Here’s a roundup of companies announcing clearances and approvals from the FDA and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.
- FDA approves spine sealant from Covidien
Covidien plc (NYSE:COV) announced that its DuraSeal Exact spine sealant has been approved by the FDA (FDA). DuraSeal Exact spine sealant is a new, low-swell formulation of dural sealant designed as an adjunct to suturing to repair the dura during spine surgery. The dura mater, or dura, encompasses the three layers of the meninges surrounding the spinal cord that protect and hold cerebrospinal fluid.
Read more - Hitachi Medical Systems America wins FDA clearance for its SCENARIA CT system
Hitachi Medical Systems America Inc., a provider of diagnostic imaging equipment, announced FDA clearance to market its SCENARIA CT system, the latest in the company’s line of CT products. SCENARIA combines the latest dose saving technologies in a new 64-slice platform that meets today’s need for a CT system that provides both routine and advanced applications with enhanced performance and value.
Read more - Delcath wins CE Mark for Hepatic Chemostat system
Delcath Systems Inc. (NSDQ:DCTH) announced that the Company has been notified of CE Mark approval for its proprietary Hepatic CHEMOSATTM Delivery System. The product has been approved with an indication for the percutaneous intra-arterial administration of a chemotherapeutic agent (melphalan hydrochloride) to the liver.
Read more - Asante receives CE Mark for Pearl insulin pump
Asante Solutions Inc., a medical device company focused on diabetes care, announced it received the CE mark for its Pearl Insulin Pump, the only insulin pump that uses a pre-filled insulin cartridge. The CE mark is a European proof of conformity that certifies the product meets EU safety, health and environmental requirements. Asante has begun discussions with potential distribution partners in Europe.
Read more - ARTAS receives FDA clearance for hair loss treatment
Restoration Robotics Inc. a privately-held medical device company, announced that its revolutionary technology, the ARTAS System, has received 510K clearance from the FDA for harvesting hair follicles from the scalp in men diagnosed with androgenetic alopecia (male pattern hair loss) with black or brown straight hair.
Read more - St. Jude Medical wins approval for ShockGuard technology
St. Jude Medical Inc. (NYSE:STJ), a global medical device company, announced that it has received FDA and European CE mark approval of its ShockGuard technology. The technology, which can be used with new and existing Unify cardiac resynchronization therapy defibrillators (CRT-Ds) and Fortify implantable cardioverter defibrillators (ICDs), is designed to reduce inappropriate and unnecessary shocks for patients with these devices.
Read more - GE Healthcare receives FDA clearance of GEM suite for MRI
GE Healthcare announced FDA clearance of the GEM Suite (Geometry Embracing Method) of surface coils designed for use with the Optima* MR450w 1.5T wide bore magnetic resonance imaging system, offering excellent patient comfort without clinical compromise. GEM Suite helps technologists reposition patients less often and cover more anatomy; provides radiologists more clinical options; and can give administrators more efficiency through higher throughput and system utilization.
Read more - ThermoGenesis announces registration of Res-Q in India
ThermoGenesis Corp. (NSDQ:KOOL), a supplier of innovative products and services that process and store adult stem cells, said that its Res-Q60 BMC System (Res-Q) has been registered by the Central Drugs Standard Control Organization of India (CDSCO), allowing its commercial sale in the country. Res-Q is a point of care system used for the preparation of cell concentrates, including stem cells from bone marrow aspirate.
Read more - XDx announces that AlloMap wins CE Mark
XDx Inc., a molecular diagnostics company focused on developing and commercializing innovative, noninvasive gene expression tests to monitor immune-mediated conditions, announced that its AlloMap Molecular Expression Test has been CE marked in the European Union (EU) under the In Vitro Diagnostics Directive.
Read more - Medyssey Spine wins Clearance for LP Cage
Medyssey Co., Ltd., the parent company of Medyssey Spine, a spinal implant manufacturer focused on commercializing products for the surgical treatment of spine disorders, announced that the Company has received 510(k) clearance from the FDA for its LP Cage indicated for use in skeletally mature patients with Degenerative Disc Disease at one or two contiguous levels from L2-S1 from a posterior approach for lumbar interbody fusion. The product is currently in limited, controlled release and is targeted for full commercial launch by Q4 2011.
Read more - Devon wins clearance for ArterioFlow
Devon Medical Products, a manufacturer and distributor of creative, safe, and cost-effective medical devices, announced it received FDA 510(k) clearance to market its ArterioFlow 7500 arterial pump that treats diabetic foot ulcers, peripheral arterial disease, and other chronic disorders of the lower extremities caused by reduced blood supply or ischemia.
Read more - Integra LifeSciences wins slearance for new indication for Accell Evo3
Integra LifeSciences Holdings Corporation (NSDQ:IART) announced that it has received 510(k) clearance from the United States FDA to market Accell Evo3 Demineralized Bone Matrix as a bone void filler product for use in the posterolateral spine.
Read more - Aethlon Medical announces multi-target exosome assay validation
Aethlon Medical Inc. (OTC:AEMD) announced that its wholly owned subsidiary Exosome Sciences Inc. (ESI) has validated the ability of its Enzyme Linked Lectin Specific Assay (ELLSA) to identify the presence of exosomes underlying the human immunodeficiency virus (HIV), tuberculosis (TB), and various forms of cancer, including ovarian, melanoma, breast, lymphoma, and colorectal.
Read more - SurgiVision MRI-compatible SmartFlow cannula receives FDA clearance
SurgiVision Inc., a leader in interventional MRI-guided systems, announced at the American Association of Neurological Surgeons (AANS) annual meeting that its SmartFlow neuro ventricular cannula has received FDA clearance.
Read more - Cepheid wins clearance for Xpert Clostridium difficile/Epi
Cepheid (NSDQ:CPHD) announced that it has received clearance from the FDA to market its Xpert C. difficile/Epi test. Cepheid’s first Xpert C. difficile test has been available in the United States since July 2009. The test’s unique combination of high sensitivity and rapid turnaround time has quickly established Xpert C. difficile as the molecular market leader. Building on the success of Xpert C. difficile, which detects the bacterium that causes C. difficile infection (CDI), Xpert C. difficile/Epi additionally and simultaneously identifies the epidemic strain of C. difficile, also known as 027, NAP1 or BI.
Read more - FDA clears single-use antibacterial surgical respirator
The FDA cleared the SpectraShield 9500 N95 surgical respirator, a device that kills 99.99 percent of three different kinds of bacteria when exposed to its outer surface.
Read more - Integra receives FDA clearances for three spinal fixation devices
Integra LifeSciences Holdings Corporation (NSDQ:IART) announced that it has received 510k clearance from the United States FDA for three new spinal intervertebral body fusion devices (IBD), continuing to build its momentum in the spine market.
Read more - GenesisPlus receives FDA clearance for Onychomycosis
Cutera Inc. (NSDQ:CUTR), a worldwide provider of laser and light-based aesthetic systems for practitioners worldwide, announced FDA 510(k) clearance for its GenesisPlus. The complete list of the indications for use can be found in the FDA 510(k) clearance number (K) 103626.
Read more - superDimension receives FDA 510(k) clearance for marker delivery kit
superDimension Ltd., a privately-owned company that develops minimally invasive interventional pulmonology devices, announced it has received FDA 510(k) clearance for the superDimension marker delivery kit. The kit is designed for use with the Company’s Electromagnetic Navigational Bronchoscopy (ENB) system, which has treated a total of 20,000 total patients since commercial launch.
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