medical device guru

Diagnostics & Healthcare News
First Medical Device Treatment for Childhood ADHD Cleared by FDA
NeuroSigma won de novo clearance from the FDA last week to put the first medical device for treating attention-deficit hyperactivity disorder on the U.S. market. Los Angeles-based NeuroSigma makes the Monarch eTNS system, which is designed to deliver mild electrical signals through a...
April 22, 2019
Diagnostics & Healthcare News
Elucent Medical Wins FDA Clearance for New Breast Surgery Navigation System
Elucent Medical, a company dedicated to developing better pathways for breast cancer care, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the clinical use of the company’s EnVisio™ Surgical Navigation System. Placed at...
April 15, 2019
Diagnostics & Healthcare News
First-Ever Clinical Trial Initiated for Neural Interface that Turns Thoughts into Speech
Synchron, Inc. today announced the initiation of the first clinical trial for the Stentrode™, a minimally-invasive neural interface technology being investigated for restoration of communication in people with severe paralysis. The trial will evaluate the safety of Thought-to-Text™ technology in patients, by assessing...
April 9, 2019
Diagnostics & Healthcare News
Itamar Medical Launches Next-Generation WatchPAT System for Home Sleep Apnea Testing
Itamar Medical Ltd., a company that develops, manufactures and markets non-invasive diagnostic medical devices for sleep apnea with a focus on the cardiology market, today announced the launch of WatchPAT 300, the next generation WatchPAT system for home sleep apnea...
March 27, 2019
Diagnostics & Healthcare News
FDA Breaks Record for Medical Device Approvals in 2018
It’s an unprecedented time for innovation and regulation in medical devices. The Food and Drug Administration announced that 2018 was their most successful year in approving medical devices. 106 devices received the FDA’s marketing green light, breaking the record of...
January 30, 2019
Diagnostics & Healthcare News
1 in 3 GoFundMe Campaigns are for Medical Bills and That’s a Problem Says GoFundMe CEO
Scrolling through the GoFundMe website reveals seemingly an endless number of people who need help or community support. A common theme: the cost of health care. It didn’t start out this way. Back in 2010, when the crowdfunding website began,...
January 17, 2019
Diagnostics & Healthcare News
Teva’s Digital Inhaler Now FDA Cleared
Jerusalem-based Teva Pharmaceuticals’ sensor-packed, app-connected digital inhaler has recently received marketing approval from the US FDA, according to a release from the company. The device will first become available next year through a “small number” of healthcare system pilot partnerships,...
January 2, 2019
Diagnostics & Healthcare News
Boston Scientific Exercises Option to Buy Millipede for $325M
Nearly a year after bagging the option to acquire Millipede, Boston Scientific has pulled the trigger. When the pair inked the agreement in January, Boston Scientific handed over $90 million for a portion of the mitral regurgitation startup’s shares. Now,...
December 28, 2018
Diagnostics & Healthcare News
Acorda’s Inhaled Parkinson’s Therapy Device Wins FDA Nod
Acorda Therapeutics said this week that the FDA approved its Inbrija device for the intermittent treatment of  “off” episodes in people with Parkinson’s disease. The self-administered, inhaled therapy is designed for people experiencing a re-emergence of Parkinson’s symptoms. These “off” episodes...
December 26, 2018
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