Mauna Kea Technologies has obtained CE mark for its UroFlex confocal miniprobe, designed for use in urological applications. The optical biopsy probe, the first urological probe in the Cellvizio portfolio, provides physicians with an ...
Tags: Mauna Kea Technologies, CE mark, TURBT
The European Union has granted CE mark approval to BiO2 Medical's inferior vena cava(IVC)filter for use in critically ill patients who are at increased risk of pulmonary embolism and temporarily contraindicated for anticoagulation therapy. ...
Tags: European Union, CE mark approval, BiO2 Medical, IVC filter
BG Medicine has registered a 510(k) premarket notification with the US Food and Drug Administration (FDA) for approval of its Architect Galectin-3 assay. The Architect Galectin-3 assay, which is designed for use with Abbott's automated ...
Tags: BG Medicine, premarket notification, FDA, Architect Galectin-3 assay
Advanced Biological Laboratories (ABL) has received CE mark approval for its DeepChek and ViroScore Suite clinical genotyping solutions. The approval is based on several evaluations of the company's next generation sequencing (NGS) ...
Tags: Advanced Biological, ABL, CE mark approval, evaluations
The European Union has granted CE mark to ClearCanvas' new medical imaging informatics solution. The RIS/PACS solution features customizable worklists, hanging protocols, roaming user profiles as well as offers advanced functionality to ...
Tags: CE mark, medical imaging informatics solution, RIS/PACS solution
Guided Therapeutics has extended third consecutive year licensing agreement with Konica Minolta Technology Center to co-develop a non-invasive Barrett's Esophagus detection product. The Barrett's Esophagus product is based on the Guided ...
Tags: Guided, licensing agreement, Konica, co-develop
Medtronic has obtained the CE mark approval for its Sentrino continuous glucose monitor (CGM), designed for use in hospital critical care units (CCU). Designed to optimize glucose management, the minimally invasive system displays ...
Tags: CGM, continuous glucose monitor, Medtronic, CCU
The European Union has granted CE mark approval to InSightec's transcranial focused ultrasound system for the treatment of essential tremor, tremor dominant Parkinson's disease and neuropathic pain. The non-invasive ExAblate Neuro ...
Tags: transcranial focused ultrasound system, Parkinson's disease
TranS1 has obtained CE mark approval for its VEO minimally invasive lateral access fusion system for interbody fusions. The VEO lateral fusion system, featuring two-stage retraction method that focuses on nerve visualization and then ...
Tags: TranS1, VEO lateral fusion system, lateral interbody implants
IntelligentMDx has received CE mark approval for its automated molecular HSV-1/2 test, designed for the Abbott m2000 system. The HSV-1/2 for Abbott m2000 assay detects Herpes Simplex Virus (HSV) viral DNA and differentiates HSV-1 and ...
Tags: IntelligentMDx, HSV-1/2 test, Abbott m2000 system, HSV
Cytori Therapeutics has expanded its Celution system's CE mark approval to include several new indications including cryptoglandular fistula. The Celution system, which pulls stem cells and other regenerative cells out of fat , provides ...
Tags: Cytori Therapeutics, cryptoglandular fistula, celution system
Sequenom's European licensing partner LifeCodexx has launched its Praena test service in more than 70 prenatal clinics and hospitals in Germany, Austria, Liechtenstein and Switzerland following the CE mark approval. LifeCodexx CEO Michael ...
Tags: Praena test, LifeCodexx, Sequenom
True Diagnostics has gained CE-mark approval to distribute its TrueDX platform and quantitative thyroid-stimulating hormone (TSH) test in Europe. The TrueDX platform helps physicians to determine whether a patient suffers from a ...
Tags: TrueDX platform, thyroid-stimulating hormone test, TSH test
BG Medicine has filed 510(k) premarket notification for regulatory clearance of an expanded indication for its BGM Galectin-3 test with the FDA. The blood test is at present indicated for use in patients with chronic heart failure who are ...
Tags: BG Medicine, blood test, heart failure
The US Food and Drug Administration (FDA) has cleared Bausch + Lomb's enVista glistening-free, single-piece hydrophobic acrylic Intraocular Lens (IOL). enVista lens, developed by Advanced Vision Science (AVS), is designed to provide ...
Tags: FDA, Bausch+Lomb's, enVista lens