News

Venaxis Receives FDA “Not Substantially Equivalent” Response on APPY1 510(k) Submission

Venaxis, Inc. today announced the United States Food and Drug Administration (“FDA”) has determined that the APPY1 Test does not meet the criteria for substantial equivalence based upon data and information submitted by Venaxis in its 510(k) submission.  Read more…



Venaxis, Inc. to Present at Biotech Showcase™ 2015

Venaxis®, Inc. today announced it will be presenting at the Biotech Showcase™ 2015, being held January 12-14, 2015, at the Parc 55 Wyndham Union Square Hotel in San Francisco, California.  Read more…



Venaxis Files Response to FDA’s Request for Additional Information

Venaxis®, Inc. today announced it has filed its response to the FDA’s Additional Information (AI) request related to the Company’s APPY1 direct de novo submission. Venaxis will provide a business update, including discussion on the APPY1 FDA submission, on Monday, December 8, 2014, at 4:30 p.m. ET. The conference call will be hosted by Steve Lundy, President and CEO.  Read more…