A biomedical engineer is developing a clinical-grade open-source 12-lead ECG. The device includes support for Android devices and is designed to meet all relevant medical device manufacturing standards, like ISO 60601-1. According to early ...
Kinetic Concepts (KCI) has obtained the US Food and Drug Administration (FDA) approval for its next generation V.A.C.Via negative pressure wound therapy system. The V.A.C.Via therapy system is a single-patient-use, ultra-portable V.A.C. ...
Tags: Therapy System, Medicine
AtriCure, a developer of solutions to treat atrial fibrillation (Afib), has announced the US Food and Drug Administration’s (FDA) approval to begin enrollment in a clinical study of its AtriClip left atrial appendage exclusion system. ...
Tags: AtriCure, Stroke Prevention
Biotronik, a manufacturer of cardiovascular medical devices, has obtained the US Food and Drug Administration (FDA) approval for Phase B of the company’s ongoing ProMRI clinical trial. Biotronik has recently completed Phase A of the ...
Tags: Promri Clinical Trial, Biotronik
A new technology based on fish skin can be used to heal human skin wounds. This week, Kerecis Limited announced that it received FDA 510(k) clearance for a fish skin-based tissue regeneration technology. The technology is designed for the ...
Tags: Tissue Regeneration Technique, FDA
US-based Iroko Pharmaceuticals has entered into a $75m debt facility agreement with an affiliate of OrbiMed Advisors (OrbiMed) to support general business operations and the launch of Zorvolex (diclofenac). Zorvolex is the first and only ...
The US Food and Drug Administration (FDA) has accepted AstraZeneca's new drug application (NDA) for naloxegol, an investigational peripherally-acting mu-opioid receptor antagonist (PAMORA). The drug has been studied in opioid-induced ...
Tags: Drug Application, FDA Approval
Posted in Cardiovascular by Qmed Staff on November 19, 2013 The Sapien 3 could be used in a broader range of patients than earlier TAVR products introduced internationally. Edwards Lifesciences (Irvine, CA) is in the news after The ...
Intellipharmaceutics International has announced that the US Food and Drug Administration (FDA) has granted final approval of the company's dexmethylphenidate hydrochloride extended-release capsules for the 15 and 30mg strengths. ...
Tags: Focalin XR, Medicine
Valeant Pharmaceuticals North America, a wholly-owned subsidiary of Valeant Pharmaceuticals International, has received a notice that the new drug application for Luzu (luliconazole) cream, 1% has been approved by the US Food and Drug ...
Lavender essential oils have been used in European hospitals, mainly France, for treating burns. But that is not the only application of lavender that has proven itself. Insomnia and anxiety relief are the most common uses aside from burns. ...
Tags: essential oils, Agriculture
In August, Medtronic was forced to remove its CoreValve percutaneuous heart valves from the market in Germany in light of a ruling that found that the device infringed on patents held by Edwards Lifesciences. A German appeals court, ...
Johnson & Johnson (JNJ) subsidiary Janssen Biotech and Pharmacyclics (PCYC) have won approval from the US Food and Drug Administration (FDA) for their breakthrough therapy Imbruvica (ibrutinib) to treat patients with mantle cell lymphoma ...
Tags: Johnson&Johnson, MCL Patients
A.P. Pharma, a specialty pharmaceutical company, has initiated a program to expand its pipeline of sustained release products, including a new program targeting the relief of post-surgical pain. The company also announced it will pursue a ...
Tags: A.P.Pharma, Pipeline Expansion
Iceland-based Kerecis has obtained 510(k) approval from the US Food and Drug Administration (FDA) to market its fish-skin, Omega3, tissue-regeneration technology for the treatment of chronic wounds in the US. The company will market the ...
Tags: Kerecis, PDA, Fish-Skin Technology, chronic wounds