• American Bio Medica (Kinderhook, New York) said that the FDA has granted CLIA waived status to the company's Rapid TOX point-of-collection drug test product line. The waiver applies to all 14 drugs that the company currently tests for in addition to two different cut-off levels for its opiate and cocaine tests. CLIA-waived tests are the most widely used tests in the clinical market, including both hospitals and physicians, and are in demand for occupational health and criminal justice applications. American Bio Medica makes diagnostic test kits, including point-of-collection tests for drugs of abuse.

• Cutera (Brisbane, California) reported regulatory clearance and the commencement of shipments of its newest product, Pearl Fractional. Pearl Fractional, with its 2790 nm wavelength, is Cutera's solution for the fractional ablative market. "Pearl Fractional targets the deep dermis to treat the signs of aging," said Kevin Connors, president/CEO of Cutera. "Our team recognized the limitations of CO2 fractional lasers and designed our product to deliver a better experience to patients and physicians. Pearl Fractional produces a confined thermal zone in the dermis with the goal of reducing post-operative downtime, which we believe will result in greater patient interest." Cutera makes laser and other light-based aesthetic systems.

• TomoTherapy (Madison, Wisconsin) said it has received FDA clearance for its TomoDirect radiation therapy technology. TomoDirect is a discrete-angle, sliding-beam delivery mode for the Hi Art treatment system. With this capability, clinicians gain a complement to helical TomoTherapy, one that enables fast treatment planning and delivery, while broadening the spectrum of patients that can be optimally treated with what the company terms the industry's most advanced platform for cancer care. TomoDirect was developed as a complement to helical TomoTherapy, with both modes using the same binary multi-leaf collimator and CT-style gantry technology, and sharing a simple, consistent treatment planning and delivery process. The choice of which modality to use for a given case will depend on the nature of the tumor volume and surrounding organs at risk. TomoTherapy makes radiation therapy products.