FDA Grants Clearance for Alere Reader Platform and Alere BinaxNOW Influenza A & B Card 2 April 11, 2017 The device received CE marking in August 2016. Read More
FDA Approved Expanded Indication of Marketing Clearance for Verax PGD Test April 10, 2017 The device is FDA cleared as a safety measure for bacterial contamination in platelets. Read More
FDA Grants Marketing Approval for First Direct-to-Consumer Genetic Tests April 10, 2017 The tests were approved through the de novo premarket review pathway. Read More
Intralytix Receives FDA Clearance for Phage-Based Shigella Technology April 7, 2017 The company already has three approved phage-based products on the market. Read More
FDA Clears Roche CINtec Histology Test April 7, 2017 The test is a part of the Roche cervical cancer portfolio. Read More
FDA Grants Marketing Approval for First Direct-to-Consumer Genetic Tests April 7, 2017 The FDA has issued marketing approval for the first direct-to-consumer genetic tests to assess inherited risks for 10 diseases. Read More
Understanding When an Accessory is a Device April 7, 2017 When is an accessory a device for which an application needs to be submitted to the FDA, and how is the accessory classified? Read More
BD Gains FDA Clearance For New Flow Cytometer System with Leucocount Reagent Assay April 6, 2017 The device operates like a full-function clinical flow cytometer but in a compact design. Read More
FDA Grants Marketing Clearance to Bausch + Lomb’s Stellaris Elite Phacoemulsification Platform April 6, 2017 The company plans to release retina applications for the Stellaris Elite this summer. Read More
Occlutech Obtains CE Mark for its PmVSD Occluder April 5, 2017 The device consists of a flexible nitinol wire mesh with "shape-memory" properties. Read More
AirXpanders Receives FDA Clearance for Modified AeroForm Tissue Expander April 5, 2017 AeroForm administers small amounts of carbon dioxide to gradually stretch breast tissue. Read More
Milestone Gains Marketing Clearance for Epidural and Intra-Articular Instruments in Australia April 4, 2017 The devices utilize DPS technology. Read More