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FDA Regulations

The Absorb GT1 Bioresorbable Vascular Scaffold (GT1 BVS) System is a fully absorbable stent   mounted on a balloon dilatation catheter...

It is a heart pacing therapy system for patients with slow heart rates, or irregular heart rhythms. It creates electrical pulses...

Medtronic has started to inform patients worldwide of a voluntary recall of infusion sets used with all models of Medtronic insulin pumps...

Ventana PD-L1 (SP142) assay approved by FDA in 2016, is a laboratory test for PD-L1 status assessment in bladder cancer...

A cochlear implant is an implanted electronic hearing device, designed to produce useful hearing sensations to a person with...

Dermal fillers, also known as injectable implants, soft tissue fillers, approved by the Food and Drug Administration (FDA) for...

Ventana PD-L1 (SP142) assay approved by FDA in 2016, is a laboratory test for PD-L1 status assessment in bladder cancer...

The Dexcom G5 Mobile Continuous Glucose Monitoring System (Dexcom G5) consists of an externally-worn glucose sensor...

The U.S. Food and Drug Administration today approved Mavyret (glecaprevir and pibrentasvir) to treat adults with...

The DigniCap Cooling System is indicated to reduce the frequency and severity of hair loss during chemotherapy in solid tumor cancer...

granted emergency use authorization to Thermo Fisher Scientific's TaqPath Zika Virus Kit.The kit is authorized to be conducted by...

Kymriah, a cell-based gene therapy, is approved in the United States for the treatment of patients up to 25 years of age with B-cell precursor...

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