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Philips issued an update on the status of the June 14, 2021 recall of its Philips Respironics’ continuous positive airway pressure (CPAP), bi-level positive airway pressure (BiPAP) and ventilator devices, citing ozone cleaning as a possible contributor to the problem. Read More
Australia-based CardieX and its manufacturing partner Andon have filed a 510(k) premarket submission with the FDA for the CONNEQT Pulse, the world’s first dual blood pressure and arterial health monitor. Read More
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