Mauna Kea Technologies SAS, of Paris, said it received an FDA clearance that covers Confocal mini-probes indicated for use in urological and minimally invasive surgical applications with the near-infrared Cellvizio platform.
The FDA approved Probuphine, a buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine is marketed by San Francisco-based Titan Pharmaceuticals Inc. and Braeburn Pharmaceuticals, of Princeton, N.J. Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months to patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program.
Valeritas Holdings Inc., of Bridgewater, N.J., reported the positive results of five retrospective analyses of the clinical and cost benefits of the company's lead product, the V-Go disposable insulin delivery device. Valeritas said the studies showed that when using or switching to V-Go, patients with diabetes experienced improved glycemic control, a reduction in A1C, and required less insulin than the comparison treatments.