Biosensors are changing how we monitor health, but rapid innovation raises tough questions around privacy, regulation, and access. This article breaks down the key issues shaping their future.

AliveDx announces it has submitted 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the ...

Microbix is ISO 9001 & 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides IVDR-compliant CE marked products. Microbix also applies its ...

About Proclarix ® Proclarix ® is CE-certified under In Vitro Diagnostic Regulation (“IVDR”) and indicated for prostate cancer diagnosis in patients with normal digital rectal exam (DRE), enlarged ...

Under IVDR, clear and specific IVD intended use criteria are required and introduce significant challenges for manufacturers seeking CE Marking and global market access. With updated compliance ...

NEW YORK – Diasorin said Tuesday that it has received CE marking under the EU's In Vitro Diagnostic Regulation for a molecular test to detect the fungal pathogen Candida auris, a common source of ...

MLB, Topps and Nike have partnered to recognize baseball's elite performers from last season with custom gold-embellished MLB logos on their jerseys that will then be used to create trading cards.

From its origins in a garage to becoming one of the most recognisable symbols in the world, explore the story behind the iconic Apple logo design. Apple is a company that has changed the technology ...