Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies:
- Tomophase OCTIS wins 510(k) for tomography system
Tomophase Corp., developer of the non-invasive Optical Coherence Tomography Imaging System (OCTIS) and other devices, announced that it has received FDA 510(k) clearance to market OCTIS. OCTIS is comprised of a single-use disposable optical catheter and imaging console. Initially OCTIS will be deployed for tissue imaging of airways and lungs, followed by diagnostic and therapeutic applications.
- CE Mark announced for ArthroCare’s WoundWand debridement device
ArthroCare Corp. (NSDQ:ARTC), a minimally invasive surgical products developer, announced Dec. 9 that its WoundWand debridement device received CE (Conformité Européenne) Mark approval and is available for distribution in Europe. Using ArthroCare’s patented Coblation technology, the WoundWand enables necrotic tissue to be removed from a wound in a precise and controlled manner. The WoundWand is intended for wound debridement in acute and chronic wounds and wound cleansing by removal of necrotic tissue.
- Neoprobe granted Pre-IND meeting with FDA to review RIGS technology
Neoprobe Corp. (OTC:NEOP), a developer of oncology surgical and diagnostic products, announced Dec. 9 that it has requested and been granted a Type B pre-IND meeting with the Food & Drug Administration regarding its RIGS technology Biologic License Application (BLA). The pre-IND meeting request is another step in Neoprobe’s efforts to develop and commercialize the RIGS technology designed to enhance the surgical treatment of patients with solid tumor cancers.
- Hutchinson Technology wins CE Mark approval for InSpectra StO2 Spot Check
Hutchinson Technology Inc. (NSDQ:HTCH) announced CE Mark and the market launch of the InSpectra StO2 Spot Check for use as a noninvasive tool to rapidly assess the tissue oxygenation of patients in circulatory distress. The company also has filed for marketing clearance of the product in the United States under the Food & Drug Administration’s 510(k) process.
- SANUWAVE Health submits to FDA first module of PMA application for dermaPACE for the treatment of diabetic foot ulcers
SANUWAVE Health Inc. (OTC:SNWV), an emerging medical technology company focused on regenerative medicine, reported its submission to the Food & Drug Administration of the first of three modules of the Premarket Approval application for the Company’s dermaPACE device for the treatment of diabetic foot ulcers.
- Ellipse Technologies announces CE Mark approval of PRECICETM remote-control leg limb lengthening device
Ellipse Technologies Inc. announced that it has received CE Mark approval for the company’s PRECICETM limb lengthening device. Limb Lengthening procedures are used to treat a number of medical conditions, including shortened legs due to congenital abnormalities, major fractures of one of the legs and shortened leg bones due to other medical diseases, such as cancer.
- Prodesse ProAdeno+ assay cleared by FDA
Gen-Probe Inc. (NSDQ:GPRO) announced that the Food & Drug Administration granted 510(k) clearance for the Prodesse ProAdeno+ assay, a multiplex real-time polymerase chain reaction in vitro diagnostic test for the qualitative detection of human adenovirus.
- Mederi Therapeutics Announces Receipt of CE Mark for its Second Generation Secca and Stretta systems
Mederi Therapeutics Inc. announced that it has received a CE Mark authorizing the European distribution and use of Mederi’s second generation of the Stretta and Secca Systems. The Stretta System is for treatment of gastric reflux disease, commonly known as GERD, and the Secca System is for treatment of bowel control disorder, or BCD. These latest systems include a streamlined user interface, improvements in ease of use, and are smaller, lighter, and more portable.
- Valeritas Receives FDA 510(k) clearance for the V-Go disposable insulin delivery device
Valeritas Inc., a medical technology company committed to the development and commercialization of innovative drug delivery solutions, announced Dec. 8 that the Food & Drug Administration cleared the company’s V-Go Disposable Insulin Delivery Device for the continuous subcutaneous delivery of insulin in preset basal rates and with on-demand bolus dosing for adult patients requiring insulin. V-Go devices will be available in a preset basal rate to deliver 20, 30 or 40 Units of insulin in one 24-hour period (0.83 U/hr, 1.25U/hr or 1.67U/hr respectively) and on-demand bolus dosing in 2 Unit increments (up to 36 Units per one 24-hour time period).
- Orthovita receives FDA clearance for Vitoss Bioactive Foam-2X bone graft substitute
Orthovita Inc. (NSDQ:VITA), an orthobiologics and biosurgery company, announced that it received 510(k) clearance from the Food & Drug Administration to market Vitoss Bioactive Foam-2X Bone Graft Substitute for use as a non-structural bone void filler for use in the spine, pelvis and extremities. Orthovita expects to launch the newest addition to its bone graft substitute product line by late February or early March of 2011.
- Cytomedix receives ISO 13485 and Canadian Medical Device certifications
Cytomedix Inc. (NYSE:GTF) announced Dec. 7 that it has received certification for the ISO 13485 Quality Management Standard for Medical Devices as well as Canadian Medical Device Certification for its Gaithersburg facility. The announcement certifies Cytomedix as a provider of devices for the medical industry and allows the company to operate commercially in Europe and in Canada.