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[1] [2] It has been gaining popularity over the last few decades and was approved in Europe in 2013 and the Food and Drug Administration (FDA) in April 2014. [3] The purpose of the hypoglossal nerve stimulator is to relieve tongue base obstruction during sleep by stimulating the tongue to protrude during inspiration (i.e., inhale). [1]
The device, called Portable Neuromodulation Stimulator (PoNS), is a neuromuscular tongue stimulator that consists of a non-implantable apparatus to generate electrical pulses for stimulation of the trigeminal and facial nerves via the tongue to provide treatment of motor deficits. [125]
Modern cochlear implant research started in the 1960s and 1970s. In 1961, a crude single electrode device was implanted in two deaf patients and useful hearing with electric stimulation was reported. The first FDA approved complete single channel device was released in 1984. [25]
BrainPort is a technology whereby sensory information can be sent to one's brain through an electrode array which sits atop the tongue. [1] It was initially developed by Paul Bach-y-Rita as an aid to people's sense of balance, particularly of stroke victims. Bach-y-Rita founded Wicab in 1998. [2] [3] [4]
In 2004, a pulsed electromagnetic field system was approved by the FDA as an adjunct to cervical fusion surgery in patients at high risk for non-fusion. [6] On 8/9 September 2020 the FDA recommended to shift PEMF medical devices from the Class 3 category to a Class 2 status. [7]
The injectable drug, branded as Maxigesic IV, was approved as a post-operative drug in hospitals or when patients cannot take medicine orally. Maxigesic IV, a combination of paracetamol with ...
The MDA established a risk-based framework for the classification of medical devices and a regulatory pathway for medical devices to get to the market, created a regulatory pathway for medical device clinical trials, and established several post-market requirements including manufacturer registration and device listing with the FDA, good ...
In 2010, guanfacine was approved by the FDA for the treatment of attention deficit hyperactivity disorder for people 6 to 17 years old. [16] It was approved for ADHD by the European Medicines Agency under the name Intuniv in 2015. [61] It was added to the Australian Pharmaceutical Benefits Scheme for the treatment of ADHD in 2018. [62]