Labcorp gains FDA approval for companion diagnostic to Pfizer gene therapy; Senseonics gets FDA clearance to pair CGM implant with insulin pumps; FDA defends LDT final rule, while critics fear it upends lab industry; Abbott wins FDA approval for Esprit resorbable scaffold
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The test would determine if patients are eligible for Pfizer’s new hemophilia B treatment by detecting if they have been exposed to a virus that could make the gene therapy less effective.
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The new policy aims to ensure important diagnostics remain available to patients, but some experts caution the increased regulatory burdens could slow access to testing.
Digital health and artificial intelligence are becoming more prominent in the medical device space as the industry embraces newer technologies and treatments. Explore this growth in this Trendline.
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