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Spindiag also received a CE-IVD certification for its test for methicillin-resistant Staphylococcus aureus (MRSA), which causes hard-to-treat infections in humans. Read More
The test can be used for qualitative detection of nucleic acid from the SARS-CoV-2 coronavirus from nasal swab samples from individuals suspected by their healthcare provider of being infected with COVID-19. Read More
Wound Care Technologies, a provider of wound therapy systems, received a Form 483 from the FDA for inadequate inspection procedures for incoming products, as well as for its handling of complaints and medical device reporting (MDR). Read More
The FDA hit Heany Industries, a manufacturer of industrial ceramics and thermally based coatings, with a Form 483 for inadequate validations and corrective and preventive action (CAPA) procedures after an inspection of its Scottsville, N.Y., facility in March. Read More
Endologix said it is preparing to submit its Detour percutaneous bypass system for the FDA’s premarket approval, following the successful outcome of a pivotal study. Read More