True Diagnostics has obtained CE mark for TrueDXPSA, a quantitative prostate specific hormone (PSA) test. TrueDXPSA test will enable doctors to rapidly determine the PSA level in a patient. True Diagnostics president and CEO Jerry Lee ...
Tags: Diagnostics, clinical studies, health
With the introduction of the Morphologi G3-ID system last year, Malvern Instruments is providing researchers with the ability to apply morphologically directed Raman spectroscopy to a range of different sample types. Such advanced particle ...
The US Food and Drug Administration (FDA) has approved a new drug named Pomalyst (pomalidomide) for patients who received and did not respond to prior cancer therapies. Pomalyst, the third drug in a class of immunomodulatory agents ...
World Health Organization (WHO) has granted Performance, Quality and Safety (PQS) pre-qualified certification to PharmaJet's Stratis Needle-free Injector. The FDA-approved and CE-marked injector uses pressure to create a fine stream of ...
Tags: WHO, PQS, PharmaJet, Stratis Needle-free Injector
Fresenius Medical Care, a provider of dialysis products and services, has unveiled WetAlert wireless wetness detector to detect venous needle displacement (VNS) and prevent blood loss during home dialysis. The FDA-approved WetAlert ...
Tags: Fresenius Medical Care, WetAlert wireless wetness detector, VNS
Planmed Oy has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Planmed Verity Extremity Scanner for providing fast 3D imaging of subtle extremity fractures that have been missed when using 2D radiographs at ...
US-based Modern Plastics has announced that a spinal implant device using Evonik's VESTAKEEP PEEK (polyetheretherketone) has obtained 510(k) clearance from the US Food and Drug Administration (FDA). The implant device, which exhibits ...
Tags: Modern Plastics, Evonik, VESTAKEEP PEEK, FDA
Clinical stage biopharmaceutical company Apogenix's Apocept (APG101) has won FDA orphan drug designation to treat myelodysplastic syndromes (MDS). Apogenix also announced the commencement of Apocept Phase I trial in MDS patients in ...
Tags: FDA, orphan drug, biopharmaceutical
Covidien has announced two-year clinical study results of its Solitaire FR revascularization device, designed for treating acute ischemic stroke. The FDA-approved and CE-marked mechanical thrombectomy device uses overlapping stent ...
Tags: clinical study, Covidien, FDA
The US Food and Drug Administration (FDA) has granted 510(k) approval to Zoll Medical's fully automatic version of ZOLL AED Plus. Using the company's proprietary feedback technology, Real CPR Help, the new fully automatic device provides ...
Tags: FDA, ZOLL AED Plus, Medical
The US Food and Drug Administration (FDA) has granted 510(k) approval to Ethicon Endo-Surgery's ENSEAL G2 Articulating Tissue Sealer, designed to allow surgeons to take a perpendicular approach to seal vessels up to 7mm in diameter and ...
EnteroMedics has reported ReCharge study results of its VBLOC vagal blocking therapy, designed for the treatment of obesity. The pacemaker-like Maestro system delivers VBLOC therapy via two small electrodes that are laparoscopically ...
The US Food and Drug Administration (FDA) has approved Elite Pharmaceuticals' supplemental application for naltrexone hydrochloride 50 mg tablets. Naltrexone, an opioid receptor antagonist, is used primarily to manage alcohol dependence ...
Tags: FDA, Pharmaceuticals, naltrexone tablets
The US FDA has approved Warner Chilcott's 400mg mesalamine product as new ulcerative colitis therapy, to be marketed as Delzicol. Warner expects to commercially launch Delzicol in March 2013. Delzicol delayed-release capsules are ...
US-based Smiths Medical has gained US marketing rights for its CADD-Solis variable infusion profile (VIP) ambulatory infusion system, following the US Food and Drug Administration (FDA) approval. The multi-therapy infusion system, which ...
Tags: FDA, therapy infusion system, Medical