Tuesday, July 25, 2017
The FDA has been a busy agency these past few months. The second quarter of 2017 has seen a flurry of clearances, many for technologies that continue the trend toward mobile, or even wearable devices. Its been a good period for those with diabetes, sleep disorders and traumatic injury, not to mention those just looking
[ Read More ]The FDA recently granted 510(k) clearance to the first MRI device specifically designed for imaging the neonatal brain and head in the neonatal ICU.“Although we can use traditional MRI scanners to image neonates, taking babies outside the NICU to MRI suites presents great challenges,” Vasum Peiris, MD, MPH, chief medical officer for pediatrics and special
[ Read More ]PHILADELPHIA When doctors saw the report on Bill Ludwigs bone-marrow biopsy, they thought it was a mistake and ordered the test repeated.But the results came back the same: His lethal leukemia had been wiped out by an experimental treatment never used in humans.We were hoping for a little improvement, remembers the 72-year-old retired New Jersey
[ Read More ]If accepted, which is likely, it will be the first gene therapy ever to reach the market. This is the beginning of something big, a doctor said.
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