Israeli bio-medical engineering company ITGI Medical has signed a strategic cooperation agreement with Vascular Solutions, a medical device company, to commercialize ITGI's Aneugraft Dx coronary covered stent in the US market. Pursuant to ...
Tags: ITGI Medical, Aneugraft DX Stent
US-based Cochlear has announced that an advisory committee to the US Food and Drug Administration (FDA) voted favorably on the Cochlear Nucleus Hybrid L24 implant system. This is a first of its kind system designed for the treatment of ...
FDA regulators have released a report on Intuitive Surgical’s da Vinci system, which was based on responses from 11 surgeons who had used the system. The report covers complications, patient recovery times, training concerns, and ...
Tags: FDA Survey, Medicine
Guerbet announced that Novation has awarded a new agreement for Dotarem (gadoterate meglumine) injection. Dotarem injection is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain ...
Tags: Novation, Dotarem injection, Guerbet
Iceland-based Kerecis has obtained 510(k) approval from the US Food and Drug Administration (FDA) to market its fish-skin, Omega3, tissue-regeneration technology for the treatment of chronic wounds in the US. The company will market the ...
Tags: Kerecis, PDA, Fish-Skin Technology, chronic wounds
Hologic, a manufacturer of diagnostic products, medical imaging systems and surgical products, has announced that the US Food and Drug Administration (FDA) has approved the Aptima HPV 16 18/45 genotype assay for use on the company's fully ...
Tags: aptima HPV, Hologic, panther system
Medtronic has obtained the US Food and Drug Administration (FDA) approval for its Lead Integrity Alert (LIA) software for use with non-Medtronic leads to detect defibrillator lead issues. LIA software has been approved by the FDA to ...
Tags: Medtronic, PDA, LIA, non-medtronic
NanoBio Systems, a medical sensor startup company, has announced the successful measurement of glucose in saliva of human test subjects using a disposable nanotechnology-based sensor platform and simple, portable electronics. Limited ...
Topera, a US-based medical device company, has announced the US Food and Drug Administration (FDA) 510(k) approval and commercial availability of its FIRMap catheter and RhythmView 3D mapping workstation. For clinicians, the RhythmView 3D ...
Tags: Topera, clinician, firmap catheter, FDA approval
Glass Onion Catering has recalled about 181,620 pounds of salads and sandwich wrap products with chicken and ham, as they may be contaminated with E. coli O157:H7, the US Department of Agriculture’s Food Safety and Inspection Service ...
Tags: glass onion catering, recall, salad, sandwich
As the U.S. Food and Drug Administration announces its preliminary determination that partially hydrogenated oils are not “generally recognized as safe” (GRAS), global oils leader IOI Loders Croklaan is inviting food ...
Tags: Phos, IOI, trans-free, alternatives
The US Food and Drug Administration (FDA) has approved Sunovion Pharmaceuticals' (Sunovion) antiepileptic drug (AED) Aptiom (eslicarbazepine acetate) for the treatment of partial-onset seizures in patients with epilepsy. According to the ...
Tags: FDA, Sunovion, partial-onset seizure, epilepsy
The US Food and Drug Administration (FDA) has given 510(k) clearance for the marketing of Iceland-based Kerecis' proprietary fish-skin, omega-3, tissue-regeneration product for treating chronic wounds in the US. The product known as ...
Tags: Kerecis, Fish-Skin treatment, chronic wounds, FDA
Discovery Laboratories (DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, has initiated the US commercial launch of Surfaxin (lucinactant) Intratracheal Suspension for the ...
Vycor Medical (Vycor), a medical device company with a suite of FDA cleared products, announced the first release of its new "direct to the patient" saccadic eye training program to be marketed as NeuroEyeCoach. The company further ...
Tags: Vycor, NeuroEyeCoach, saccadic, release