All articles by Srivari Aishwarya
Instrumentation Laboratory obtains FDA 510(k) clearance for GEM Premier 5000
Instrumentation Laboratory (IL) has received US Food and Drug Administration (FDA) 510(k) clearance for GEM Premier 5000, an in-vitro diagnostic (IVD) analyser combined with Intelligent Quality Management 2 (iQM2).
Ayoxxa and Märzhäuser launch Ayoxxa Reader AR01 for protein multiplex analysis
German establishments Ayoxxa Biosystems and Märzhäuser Wetzlar have introduced a new device for protein multiplex analysis.
US FDA grants approval for Luminex’s NxTAG respiratory pathogen panel
Luminex has secured approval from the US Food and Drug Administration (FDA) for its NxTAG respiratory pathogen panel that is capable of detecting simultaneously 20 clinically relevant viral and bacterial respiratory pathogens.
BiO2 Medical completes Angel Catheter clinical investigation
US-based medical device manufacturer BiO2 Medical has completed clinical investigation of the Angel Catheter for pulmonary embolism (PE) protection.
Halozyme and Ventana to develop companion diagnostic assay for cancer treatment
Halozyme Therapeutics and Roche’s Ventana Medical Systems have reached an agreement to jointly develop a companion diagnostic assay to treat cancer.
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CorMatrix Cardiovascular secures patents for biomaterial replacement heart valve in US
CorMatrix Cardiovascular has received three patents in the US for its replacement heart valves that use a biomaterial called extracellular matrix (ECM).
Cerevast Therapeutics initiates patient enrolment for ultrasonic headframe clinical trial
Cerevast Therapeutics, a US-based medical technology firm, has begun enrolling patients for the Phase III clinical trial to evaluate the use of Clotbust ER ultrasonic headframe, which is meant for the treatment of acute ischemic stroke.
Teleflex subsidiary receives 510(k) clearance for balloon dilatation catheters
US-based Teleflex’s subsidiary Hotspur Technologies has received US regulatory clearance to market its ARROW GPSCath balloon dilatation catheters in higher rated burst pressure (RBP) and 80cm in length.
Stereotaxis wins US clearance to market Vdrive with V-Sono System
US-based Stereotaxis has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Vdrive Robotic Navigation System with V-Sono Intracardiac Echocardiography (ICE) catheter manipulator.
PPG Industries to sell stake in photochromic lens unit for $1.73bn
US-based specialised chemicals firm PPG Industries has agreed to sell its 51% stake in Transitions Optical to France-based Essilor International for $1.73bn.