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First Prosthetic Iris Approved

On May 30, 2018, the Food and Drug Administration announced the approval of the CustomFlex Artificial Iris. According to the FDA, this is the first approved artificial iris. The approval was granted to Clinical Research...more

FDA Approves NorthStar's Tc-99m Generator

The Food and Drug Administration recently announced approval of the RadioGenix™ System, a technetium 99m (Tc-99m) generator. The RadioGenix™ System is developed by NorthStar Medical Radioisotopes, LLC, a nuclear medicine...more

Embrace™ Neonatal MRI Device Gains FDA Clearance

On July 20, 2017, the Food and Drug Administration announced the clearance of “the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU)” to...more

Myriad Genetics Announces an Assay that Identifies Patients for Olaparib Treatment

Salt Lake City-based Myriad Genetics, Inc. announced that its BRACAnalysis CDx® test accurately identifies patients with ovarian cancer for a second-line treatment with olaparib. The announcement came as a result of a...more

GSK and Verily Partnering to Form New Bioelectronic Medicine Firm

GlaxoSmithKline (GSK) announced that it is partnering with Verily Life Sciences LLC to form Galvani Bioelectronics. According to the press release, GSK and Verily will contribute IP rights and an investment of $712.7 million...more

RoundTable to Acquire Symmetry Surgical for $143 Million

Lake Forest, Illinois-based RoundTable Healthcare Partners recently announced an agreement to acquire Symmetry Surgical, Inc. RoundTable states that the acquisition will provide a new platform in surgical instrumentation and...more

5/10/2016  /  Acquisitions , Medical Devices

FDA Approves the First Insulin Pump and Glucose Monitoring System for Children

West Chester, Pennsylvania-based Animas Corporation recently announced FDA approval for the use of the Animas®Vibe® Insulin Pump and Continuous Glucose Monitoring (CGM) System for children and adolescents, ages two to...more

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