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Reduced gas flow may occur when a patient is already under anesthesia, causing a buildup of carbon dioxide in the patient’s body, the agency said. Read More
The false positive results may be linked to the polymerase chain-reaction mixture slopping over from positive samples into negative samples, the agency said. Read More
The reason for the recall is a risk of the delivery system’s wire and tubes fracturing and breaking off when the system is being used to place, retrieve or move the stent. Read More
As of Aug. 31, there had been at least 66 infections, including 60 bloodstream infections, associated with these affected products, the agency said. Read More
In combination with medical alert systems that respond to emergencies, “technology and ease of use for customers are key to the future of the connected health industry," said Andy Droney, senior director of health and innovation programs at the home security company ADT. Read More
The affected kits “could potentially underestimate blood lead levels when processing patient blood samples,” said Meridian Bioscience, Magellan’s parent company. Read More
The agency reviewed the company’s websites on June 21 and found that the products were still being marketed without FDA approval, clearance or authorization. Read More
The agency has only cleared robotically assisted surgical devices for certain types of cancer surgeries, such as hysterectomies, prostatectomies and colectomies, provided there is 30-day patient follow-up. Read More