FDA Approves Device to Treat Severe Chronic Heart Failure

FDA Approves Device to Treat Severe Chronic Heart Failure »

22 Mar, 2019
News
  The U.S. Food and Drug Administration (FDA) has approved Impulse Dynamics’ Optimizer Smart system for delivering cardiac contractility modulation therapy for patients with chronic, moderate-to-severe heart failure who are not suited for treatment with other heart failure devices. The Optimizer Smart system was granted breakthrough device designation in 2015 because it treats heart failure —…
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After Record Year for Medical Device Innovation, FDA Looks Toward Patient Safety

After Record Year for Medical Device Innovation, FDA Looks Toward Patient Safety »

30 Jan, 2019
MedTech FeaturesNews
  In 2018, the U.S. Food and Drug Administration (FDA) approved 106 novel devices, surpassing the 40-year record of 99 set in 2017 and capping eight years of steady improvement, according to remarks from FDA Commissioner Scott Gottlieb, M.D. Going forward, the regulator intends to fight for greater patient safety when it comes to medical…
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How One Company’s Digital Prescription App Will Change Mental Illness Therapy

How One Company’s Digital Prescription App Will Change Mental Illness Therapy »

23 Apr, 2018
Uncategorized

Right now, mental illness is a widespread problem in the U.S. Pear Therapeutics, a Boston-based digital prescription company, plans to solve it—with smartphone apps.

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What the MedTech Act Really Means for Healthcare Innovation

What the MedTech Act Really Means for Healthcare Innovation »

13 Apr, 2015
NewsUncategorized
We outline the pros and cons of the MedTech Act. Will it help grow or crush healthcare innovation? Photo via stasique/ shutterstock. In 2014, Senators Orrin Hatch and Michael Bennett proposed an initiative called the “Medical Electronic Data Technology Enhancement for Consumers' Health Act.” The act focuses on bringing medical innovations…
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#NowTrending: This Week’s MedTech News

#NowTrending: This Week’s MedTech News »

27 Mar, 2015
News
We bring you this week's medtech news, from Boston and beyond: 1. Phoenix Children's Hospital Brings in the Tablets Phoenix Children's Hospital is known to be innovative both in design and practice. Photo via archdaily. According to mobihealthnews, the Arizona-based children's hospital plans to install 200 tablets in patient rooms, each equipped with…
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#NowTrending: This Week’s MedTech News

#NowTrending: This Week’s MedTech News »

20 Mar, 2015
News
We bring you this week's medtech news, from Boston and beyond: 1. Boston Represents at SXSW CareAline founders Kezia and Mike Fitzgerald present their pitch at the Boston Children's Hospital's Innovation Tank pitch off last November. Photo via Boston Children’s Hospital. Voices of the Boston healthcare community rang out loud and clear at…
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#NowTrending: This Week’s MedTech News

#NowTrending: This Week’s MedTech News »

13 Mar, 2015
News
Geneia and Physicians' Alliance Ltd. entered an agreement to introduce advanced analytics in 22 medical practices. Photo courtesy of TechWorld. We bring you this week's medtech news, from Boston and beyond: 1. FDA Launches App to Monitor Drug Shortages The FDA has released an app that will enable physicians to monitor…
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23andMe Wins FDA Approval for New Genetic Test

23andMe Wins FDA Approval for New Genetic Test »

4 Mar, 2015
News
In the past, the FDA has expressed worry that consumers might misinterpret at-home genetic tests, leading to improper decisions without physician guidance. This is why 23andMe was forced table one of their personal genome tests in November 2013. It's been an uphill battle, 23andMe's leaders say. That's also why, when the FDA granted direct-to-consumer marketing rights for 23andMe’s Bloom Syndrome…
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