News

The court case related to the FDA’s ‘Final Rule.’ Issued in May 2024, it asserted that IVDs were medical devices and would ...
The FDA’s new guidance document on informed consent for IVD studies using leftover human specimens will positively impact industry with regards to facilitating the development of new technologies.
The global Medical Device Contract Manufacturing Market, valued at US$78.58 billion in 2024, stood at US$83.77 billion in ...
Known IVD devices can read lateral flow assay strips to detect the existence of a hormone, metabolite, toxin, or pathogen-derived antigen.
Seegene Receives CE-IVD Mark for Use of Combo Swab, a Self-Collection Device with Four COVID-19 Diagnostic Tests ...
The Central Drugs Standard Control Organisation (CDSCO), India’s top drug regulatory body, has released draft protocols for the approval of In-Vitro Diagnostic (IVD) devices used in the detection of ...