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If the ventilator is running on battery power only when the battery fails, ventilation could stop completely, preventing the patient from receiving oxygen and breathing support, the FDA says. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced that it is planning new device regulations aimed at improving patient safety and encouraging innovation. Read More
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