• Bovie Medical (Melville, New York) said it received FDA clearance to market its SEER tissue resection device intended for initial use in liver oncology surgery. The SEER device uses conductive sintered steel as an electrode for radio frequency (RF) for cutting and coagulation. The process involves delivery of RF current and sterile saline for resection and coagulation in surgical procedures.

• CLRS Technology (Costa Mesa, California) reported the Claro acne-clearing device received FDA marketing clearance for the treatment of mild-to-moderate inflammatory acne. According to the company, Claro is the first hand-held device to use Intense Pulsed Light (IPL) for acne treatment. Claro delivers a series of light pulses in 6 seconds that safely penetrate the skin to eliminate the bacteria that cause acne and reduce inflammation. Clinical studies demonstrate a 94.8% decrease in p. acnes bacteria after just one treatment.

• DePuy Mitek (Raynham, Massachusetts) reported the launch of the Healix BR dual-threaded anchor system, the first suture anchor for arthroscopic rotator cuff repair made with the company's Biocryl Rapide biocomposite material, shown in pre-clinical trials to resorb and promote bone formation within the implant profile. "Biocryl Rapide has become an important technology platform in orthopedics sports medicine," said Ian Lawson, worldwide president, DePuy Mitek. "We will continue to explore its applications with many other products as we stay true to our mission of improving patient quality of life by creating innovative mobility therapies." Healix BR is an extension of the Healix PEEK family of anchors. Both anchors are designed to independently engage cortical and cancellous bone, maximizing pull-out strength and potentially minimizing re-tears. Healix anchors are available in three sizes (4.5 mm, 5.5 mm and 6.5 mm) to address a wide variety of surgical techniques, and may be pre-loaded with Orthocord, the company's high-strength suture.

• Quick-Med Technologies (Gainesville, Florida) said that Albina Mikhaylova, PhD, senior scientist at Quick-Med, presented evidence at the Symposium on Skin and Wound Care that the company's Nimbus antimicrobial technology poses no threat of bacterial resistance. The findings are in contrast to known resistance issues with leading antibiotics that have allowed soaring hospital-acquired infection rates worldwide. The new study examined the propensity of Nimbus antimicrobial barrier material to induce bacterial resistance. The testing of the survivors of each of ten consecutive generations of E. coli exposed to Nimbus, the highly charged, substrate-bonded antimicrobial, revealed no change in bacterial resistance and consistently demonstrated the original high antimicrobial efficacy of the Nimbus-treated substrate. This finding comes at a time when public concern for the risk of serious infections from exposure to such bacteria as methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus is increasing because these highly resistant bacteria are proving to be increasingly refractory to successful therapy.

• Siemens Healthcare (Deerfield, Illinois) said that data from a new study published in the American Cancer Society journal Cancer, supports using the Siemens Serum HER-2/neu test to monitor patients with an aggressive type of metastatic breast cancer. This non-invasive blood test can be used to help monitor the widely-used Herceptin therapy. The Siemens Serum HER-2/neu blood test is intended to quantitatively measure the HER-2/neu protein in serum of women with metastatic breast cancer. The use of the Serum HER-2/neu test is indicated for follow-up and monitoring of patients with metastatic breast cancer whose initial serum HER-2/neu value is greater than 15 ng/mL. HER-2/neu values should be used in conjunction with information available from clinical and other diagnostic procedures in the management of metastatic breast cancer. The clinical use of the serum measurement of HER-2/neu as a prognostic indicator for early recurrence and in the management of patients on immunotherapy regimens has not been fully established.