medical device guru

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
Diagnostics & Healthcare News
False-Positive Mammograms Increase a Woman’s Breast Cancer Risk
Women who experience false-positive mammograms are at an increased risk of breast cancer for more than a decade, according to new research published in the British Journal of Cancer. The authors collected data from more than 1.1 million women from three population-based screening...
December 20, 2018
Diagnostics & Healthcare News
GE Healthcare Secretly Files for IPO
GE Healthcare reportedly filed confidentially for an initial public offering as it readies a spinout of its GE Healthcare business. The Boston-based industrial giant tapped Goldman Sachs, Bank of America, Citigroup, JPMorgan Chase and Morgan Stanley for help with the...
December 19, 2018
Diagnostics & Healthcare News
Itamar Medical Reports Record Third Quarter Results
Itamar Medical, a company that develops, manufactures, and markets non-invasive diagnostic medical devices for sleep apnea with a focus on the cardiology market, today reported financial results for the third quarter of 2018. “We are pleased with the solid increase...
November 28, 2018
Diagnostics & Healthcare News
FDA Releases Plan to Modernize the 510(k) Pathway
The FDA today released plans for updating its 510(k) clearance pathway, including a push to move away from using predicate devices over 10 years old and the creation of a new alternative 510(k) pathway that will allow approval based on...
November 27, 2018
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