Privately held Carticept Medical won FDA clearance for the next generation of its Navigator delivery system, which the company touts as the 1st and only computer-controlled injections system on the U.S. market.
Carticept Medical closed a $10 million financing led by existing investors Domain Associates, New Enterprise Associates and SonoSite Inc.
The Alpharetta, Ga.-based company said it will use the proceeds to fund the commercial launch of its Navigator computer-controlled drug delivery system. The device uses ultrasound guidance to deliver medications for joint pain.
GE Healthcare, a unit of General Electric Company (NYSE: GE) landed FDA 510(k) clearance for its SenoBright contrast enhanced spectral mammography for breast cancer diagnosis.
Launched in 2010, the SenoBright system is already used in France, Spain, Italy, Belgium, Germany, Austria and Japan.
The FDA approved a surgical gel designed to temporarily stop blood flow during procedures.
The water-soluble, low-viscosity gel designed by Woburn, Mass.-based Pluromed forms a plug at body temperature to temporarily stent blood vessels without damaging them.
Carticept Medical™ Receives FDA Clearance for Automated Injection System with Integrated Ultrasound Guidance
Navigator™ Delivery System automates drug preparation, delivery, record-keeping and allows physicians to pinpoint needle placement
ALPHARETTA, Ga.–(BUSINESS WIRE)–Carticept Medical, Inc., a developer of innovative products for the treatment of cartilage injuries and osteoarthritis, today announced that it has received 510(k) clearance from the Food and Drug Administration to market its Navigator™ Delivery System (Navigator DS) in the United States. The Navigator DS is a computer-controlled drug delivery system with integrated ultrasound guidance designed to increase the efficiency, accuracy and safety of administering pain-relieving medications for joint pain.
Advanced Cell Technology Inc. (OTC:ACTC) successfully dosed the first patients in clinical trials of stem cell implantation for blinding eye diseases, making it only the second company in the U.S. to win FDA permission to study a therapy derived from embryonic stem cells.
ACTC’s two trials involve implantation of retinal pigment epithelial cells derived from embryonic stem cells into patients with Stargardt’s macular dystrophy and dry age-related macular degeneration.