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More than half of internet-connected medical devices in hospitals “have a known critical vulnerability,” but intravenous (IV) pumps are at the top of the list, says health tech company Cynerio. Read More
If the chemical breakdown occurs, it may cause serious harm to patients, including irritation of the respiratory tract and lung swelling caused by excess fluid, the FDA said. Read More
The agency is working with Endologix to identify patients who may benefit from treatment with the AFX2 device, updating labeling and gathering long-term safety data. Read More
To date, Philips Respironics has produced approximately 1.5 million repair kits and replacement devices, of which approximately 700,000 have reached customers. Read More
The company noted that the performance of all rapid antigen tests has come under scrutiny in light of the large number of mutations in the Omicron variant. Read More
If the graphical biopsy depth gauge is no longer synchronized with other navigation views during neurosurgery, it may result in “tissue injury, including potential for life-threatening injury,” the FDA said. Read More
The review was triggered by Philips’ international recall of its ventilators, CPAP and BiPAP devices due to risks posed by the soundproofing material. Read More