You are not logged in to Prodigits. Please register or login. You are not logged in to Prodigits. Please register or login.
Subject: Orion
Replies: 19 Views: 738
bozzalad 14.03.18 - 10:17pm
The Orion is a brain implant for patients with blindness caused by damage to the optic nerve. With the designation, Second Sight qualified for interactive and timely communication with FDA, even before the Sylmar, Calif., company embarked on a clinical trial to study the device in patients. These early interactions resulted in the development of a flexible study design, review team support, and senior management engagement, all of which may allow a sponsor to evaluate complex, innovative technologies more efficiently.
And, when the development and evaluation of a technology or device is more efficient, beneficial medical devices may be able to reach the patients who need them sooner, even though they may be more complex or challenging to study because they are breakthrough products.
* +
bozzalad 14.03.18 - 10:17pm
The Second Sight trial, approved by FDAs Center for Devices and Radiological Health (CDRH), involves five patients at two sites, Baylor College of Medicine and the University of California in Los Angeles. The first patient received the implant on Jan. 30, 2018.
The Orion isnt the only device to take advantage of the Breakthrough program. Since the Cures Act was passed, CDRH has received 94 requests for breakthrough status for devices treating a variety of conditions and granted 54, with patients as the ultimate beneficiaries.
In FDAs Breakthrough Device Program, the interaction among specialists across disciplines representing the sponsor and FDA, could lead to devices that have the potential to change patients lives, without compromising safety or effectiveness.
In short, it shows FDA at its best, committed to patient access and willing to balance benefits and risks in a scientifically robust manner led by compassion and respect for the perspective of patients. * +
4juice 14.03.18 - 10:19pm
Ah * +
sisfreak2017 14.03.18 - 10:21pm
good stuff * +
dodgey 14.03.18 - 10:26pm
I don't give a sh*t 
* +
dodgey 14.03.18 - 10:27pm
I used to have a Ford Orion as one of my first cars, cosworth bonnet, spoiler and alloys 
* +
crail 14.03.18 - 10:29pm
You fu*king loved it didn't you lol * +
ogdenz 14.03.18 - 10:30pm
Sounds good overall but brain implant sounds grim. * +
+ go to page 1-3
+ my page
+ functions
3 search
4 submit a reply
7 last page
+ bookmark
8 General Chat Forum
9 Forum Index
