The company aims to soon launch two tests to aid the treatment of dermatomycosis and is developing other tests for healthcare ...
CMS officials said they have implemented national controls and sought repayment from dozens of healthcare providers and suppliers.
The Amsterdam-based company recently received IVDR certification for other tests including one for phenylketonuria.
The companies have been collaborating on the development of Kryptos' molecular tests, and Osang led Kryptos' $10 million financing round in 2024.
The single-use blood lancing device is intended to produce microliter capillary whole-blood samples and provide an alternative to finger-prick blood draws. It produces a blood volume of up to 600 ul ...
In particular, the cuts could hurt the FDA's efforts to scale up its expertise and review capabilities in emerging areas like digital- and AI-based devices.
The PCR-based point-of-care assays, which return results within 20 minutes, have received regulatory approval from the US Food and Drug Administration earlier this year.
According to the DOJ, a jury found that New York City-based Alexander Baldonado received tens of thousands of dollars in illegal cash kickbacks and bribes in exchange for ordering genetic cancer tests ...
The patent covers methods, systems, compositions, and kits for the multiplexed detection of analytes in a sample.
Following a delisting decision by the Nasdaq Hearings Panel, the firm laid off its workforce and agreed to pay top executives for part-time consulting work.