The US Food and Drug Administration (FDA) has granted 510(k) approval to Teleflex Incorporated's ArrowADVANTAGE5 non-coated pressure-injectable peripherally inserted central catheter (PICC) for central venous pressure (CVP) monitoring ...
Tags: pressure-injectable, central venous pressure, CVP, central catheter
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Masimo's new uSpO2 universal pulse oximetry cable for use with GE Healthcare's patient-worn monitors in ambulatory patient care environments. The uSpO2 cable is an ...
Tags: pulse oximetry cable, patient care environments, pulse oximetry device
Sotera Wireless has won FDA 510(k) clearance for its full ViSi Mobile System and is commencing sales to hospitals nationwide. The ViSi Mobile System, which consists of a small device and non-invasive sensors for freedom of movement, is ...
Immunetics,a developer of infectious disease diagnostic tests,has appointed John Yonkin as the company's new chief executive officer(CEO),effective from 1 December 2012. Prior to joining Immunetics,Yonkin served at Alere as vice president ...
Tags: Immunetics, infectious disease diagnostic tests, BacTx rapid test
Cancer Treatment Centers of America(CTCA)at Western Regional Medical Center(WRMC)in Arizona,US,has purchased BSD Medical's BSD-2000 Hyperthermia system. CTCA,which is comprised of a network of hospitals including WRMC,provides effective ...
Tags: CTCA, BSD 2000 Hyperthermia system, cancer treatments, WRMC
Global provider of medical device solutions Symmetry Medical has obtained United States Food and Drug Administration's (for its FLASH PAK Evolution valve. The valve, which is distributed exclusively by Symmetry Surgical, is designed ...
Tags: medical device solutions, Symmetry Medical, Symmetry Surgical
SYSPRO, which offers enterprise resource planning (ERP) software for on-premise and cloud-based utilization, has developed SYSPRO ERP, which enables food manufacturers and distributors to fully comply with the newest rules recently issued ...
Tags: SYSPRO, ERP Software, Food Manufacturers
Cohera Medical has completed enrolling patients in a US clinical study of its internal TissuGlu surgical adhesive. TissuGlu, which adheres the tissue flap created during the procedure, is designed to help eliminate fluid accumulation and ...
OptiMedica has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its new Catalys Precision Laser system, designed for creating single-plane and multi-plane arc cuts/incisions in the cornea during performing ...
Tags: OptiMedica, US Drug Administration, Catalys Precision Laser system
William Beaumont Hospital, a three-hospital regional health system, has purchased BSD Medical's MicroThermX Microwave Ablation system. The MicroThermX system, which features a microwave generator, single-patient-use disposable antennas, ...
Clinical-stage biopharmaceutical company OXiGENE's acute myelogenous leukemia (AML) drug candidate, OXi4503, has received FDA orphan drug status. The second-generation anticancer agent with a dual-mechanism vascular disrupting feature ...
The British Standards Institution (BSI), a notified body under the Medical Device Directive, has awarded a CE mark for the expanded clinical indication for Harvest Technologies' SmartPReP 2 Bone Marrow Aspiration Concentration System (BMAC ...
Dune Medical Devices has obtained an approvable letter related to its premarket approval application (PMA) for the breast cancer detection system from the US Food and Drug Administration (FDA). The letter indicates that the system's PMA ...
US-based Newman's Own is voluntarily recalling its Lite Honey Mustard Dressing as it contains milk which is not mentioned on the label, according to the US Food and Drug Administration (FDA). The recall was initiated after it was found ...
Tags: Newman's Own, recalling, lite honey mustard dressing, milk, FDA
SportsQuest has announced that its wholly owned subsidiary, Maize Pluss, has signed a contract to distribute organic stevia, an USDA FDA approved organic sweetener. SportsQuest CEO Jeff Burns said that the company is building a very ...
Tags: SportsQuest, Distribution Contract