IMRIS has obtained CE mark for its specialized multifunctional surgical theater called VISIUS iCT, designed for spinal and neurosurgical needs. Claimed to be the first ceiling-mounted intraoperative CT solution available in the market, ...
Tags: CE Mark, CT Solution
Quidel, a US-based virology assays and molecular diagnostic systems provider, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Sofia hCG fluorescent immunoassay for use on the Sofia Analyzer. It is used ...
Tags: FDA Clearance, HCG Fluorescent
TYRX, a provider of implantable cardiac devices, has announced the first implantation of its new AIGISRx R fully resorbable antibacterial envelope at the Vanderbilt Heart and Vascular Institute in Nashville, Tennessee. The second ...
Hologic has received the US Food and Drug Administration (FDA) clearance for its Single Energy (SE) femur exam, designed to visualize features associated with AFFs quickly and conveniently at the time of osteoporosis assessment. The quick ...
Tags: Hologic, FDA Clearance
NEC Display Solutions, a provider of commercial LCD display and projector solutions, has received the Food and Drug Administration 510(k) clearance for its 21-inch MultiSync MD211G5 medical-grade monitor. The LED-backlit IPS diagnostic ...
Convergent Dental has received the US Food and Drug Administration (FDA) clearance for its Solea, a CO2 laser system for ablation of hard tissue for caries removal and cavity preparation. Claimed to be the first 9.3μm CO2 computer ...
IntelligentMDx has secured clearance from the US Food and Drug Administration (FDA) for IMDx VanR for Abbott m2000 assay, an automated molecular diagnostic test that detects the presence of vanA and vanB genes associated with ...
Hologic's Aptima HPV assay has received clearance from the US Food and Drug Administration (FDA) for use on its fully-automated Panther system, enabling laboratories to run multiple tests from a single specimen. A nucleic acid amplified ...
Tags: Panther System, Aptima HPV Assay
Abbott has obtained approval from US Food and Drug Administration (FDA) for its inpatient blood glucose monitoring system, called FreeStyle Precision Pro Blood Glucose and Beta-Ketone Monitoring System, which provides test results in real ...
Tags: Abbott, Monitoring System
SynGen has received 510(k) approval from the US Food and Drug Administration (FDA) to market its SynGenX-1000 System, CryoPRO-2 Cryopreservation/Storage Bag Set, SynGen DataTrak software products to process cord blood. Previously, the ...
Tags: Cord Blood Processing, Syngen
US-based medical aesthetics provider Solta Medical has received 510(k) approval from the US Food and Drug Administration (FDA) for its Fraxel DUAL 1550/1927 laser system, which can be used to treat pigmented lesions including solar lentigos ...
St. Jude Medical, a medical device manufacturer, has received US Food and Drug Administration (FDA) approval for its next-generation Ellipse and SJM Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac ...
Tags: St.Jude, SJM Assura Devices
Respitek, a South Africa-based disposable medical devices maker, has received the US Food and Administration (FDA) clearance for the Bobbi Baby Shield, which is meant to shield against infection post Hypospadias repair surgery. Meant for ...
Tags: Respitek, Bobbi Baby Shield
US Food and Drug Administration intends to have tighter rules for apps that allow to diagnose or treat medical conditions, similar to the 2011 proposal urging for quality standards for ultrasound machines, heart stents, and several other ...
Tags: Stringent Rules, Medical Apps
Covidien has announced that its Nellcor pulse oximetry portfolio received the US Food and Drug Administration (FDA) 510(k) clearance for motion claims. The Nellcor pulse oximetry portfolio, which is used to measure arterial oxygen ...
Tags: Covidien, Motion Claims