clearance from the US Food and Drug Administration (FDA) for the E1000 Dx, a digital pathology workflow solution for streamlining laboratory cancer diagnostics. Available in Europe as an in vitro ...

has announced a registered direct offering and concurrent private placement that is expected to generate $29.1 million in gross proceeds, primarily to support the development of its FDA IVD ...

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority ...

Sidebar: In Vitro Diagnostics (IVD) industry -- more information Manufacturers of devices that test fluids or tissues outside the body say the agency's excessively high standard hinders innovation.

The round is expected to generate $29.1 million, which will be used primarily to fund the company's FDA In-Vitro Diagnostic (IVD) transplant assay program through clearance and commercial launch.

Combined with Oncocyte's current cash on hand, the offering proceeds are expected to fully fund the development of the Company's FDA In-Vitro Diagnostic (IVD) transplant assay program. FDA clearance ...

The platform includes solutions that are CE-IVD certified (per IVDR framework) and registered with the UK MHRA, TGA in Australia and ANVISA in Brazil. Ibex Prostate Detect is FDA cleared and other ...

DCN Dx, specializing in IVD CDMO and CRO services, has launched Regulatory Affairs Services, a new solution designed to help clients navigate complex regulatory pathways efficiently and successfully.

The new offering provides comprehensive support for FDA and international regulatory ... to the unique needs of in vitro diagnostic (IVD) developers and manufacturers. This expansion complements ...