In vitro diagnostic company Venaxis has filed for CE mark approval of blood-based appendicitis test, APPY1, in Europe. The company expects to receive CE Mark by the end of 2012 and anticipates initiating commercialization in first quarter ...
Tags: appendicitis test, blood based appendicitis test, FDA, Venaxis
The US FDA has approved Chembio Diagnostics' Dual Path Platform (DPP) point-of-care HIV 1/2 rapid test. The DPP HIV 1/2 assay is developed to detect HIV-1/2 antibodies in either oral fluid or blood samples, which will bind directly with ...
Tags: FDA, HIV, oral fluid, detection reagents
Lexicon Pharmaceuticals has won Fast Track status from the US FDA to develop LX1033, an orally-delivered small molecule drug candidate to treat diarrhea-predominant irritable bowel syndrome (IBS-d). Fast Track facilitates the development ...
Tags: Lexicon Pharmaceuticals, small molecule drug candidate
Medical devices often use commercial PCs and have wireless connections that make them vulnerable to malware, or require software updates for security, but the U.S. may not be doing an adequate job tracking these risks, researchers ...
Tags: Medical-Device Security, security IT, malware, computer technology
Pacemakers from several manufacturers can be commanded to deliver a deadly, 830-volt shock from someone on a laptop up to 50 feet away, the result of poor software programming by medical device companies. The new research comes from ...
Tags: Pacemakers, shock, laptop, software programming, medical device companies
Angiotech Pharmaceuticals has gained US marketing rights for its Bio-Seal Lung Biopsy Tract Plug system, following the approval from the US Food and Drug Administration (FDA). Featuring a proprietary hydrogel plug, the proprietary biopsy ...
Dendreon Corporation has sold its immunotherapy manufacturing facility (IMF) in Morris Plains, New Jersey, US, to Novartis Pharmaceuticals for $43m. In early 2012, Dendreon had decided to bring down Provenge production at the facility as ...
Tags: Novartis, Dendreon immunotherapy, manufacturing facility, Medicine
Semantelli has launched a healthcare focused big data collection solution, which is built with Apache Hadoop and other standard big data stacks. BIGHEALTHr solution, which comes with built-in ontologies, can be configured to collect big ...
The study examines the medical device coating and surface modification treatment industry, a global enterprise that BCC Research anticipates will reach nearly $8 billion by 2017. It describes the eight coating and surface treatment ...
Tags: medical device, coating and surface modification treatment industry
University Medical Center Groningen (UMCG) has treated the first patient using its RePneu lung volume reduction coil (LVRC), designed for relieving breathing difficulty in patients with severe emphysema, in RENEW pivotal trial. The ...
AMC Health will offer an array of telemonitoring services for clinical trial of lisinopril, which will be conducted by Transparency Life Sciences (TLS). US FDA has granted Investigational New Drug (IND) status to Lisinopril, which allows ...
Tags: AMC Health, Telemonitoring Services, clinical trial, Medicine
New Zealand has signed an arrangement with the US Food and Drug Administration (FDA), under which each country will recognize the other's food safety system as providing a comparable degree of food safety assurance. The Food Safety ...
Tags: food safety system, comparable degree, food safety assurance
US-based Ocean Beauty Seafoods is voluntarily recalling 371 cases of ready-to-eat cold smoked salmon products as they may be contaminated by Listeria monocytogenes. The products subject to recall include Nathan's Brand 3oz Cold Smoked ...
Tags: ready-to-eat cold smoked salmon, Listeria monocytogenes, products recall
Gerresheimer AG, one of the world’s leading partners of the pharma and healthcare industry, today announced that it has acquired the majority shareholding in the Indian company Triveni to further accelerate its growth in the emerging ...
Tags: Gerresheimer, Indian Pharma Plastic Packaging, Decoration
The US Food and Drug Administration (FDA) has granted regulatory approval to Avinger's Ocelot | PIXL. Ocelot | PIXL, which is supported by the company's Lightbox console, enables physicians to navigate lesions with a choice between 135cm ...