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Tag: FDA

Cancer Diagnosis and Treatment / Medical Devices

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 …

Medical Devices

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, …

Pharmaceuticals / Startups

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 …

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