Fujifilm Medical Systems U.S.A., a provider diagnostic imaging products and medical informatics solutions, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Gadolinium and Cesium digital X-ray detectors for ...
Germany-based TomTec Imaging Systems has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its TomTec-Arena 1.0 software solution. TomTec-Arena 1.0 is the newest addition to the company's product portfolio. ...
US-based Claret Medical has submitted an investigational device exemption (IDE) application to the US Food and Drug Administration (FDA) for a multicenter study of the company's Sentinel cerebral protection system (CPS) for embolic ...
W. L. Gore & Associates, Inc. (Gore) has received Shonin approval from the Japanese Ministry of Health, Labor and Welfare to market the GORE EXCLUDER AAA endoprosthesis featuring C3 Delivery System as a minimally invasive treatment for ...
NEC Display Solutions of America has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its 24-inch MultiSync MD242C2 widescreen display for diagnostic review applications in healthcare organizations. MultiSync ...
Lowering CT dose and improving workflow are not choices that clinicians should have to make, so Toshiba CT is putting customers first by providing the industry's best solutions to solve these challenges. To make complex exams easier, ...
First it was leaky battery damage. Now it is pressure sensor calibration drift. For the second time this year, the FDA has classified a Hospira recall of its GemStar Infusion System as Class I, which means there is potential for ...
Royal Philips has introduced its Vereos PET/CT fully digital positron emission tomography/computed tomography (PET/CT) imaging system and its IQon Spectral CT spectral detector-based computed tomography (CT) imaging system at the 99th ...
Tags: CT System, spectral detector
The US Food and Drug Administration (FDA) has approved Vifor Pharma's hyperphosphatemia drug Velphoro for the control of serum phosphorus levels in patients with Chronic Kidney Disease (CKD) on dialysis. Approval of Velphor, which is an ...
Tags: Drug, phosphate binder
Sumitomo Heavy Industries has obtained the US Food and Drug Administration (FDA) 510(k) clearance of its Proton Therapy System, a form of radiation therapy, which employs proton beams to kill cancer cells with better dose distribution in ...
Tags: Proton Therapy System, Sumitomo
Alfred Louie, a California-based food company, has halted production after the US Food and Drug Administration (FDA) inspectors found unsanitary conditions at the premises. Eastern District of California Judge Garland E. Burrell has ...
US-based Bruker has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its MALDI Biotyper CA system to identify Gram negative bacterial colonies cultured from human specimens. Bruker's MALDI Biotyper CA system ...
VBL Therapeutics has secured fast track status from the US Food and Drug Administration (FDA) for its lead oncology drug VB-111, for prolongation of survival in patients with Recurrent Glioblastoma Multiforme (rGBM). VB-111 was already ...
US-based BioMedical Enterprises (BME) has obtained the US Food and Drug Administration (FDA) clearance (K131640) for its upgraded HammerLock Nitinol intramedullary fixation system for hammertoe deformities. The patent-pending HammerLock ...
Packaging Coordinators (PCI) has announced plans to expand its clinical packaging business operations by opening a new facility in Rockford with an investment of about $8m. The new building will be located in the Logistics industrial park ...