UK-based Randox Food Diagnostics is set to unveil a generic Tetracyclines ELISA screening kit based on Biochip Array Technology for veterinary residue testing. The company will launch the ELISA kit by the end of this month to complement ...
Tags: Randox Food, Screening Kit
Hologic, a developer of medical imaging systems and surgical products, has received approval for its Aptima HPV assay for use on its fully-automated Panther system from the US Food and Drug Administration (FDA). The assay is a nucleic ...
Tags: Aptima HPV, Medicine
IMRIS has secured US Food and Drug Administration (FDA) 510K approval to market its VISIUS iCT, a ceiling-mounted intraoperative computed tomography (iCT). VISIUS iCT serves a surgical theater, providing personalized dose management along ...
Tags: Visius ICT, Medicine
Clinical-stage pharmaceutical company Adynxx has obtained the US Food and Drug Administration (FDA) fast track designation for its AYX1 injection, which is used for prevention of chronic pain. In a five-cohort, dose-escalating study ...
The US Food and Drug Administration (FDA) has banned the imports of salmon produced in Chile by Norwegian multinational firm Marine Harvest after a carcinogenic chemical known as crystal violet was detected in a shipment. Crystal violet ...
Tags: Salmon, carcinogenic chemical
Hagee Foods, dba Penny's Salsa, is recalling hummus products in the US as they may be contaminated Listeria monocytogenes. The retail hummus products come in 8 oz. and 12 oz. clear plastic packages and were distributed to retail stores ...
Tags: Hagee Foods, Hummus Products, Health Risk
SynGen has received 510(k) approval from the US Food and Drug Administration (FDA) to market its SynGenX-1000 System, CryoPRO-2 Cryopreservation/Storage Bag Set, SynGen DataTrak software products to process cord blood. Previously, the ...
Tags: Cord Blood Processing, Syngen
The US Food and Drug Administration (FDA) has issued a Class I recall of Medtronic’s MiniMed Paradigm Insulin Infusion Sets. The Paradigm infusion sets are meant for use with Paradigm insulin infusion pumps. These infusion sets are ...
Luminex has received approvals from the US Food and Drug Administration (FDA) and EU authorities for the new version of xTAG CYP2D6 (Cytochrome P450 2D6) Kit. An IVD assay, the xTAG CYP2D6 Kit analyses a patient's CYP2D6 genotype from ...
Mylan Pharmaceuticals, Mylan's US subsidiary, has launched one of the first generic versions of Abbott's Trilipix Capsule in the US. Known as Fenofibric Acid Delayed-release Capsules, 45mg and 135mg is indicated for patients with mixed ...
Olde Thompson is recalling 1,075 cases of Earth’s Pride Organics Organic Oregano packed in 2.2oz. glass jar due to possible contamination by Salmonella, according to the US Food and Drug Administration (FDA). The recall affects ...
The US Food and Drug Administration (FDA) has cleared Boehringer Ingelheim's tyrosine kinase inhibitor Gilotrif (afatinib) as a new medication for patients with late stage (metastatic) non-small cell lung cancer (NSCLC). The approval also ...
Tags: FDA, Lung Cancer Therapy, Medicine
Boston Scientific's Guidezilla Guide Extension Catheter has secured 510(k) approval from the US Food and Drug Administration (FDA) and CE Mark, which would enable the company to market the device in the US and European markets. The ...
The US Food and Drug Administration (FDA) has permitted the sale of Verify Cronos Self Contained Biological Indicator (SCBI), a new quicker testing method to check the effectiveness of steam sterilization of reusable medical devices. ...
CryoLife has received premarket approval from the US Food and Drug Administration (FDA) for its new Sologrip, a minimally invasive laser fiber-optic delivery system. The Sologrip delivery system is a single-use, disposable handset ...