CBO's recent score tallied temporary PAMA delay as a cost rather than a savings, potentially making future delays less likely ...
NEW YORK — Becton Dickinson said on Monday that its partner Certest Biotec has received In Vitro Diagnostic Medical Device Regulation certifications in Europe for two infectious disease assays.
Launched less than three years ago, the system may be changing how point-of-care tests are used in doctor's offices and emergency rooms.
NEW YORK – An investor holding stake in OraSure Technologies, Altai Capital Management, announced Wednesday that it intends to nominate two candidates to OraSure's board of directors, hinting at a ...
Launched less than three years ago, the system may be changing how point-of-care tests are used in doctor's offices and emergency rooms.
The goal of the proposal is to "streamline and future-proof" the IVDR, particularly to relieve the burden on small- and medium-sized enterprises.
Protavio is leading the development of the IVD-grade test kit, while Repado is developing the test's analysis software.
The man unlawfully billed Medicare for hundreds of millions of dollars as part of a cancer genetics and cardiovascular genetics testing scheme, according to the DOJ.
Should the €6.3 million effort prove successful, it could lead to the adoption of Volition's assay for routine clinical use across France.
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