Tag Archives: Dr Jeffrey Shuren

Powdered medical gloves banned in US

Washington: The US Food and Drug Administration (FDA) has banned the use of powdered medical gloves, used by doctors, in the country with effect from January 18, 2017. The FDA first proposed the ban on March 21, 2016.

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FDA approval expands access to artificial heart valve for inoperable patients

Washington: The US Food and Drug Administration has approved revised labelling for the Sapien Transcatheter Heart Valve (THV), making the device available to an expanded group of patients who have inoperable aortic valve stenosis, a disease of the heart valves that causes narrowing of the aortic valve, restricting blood flow from the heart.

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FDA approves a new silicone gel-filled breast implant

Washington: The US Food and Drug Administration has approved the MemoryShape Breast Implant to increase breast size (augmentation) for use in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. The MemoryShape Breast Implants are manufactured by Mentor Worldwide.

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FDA approves new silicone gel-filled breast implant

Washington: The US Food and Drug Administration has approved the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. Natrelle 410 implants are manufactured by Allergan.

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FDA approves first retinal implant for adults with rare genetic eye disease

Washington: The US Food and Drug Administration has approved the Argus II Retinal Prosthesis System, the first implanted device to treat adult patients with advanced retinitis pigmentosa (RP).

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FDA seeks input on its proposed approach for mobile medical applications

US Food and Drug Administration has sought input on its proposed approach for mobile medical applications that are designed for use on smartphones and other mobile computing devices. According to FDA, the approach encourages the development of new apps, focuses only on a select group of applications specific to medicine or healthcare and will not regulate the sale or general consumer use of smartphones or tablets.

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