• Biofield (Atlanta) said the FDA has conducted a review of the company's request for reclassification of the Biofield Breast Proliferation Rate Detection System that is intended as an adjunct to support other modalities such as mammography, clinical breast exam, sonography and MRI used in breast cancer diagnosis. The company said the FDA determined that its device does not meet the criteria for Class I (General Controls) or Class II (Special Controls) classification and therefore falls into Class III, for which 510(k) clearance does not apply. Approval must instead be sought through a premarket approval (PMA) allication. David Long Jr., MD, PhD, chairman and CEO, said the company intends to meet shortly with the FDA to discuss regulatory pathways and data requirements. "The company plans to cooperate with the FDA in this process of moving forward under the format of a PMA," he said.

• CSMG Technologies (Corpus Christi, Texas) said that it has received notice of allowance from the U.S. Patent and Trademark Office for "Bonding of soft biological tissues by passing high frequency electric current there-through," U.S. (divisional) patent No. 09,022,869, for its live-biological-tissue bonding/welding platform technology. The tissue-bonding device bonds through radio frequency fusion and reconnects living soft biological tissue without the use of foreign matters or conventional wound-closing devices. The technology leaves little or no scar visible to the naked eye after a few months, the company said. Unlike other tissue coagulation methods, CSMG said its technology bonds and reconnects incised tissue and avoids charring, searing and necrosis using a patented low-heat delivery method while providing a leak-proof, smokeless and bloodless reconnection.

• Curis (Cambridge, Massachusetts), a therapeutic drug development company, said it was issued U.S. patent No. 6,861,404, titled "Novel therapies for chronic renal failure." The claims of this patent recite methods for improving kidney function by activation of the bone morphogenetic protein (BMP) pathway through the administration of BMP-7 or a related protein. The patent also specifies a method for delaying the need for, or reducing the frequency of, chronic dialysis treatment associated with end-stage renal disease.

• Dade Behring Holdings (Deerfield, Illinois) said its NT-proBNP (N-terminal pro brain natriuretic peptide) test has received FDA clearance for use on its Stratus CS Acute Care Diagnostics System. The assay has been cleared to aid in the diagnosis of heart failure, including assessment of heart failure severity in patients diagnosed with congestive heart failure, and risk stratification of patients with acute coronary syndrome and heart failure. The test will begin shipping later this month. In December 2004, clearance was received for the use of NT-proBNP in the assessment of heart failure severity and risk stratification on the company's Dimension instruments with Heterogeneous Immu-noassay Module.

• Entelos (Foster City, California), which is focused on biosimulation technologies for pharmaceutical research and development, reported that the U.S. Patent and Trademark Office has issued U.S. patent No. 6,862,561, titled "Method and apparatus for computer modeling a joint." The patent provides broad coverage for methods of modeling biological processes in the joint, including cartilage metabolism and tissue inflammation. Other claims in the patent cover the software used to implement these and related methods.