Friday October 19, 2018

Anti-epilepsy pill manufactured with 3D printer gets US FDA approval

0
//
46
www.fdalawyersblog.com
Republish
Reprint

Washington: The US Food and Drug Administration has approved the sale of an anti-epilepsy pill manufactured with a three-dimensional (3D) printer.

Photo Credit: www.medscape.com
Photo Credit: www.medscape.com

Aprecia Pharmaceuticals announced that the FDA had approved its Spritam medication for the treatment of epilepsy.

The company said that with its ZipDose 3D printing technology, it is possible to create a detailed, porous structure which allows the pill to dissolve faster while delivering up to 1,000 mg of medication in a single dose.

Aprecia’s Spritam, the first manufactured with 3D printing technology to win FDA approval, will reach the market early in 2016.

Three-dimensional printing technology has lowered costs substantially over the past few years, enabling designers and experts in a range of fields to create complex pieces and tools in record time.

The FDA has approved the commercial distribution of several medical and prosthetic devices created by 3D printers.

Aprecia said the ZipDose technology will improve the administration of medications to children and the elderly.

(IANS/EFE)

Click here for reuse options!
Copyright 2015 NewsGram

Next Story

First Self-Assisted Hearing Aid Approved by The FDA

The FDA reviewed data from clinical studies of 125 patients, showing that outcomes with self-fitting of the device are comparable on average to those with a professional fitting of the same device

0
FDA
An 85-year-old Nepalese man is seen fitted with a hearing aid, in Kathmandu, Nepal, April 12, 2017. VOA

The US Food and Drug Administration (FDA) on Friday allowed the marketing of a new hearing aid device that can amplify sounds for individuals 18 years or older with perceived mild to moderate hearing loss.

It is the first hearing aid approved by the agency that enables users to fit, programme and control the hearing aid on their own, without assistance from a health care provider, Xinhua news agency reported.

FDA
www.fdalawyersblog.com

Hearing loss, permanent or temporary, can be caused by aging, exposure to loud noises, certain medical conditions and other factors. Individuals with permanent hearing loss can use hearing aids to help them hear the speech and sounds.

The Bose Hearing Aid is a user-fitted wireless air conduction hearing aid, according to FDA.

Air conduction hearing aids can capture sound vibrations through one or more microphones and the signal is processed, amplified, and played back through an earphone placed in the ear canal.

FDA
A hearing aid (representative Image). Wikimedia

Patients can adjust the hearing aid through a mobile application on their phone. This technology enables users to fit the hearing aid settings themselves, in real-time and in real-world environments without the assistance of a health care professional.

Also Read: Eat Right Amount of Good Fat to Stay Healthy

The FDA reviewed data from clinical studies of 125 patients, showing that outcomes with self-fitting of the device are comparable on average to those with professional fitting of the same device with respect to the amount of amplification selected, speech in noise testing and overall benefit. (IANS)

Next Story