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The heart devices in question have been associated with thousands of reports of patients’ injuries and deaths, as described in a KFF Health News investigation late last year. ” said Sanket Dhruva , a cardiologist and an expert in medical device safety and regulation at the University of California-San Francisco.
. “To me this is a safety signal and it’s hard to know if the FDA is working on something to address it,” said Kinard, founder of Device Events , a company that makes FDA device data more user-friendly for hospitals, lawfirms, investors, and others. “The FDA may be missing some signals,” he said.
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