices for pain, rehabilitation, and monitoring.

• Globus Medical (Audubon, Pennsylvania) reported the introduction of the Citadel anterior lumbar plating system. The system has been implanted successfully in approximately 40 surgeries to date. Citadel’s product development engine squeezes inefficiency out of the development cycle by using parallel processes to anticipate, identify and correct potential issues early. The Citadel consists of plates of various lengths to be used with variable or fixed bone screws for fixation to the anterior or anterolateral aspect of the vertebral bodies of the lumbar and lumbosacral spine. Globus is a privately-held spinal implant manufacturer.

• K2M (Leesburg, Virginia) reported the launch of its new Range spinal system. This system combines the newest versions of the Mesa and Denali spinal systems and includes new instruments designed to enhance the surgeon’s ability to address complex spinal pathologies such as scoliosis, which is a deforming or abnormal curvature of the spine. The Range is designed to provide surgeons with the ability to make an array of inter-operative decisions for spinal correction based on both the patient’s pathology and the instruments and implants the system offers. Denali set screw based system that enables surgeons to address both upper and lower back surgeries. K2M is a spinal device company.

• Thermage (Hayward, California) reported the introduction of Lips by Thermage, a non-invasive procedure to help smooth and tighten skin for fuller, more defined looking lips and decreased fine lines. The procedure is the latest in a suite of procedures under the Body by Thermage umbrella and is a non-invasive alternative to the many surgical and injectable options available on the market today. The procedure uses a 1.5 cm² ThermaTip ST treatment tip, which is specifically designed to treat smaller areas, such as the skin above the upper lip. During clinical evaluations, patients found their lips had a fuller and more defined appearance, fine lines and wrinkles were diminished, and the skin above their lips was smoother and softer. Thermage makes non-invasive procedures to tighten and contour skin.