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FDA Eyes Tailored Approach to Regulating AI-Based Medical Devices
FDA Commissioner Scott Gottlieb is making the most of his final week at the agency. In the month that has passed since Gottlieb rattled the medical device industry with news of his impending resignation, the commissioner has issued 18 public statements pertaining to nearly all corners of the agency's realm, from food, tobacco, and cosmetics to drugs and devices. Friday is Gottlieb's last day on the job. On Tuesday, Gottlieb said the agency will consider a new regulatory framework for reviewing medical devices that use advanced artificial intelligence algorithms. AI has been making headlines in medtech for a whi...
Source: MDDI - April 3, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Software Source Type: news

Can You Think Yourself Into A Different Person?
For years she had tried to be the perfect wife and mother but now, divorced, with two sons, having gone through another break-up and in despair about her future, she felt as if she’d failed at it all, and she was tired of it. On 6 June 2007 Debbie Hampton, of Greensboro, North Carolina, took an overdose of more than 90 pills – a combination of ten different prescription drugs, some of which she’d stolen from a neighbor’s bedside cabinet. That afternoon, she’d written a note on her computer: “I’ve screwed up this life so bad that there is no place here for me and nothing I can contr...
Source: Science - The Huffington Post - November 19, 2015 Category: Science Source Type: news

McGuire to take reins at Second Sight, Greenberg heads board | Personnel Moves
Second Sight Medical‘s (NSDQ:EYES) newly appointed CEO Will McGuire is set to take the reins starting August 18, the company said. Announced in June, former CEO Dr. Robert Greenberg will become chairman of the board at Second Sight, replacing Alfred Mann who will become chairman emeritus, according to the Sylmar, Calif.-based ‘bionic eye’-developing company. “Will brings an immense depth of experience in the life sciences industry that will advance Second Sight’s commercialization of the Argus II retinal prosthesis. After a thorough search process, management and the board of directors are con...
Source: Mass Device - August 13, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Invuity Monteris Medical Personnel Moves Second Sight Medical Products Inc. Volcano Corp. Source Type: news