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Carticept Medical Inc.

FDA OKs Carticept’s next-gen computer-controlled injection system

April 16, 2013 By Arezu Sarvestani Leave a Comment

Carticept Logo

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.

Filed Under: 510(k), Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Carticept Medical Inc.

Carticept closes $10M round from SonoSite, others | Funding Roundup

January 19, 2012 By MassDevice staff Leave a Comment

Carticept Medical

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.

Filed Under: Drug-Device Combinations, Funding Roundup, News Well Tagged With: Aribex, Bioconnect Systems, Cadence Biomedical, Cambridge Heart Inc., Canaan Partners, Cardio3 Biosciences Inc., Carticept Medical Inc., Domain Associates, Fujifilm, GE Healthcare, IBA, NeuroLogica Corp., New Enterprise Associates, Practice Fusion, SK Capital, SPR Therapeutics LLC, uptakemedical, Urologix Inc.

Breast Cancer: GE Healthcare lands FDA clearance for SenoBright system | Regulatory Roundup

October 14, 2011 By MassDevice staff Leave a Comment

GE Healthcare

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.

Filed Under: Mammography, News Well Tagged With: Breast Cancer, Candelis Inc., Carticept Medical Inc., Eye on the FDA, Freedom Meditech, GE Healthcare, ISTO Technologies, PLC Medical Systems Inc., Regulatory Roundup

FDA approves surgical gel to stop blood flow | Regulatory Roundup

October 5, 2011 By MassDevice staff Leave a Comment

FDA

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.

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: American Medical Assn., Carticept Medical Inc., Cutera Inc., Eye on the FDA, Guided Therapeutics Inc., iCad Inc., JenaValve, Pluromed Inc., Regulatory Roundup, Smiths Medical

Carticept Medical receives FDA Clearance for automated injection System with Integrated Ultrasound Guidance

October 5, 2011 By MassDevice

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.

Filed Under: Blog Tagged With: Carticept Medical Inc., Press Release

Embryonic stem cells debut in eye treatment in Advanced Cell Tech’s first human trials | Regulatory Roundup

July 21, 2011 By MassDevice staff Leave a Comment

ACTC

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.

Filed Under: News Well, Regenerative Medicine, Research & Development, Stem Cells Tagged With: Advanced Cell Technology Inc., Alphatec, BG Medicine Inc., Biosense Webster, Carticept Medical Inc., Luminex Corp.

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