US-based Dallen Medical has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Tensyn band, designed for the fixation of ankle syndesmosis. Previously, the company has obtained FDA 510(k) clearances for its ...
Tags: Dallen Medical, Tensyn Band
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
The US Food and Drug Administration (FDA) has approved Janssen Therapeutics' NS3/4A protease inhibitor 'Olysio (simeprevir)' for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with ...
Attending for the first time to the most important fair in the denim market, MACTEC brings forward the Paris winter with a breeze of frozen air to the next edition of Denim by Première Vision. It’s all about ICELITE, the ...
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
Israeli device manufacturer ITGI Medical announced a new partnership with Vascular Solutions. Under the new agreement, both companies will work together to land a Humanitarian Device Exemption (HDE) from FDA regulators for the ITGI ...
The FDA recently announced another Class I recall, this time in the cardiovascular space. The faulty products from Medtronic are guidewires with surface coatings that could potentially divide and detach. The Fridley, MN-based medical ...
Mobile cardiovascular health firm AliveCor (San Francisco, CA) has announced the debut of AliveInsights, a new service that enables patients to send ECG data generated by the company's heart monitors to cardiologists or cardiac technicians ...
Tags: ECG, Heart Monitors, Smartphone
Medtronic is touting a potential advance in the cardiovascular space: a recent study that shows some of the smarter algorithms it is using in its pacemakers actually slow the development of atrial fibrillation. The MINERVA study, ...
Tags: Pacemakers, Slow Heart, Rhythm Disorder
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 ...
US-based specialty pharmaceutical firm Impax Laboratories (Impax) has started shipment of generic Solaraze (diclofenac sodium gel, 3%), a first-to-file product, through its generics division Global Pharmaceuticals. In order to ...
US-based HD Medical has announced the launch of its ViScope MD visual stethoscope with murmur detection indicator at MEDICA, 20 November through 23 November 2013, in Germany. ViScope MD features an integrated visual display which allows ...
Tags: HD Medical, Medicine
CIVCO Medical Solutions, a medical technology company, has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its EX3 stepper, which is used while performing real time planning for low dose rate (LDR) or high dose ...
Tags: CIVCO Medical, Medicine
TauTona, a medical device firm, has obtained 510(k) approval from the US Food and Drug Administration (FDA) and a new patent from the US Patent and Trademark Office (USPTO) for the TauTona tissue injector (TTI), a hand-held adipose tissue ...
Tags: Tautona, Transfer Tool
Based in Fargo, ND, CSM is a full-service packaging and labeling company that specializes in supplying investigational medicines, including cancer drugs and supplies for clinical trials. CSM's licensed pharmacists and pharmacy technicians ...