Ventec Life Systems Gains FDA Clearance of VOCSN April 12, 2017 Patients can get all five therapies or just the mix of therapies needed. Read More
FDA Collaborates with Emulate to Use Organs-on-Chips Technology as a Toxicology Testing Platform April 11, 2017 The intention of this study is to predict the effects on human biology of chemical and microbiological hazards. Read More
Eyevensys Wins ANSM Approval for Clinical Development of Its EyeCET Platform April 11, 2017 The device is intended to treat ophthalmic diseases. Read More
REVA Receives CE Mark for Its Bioresorbable Coronary Scaffold April 11, 2017 This device is an alternative to metal stents to treat coronary artery disease. Read More
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
Industry Reps Cite Tight Timeline for MDUFA IV April 10, 2017 AdvaMed’s CEO praised “ground-breaking” process improvements in the MDUFA III agreement. Read More
European Parliament Adopts MDR and IVD Regs Without Amendment April 10, 2017 The regulations will create significant compliance headaches for manufacturers. 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
South Africa’s MCC Issues Draft Guideline on Quality Manuals April 7, 2017 Quality manuals must include information about the facilities, personnel and quality assurance policies and procedures. Read More
Witnesses Call for Cooperation on Cybersecurity April 7, 2017 Device cybersecurity is a “shared responsibility” among manufacturers, providers and all other stakeholders. 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