In accordance with OSHA Safety Standards, any product used in the workplace must be approved by a Nationally Recognized Testing Laboratory (NRTL). This is needed to ensure that products can be used safely in the workplace. The NRTL approval ...
Tags: NRTL Certification, NRTL, certification
A, CCC Certification CNCA authorized by the state under the state compulsory product certification (CCC) work. Second, CQC logo certification CQC facilities in order to increase the way of signs show that the products meet ...
Tags: CQC Certification, certification, CQC
IMRIS, an image-guided therapy solutions provider, has obtained Therapeutic Goods Administration (TGA) regulatory clearance for its ceiling-mounted VISIUS intraoperative computed tomography (iCT). IMRIS, an image-guided therapy solutions ...
Tags: IMRIS, Regulatory Clearance, Intraoperative CT Solution
Tryton Medical, a developer of stents designed to treat bifurcation lesions, has received CE Mark for the treatment of left main coronary artery disease. With this approval, Tryton Medical becomes the first company to earn a CE Mark for ...
Tags: Tryton Medical, CE-Mark
Solos Endoscopy, a provider of healthcare instruments to hospitals across the US, announce that the company has received its ISO 13485:2003 Certification from TUV SUD America. The certification to ISO 13485:2003 will in turn allow Solos ...
Tags: TUV SUD, FDA, ISO Certified, MammoView
Sapheon has announced the Health Canada approval for its VenaSeal sapheon closure system, designed to treat venous reflux disease (varicose veins). VenaSeal features a specially formulated medical adhesive that closes the saphenous vein. ...
Benvenue Medical, a medical device company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Kiva VCF treatment system for the reduction and treatment of spinal fractures. The FDA marketing clearance is ...
ReCor Medical has announced major advances in its Paradise System for renal denervation (RDN), confirming its commitment to lead in the treatment of patients with resistant hypertension (HTN). The company announced that it has received ...
Tags: renal denervation system, health, HTN
US-based Claret Medical has obtained CE Mark approval for Sentinel Cerebral Protection System, the next generation product in its embolic protection portfolio. Claret Medical's Sentinel cerebral protection system (CPS) is designed for ...
Tags: CPS, TAVR, filter system, exemption
Medtronic, a medical device company, has obtained the US Food and Drug Administration (FDA) approval for its CoreValve self-expanding transcatheter system. The device is designed for severe aortic stenosis patients who are too ill or ...
Tags: medical device, Medtronic
Aligned with its commitment to help move reproductive health management forward, Beckman Coulter Diagnostics has received clearance for its new Access Total βhCG (5th IS) assay from the U.S. Food and Drug Administration (FDA) 510(k), ...
Marking a milestone in the evolution of fully-bioresorbable drug-eluting scaffolds for interventional cardiology, the first commercial implant of Elixir Medical's CE Mark-approved DESolve Novolimus Eluting Coronary Scaffold was performed in ...
Integrity Applications and Ultramedix Australasia have signed an agreement for the distribution of Integrity Applications’ GlucoTrack non-invasive blood glucose measurement device in Australia and New Zealand. Subject to the ...
Mylan, Inc. (Nasdaq: MYL) today announced that Zyomyx's MyT4™ point-of-care CD4 diagnostic test has received the CE Certificate of Conformity in the European Union, an important step toward launching this innovative test and expanding ...
Tags: Mylan, Zyomyx's MyT4™point-of-care CD4, diagnostic test, HIV
Direct Flow Medical (Santa Rosa, CA) has obtained the CE Mark for its 29-mm transcatheter aortic valve replacement device, which it hails as the first fully repositionable percutaneous heart valve. The ability to reposition the Direct Flow ...