• Candela (Wayland, Massachusetts) said that it received an additional FDA clearance for the Serenity device using pneumatic skin flattening (PSF) technology. This clearance enables the use of the Serenity device for the reduction of pain during all laser and intense pulse light (IPL) treatments. According to Millennium Research, the worldwide installed base of laser and IPLs is estimated to be 70,000 worldwide. “Patients often discontinue their aesthetic laser treatments because of pain. The PSF technology relies on the Gate theory for pain reduction which inhibits the transmission of pain signals to the brain, making treatments more tolerable and thus, improving outcomes,” said Nicole Shugrue, senior product marketing manager at Candela. “The expanded product claim will allow practitioners to differentiate their aesthetic practice and improve patient retention by offering this device as an adjunct to their entire laser and intense pulse light aesthetic treatment platform.” Candela makes products to treat selected cosmetic and medical conditions using lasers, aesthetic laser systems, and other advanced technologies.

• Celsion (Columbia, Maryland) said that it has reached an agreement with investigators at Duke University (Durham, North Carolina) to supplement the Phase I dose escalation study for recurrent breast cancer at the chest wall, currently being performed under an investigator IND at Duke, through the filing of a company IND using the same clinical protocol. Celsion plans to add up to three additional sites in the study. The clinical activity observed in the first evaluable patients enrolled in the study suggests that the combination of ThermoDox and localized hyperthermia may have potential for clinically important anti-tumor activity on the chest wall. ThermoDox is Celsion’s heat-sensitive liposomal encapsulation of doxorubicin, an anti-cancer drug used in the treatment of various cancers including breast cancer. Localized mild hyperthermia (40-42°C) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor, according to the company. Celsion makes oncology drugs including tumor-targeting treatments using focused heat energy in combination with heat activated drug delivery systems.

• Cholestech (Hayward, California) reported the launch of its new Lipid Profile ALT test cassette. This new, CLIA waived cassette combines a lipid profile with ALT (alanine aminotransferase), the most common marker for liver damage. Physicians now have one convenient test to obtain laboratory-accurate results for lipids and ALT in just five minutes, making statin management more efficient. Physicians in the U.S. can monitor statin patients’ lipid results and liver enzymes on the Cholestech LDX in the physician office lab with a single fingerstick. Clinicians confirm that face-to-face consultation makes a stronger impact on the patient, thus improving adherence to a therapy plan. This teachable moment is facilitated by physician office lab testing, as opposed to the delays associated with sending samples to off-site labs. Test results are available in just five minutes. Cholestech is a provider of alternate site health management solutions for chronic diseases.

• Vital Images (Minneapolis, Minnesota) said it has released its next generation enterprise-wide advanced visualization and analysis product solutions with the release of Vitrea 4.0 and ViTALConnect 4.1. This package offers advanced visualization and analysis capabilities via workstation clients, remote clients and Web-based clients. In addition to the new version enhancements, the company also released ViTAL EP, a new electrophysiology planning application to augment its cardiovascular suite of products and Medicsight’s ColonCAD for its InnerviewGI virtual colonoscopy application. Enhancements to the company’s Vitrea 4.0 workstation-client release include cardiovascular workflow enhancements such as automatic segmentation and probing of the coronary tree, easier vessel management and labeling, easy centerline editing and comprehensive reporting with automatic population of findings. Neurovascular improvements include motion correction and simultaneous multi-slice computation for true 4-D perfusion for stroke patients. This release also includes improved colon enhancements such as fly-through capabilities, polyp probe and automatic registration of prone and supine, among other significant usability improvements including computer aided detection designed to identify suspicious regions in the colon. Vital Images makes visualization and analysis solutions.

No Comments