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Premarket Approval
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84% of Devices Had Not Been Tested on Any Child Before The Approval Was Granted.
Apr 14, 2014A study of 25 high-risk medical devices approved for use on children showed that 84 percent of those devices approved by FDA since 2008 had not been tested on any child under 18 years of age before the approval was granted. Eleven had not ...
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Developing Oncology Companion Diagnostic Test Was Agreed by Amgen and Illumina
Jan 17, 2014Illumina has entered into an agreement with Amgen to develop and commercialize a multigene, NGS-based test as a companion diagnostic for Vectibix (panitumumab), a fully human anti-EGFR monoclonal antibody therapeutic for the treatment of ...
Tags: Amgen, FDA, CE, Illumina Oncology
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Integra Lifesciences Has Announced The Completion of Patient Enrollment
Dec 25, 2013Integra LifeSciences, has announced the completion of patient enrollment in a pivotal clinical trial designed to assess the safety and effectiveness of Integra dermal regeneration template in the treatment of diabetic foot ulcers. Integra ...
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Philips Is Offering Free Replacement of The Devices
Dec 5, 2013A faulty electronic component in some Philips HeartStart automated external defibrillators may prevent the device from delivering a needed shock to a person suffering a cardiac emergency, the FDA recently warned. The Dutch multinational's ...
Tags: Philips Defibrillator, FDA
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FDA Halted The Selling of The 23andMe Saliva Collection Kit
Nov 27, 2013The U.S. Food and Drug Administration halted the selling of the 23andMe Saliva Collection Kit and Personal Genome Service -- a home DNA test. In a letter posted on its website, the FDA alleged 23andMe was being sold without clearance or ...
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Salix Has Approved The Deflux Premarket Approval (PMA) Supplement
Nov 20, 2013US-based Salix Pharmaceuticals has announced that The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has approved the Deflux premarket approval (PMA) supplement, which requested approval of ...
Tags: Salix, Injection Techniques
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Neuropace Has Received FDA Premarket Approval for Its Neuropace RNSSystem
Nov 18, 2013US-based NeuroPace has received the US Food and Drug Administration (FDA) premarket approval for its NeuroPace RNS system, designed to treat partial onset seizures that have not been controlled with two or more antiepileptic medications in ...
Tags: RNS System, NeuroPace
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Novocure Announced FDA Has Approved The Novotal System Through a Pma Supplement
Nov 7, 2013Novocure announced that the US Food and Drug Administration (FDA) has approved the NovoTAL (Transducer Array Layout) system through a premarket approval (PMA) supplement. The NovoTAL System allows certified physicians to use the ...
Tags: Novotal System
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Fziomed Received Approval From FDA an Independent Review of Its PMA for Oxiplex Gel
Nov 6, 2013FzioMed, a medical device company, has received approval from the commissioner of the US Food and Drug Administration (FDA) of its petition for an independent review of its premarket approval application (PMA) for Oxiplex Gel. Oxiplex is ...
Tags: FzioMed, Oxiplex Gel
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Cardiovascular Systems Obtained a Premarket Approval From FDA for Its Diamondback 360 Oas
Oct 24, 2013Cardiovascular Systems, a US-based medical device company, has obtained a premarket approval from the US Food and Drug Administration (FDA) for its Diamondback 360 coronary orbital atherectomy system (OAS), designed to treat severely ...
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Cardiofocus Concluded Enrollment of Its US Pivotal Trial Evaluating The Heartlight System
Oct 18, 2013CardioFocus, developer of the HeartLight endoscopic ablation system (EAS) for the treatment of atrial fibrillation (AF), has concluded enrollment of its US pivotal trial evaluating the HeartLight system, for the treatment of symptomatic ...
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Neuros Medical Has Obtained an IDE Clearance From FDA to Initiate a Randomized
Oct 12, 2013Neuros Medical, a US-based neurostimulation company, has obtained an investigational device exemption (IDE) clearance from the US Food and Drug Administration (FDA) to initiate a randomized, controlled pivotal clinical trial to evaluate the ...
Tags: Neuros Medical, Altius System
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Companion Diagnostic Tests Was Developed by Ventana Partners and Bi for Cancer Drugs
Sep 19, 2013Ventana Medical Systems,a member of the Roche Group, and pharmaceutical company Boehringer Ingelheim (BI) have entered into a collaboration agreement for the development of companion diagnostic tests for BI oncology programs. Companion ...
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Abbott Completed Its Acquisition of Idev Technologies
Aug 26, 2013Abbott has completed its acquisition of Idev Technologies, a privately held firm that manufactures next-generation medical devices for use by interventional radiologists, vascular surgeons and cardiologists, for $310m. Abbott believes ...
Tags: Abbott, Idev Technologies
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PFM Medical Received The Us Food and Drug Administration
Aug 26, 2013PFM Medical, a developer and manufacturer of minimally invasive medical devices for cardio vascular technology, vascular access, surgery, and oncology, has received the US Food and Drug Administration (FDA) premarket approval for its ...
Tags: PFM Medical, Medicine