Endra meets with FDA on liver disease treatment device
ANN ARBOR–Officials at Endra Life Sciences Inc. (NASDAQ: NDRA) developers of a novel ultrasound device to tret some forms of liver disease, announced that they had what they described as …
Delphinus wins FDA approval for breast ultrasound exam system
NOVI—Officials at Delphinus Medical Technologies Inc. announced that the U.S. Food and Drug Administration has granted premarket approval of its SoftVue 3D Whole Breast Ultrasound Tomography System. The system is …
Stryker gets FDA OK for expanded use of brain stent
KALAMAZOO—Officials at Stryker Corp., the Kalamazoo medical device maker, announced the company has received U.S. Food and Drug Administration approval for an expanded indication of its Neuroform Atlas Stent System, …
Esperion wins FDA approval for new cholesterol-buster, Nexletol
ANN ARBOR—Esperion Therapeutics Inc. (NASDAQ:ESPR) announced that the U.S. Food and Drug Administration (FDA) approved Nexletol (bempedoic acid) tablet, an oral, once-daily, non-statin cholesterol-lowering medicine. Nexletol is indicated as an …