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Diagnostics & Healthcare News
World’s First Long-Term Implantable Glucose Monitoring Device Now FDA Approved
GERMANTOWN, Md., June 21, 2018 — Senseonics Holdings, Inc. (NYSE American: SENS) today announced the U.S. Food and Drug Administration has approved its Pre-market Approval (PMA) application to market the company’s Eversense® Continuous Glucose Monitoring (CGM) System to people with diabetes...
June 22, 2018
Diagnostics & Healthcare News
GE Booted From the Dow After More Than 100 Years
For the first time in 110 years, General Electric will not be a member of the elite Dow Jones Industrial Average. S&P Dow Jones Indices announced on Tuesday that the iconic maker of light bulbs and jet engines will be...
June 20, 2018
Diagnostics & Healthcare News
Boston Scientific Will Not Comment on Reported Stryker Takeover Offer
Boston Scientific said Monday it won’t comment on reports rival medical device manufacturer Stryker made a takeover bid, which was first reported by The Wall Street Journal. Stryker’s shares tumbled more than 4 percent, and Boston Scientific’s rose nearly 8 percent Monday in...
June 12, 2018
Diagnostics & Healthcare News
Stryker Makes Takeover Approach to Boston Scientific
Boston Scientific shares rose nearly 7 percent Monday after the Wall Street Journal reported rival medical device manufacturer Stryker approached it with a takeover bid. A deal would combine two medical device giants into a powerhouse with a combined value of more than...
June 11, 2018
Diagnostics & Healthcare News
5 new deaths from liquid-filled intragastric balloons prompt FDA warning
The FDA today released a notice warning of five new patient deaths related to two liquid-filled intragastric balloon systems used to treat obesity, produced by Apollo Endosurgery (NSDQ:APEN) and ReShape Lifesciences (NSDQ:RSLS). The additional deaths bring the total number of deaths worldwide from the...
June 5, 2018
Diagnostics & Healthcare News
Layoffs at IBM Watson Health Spark Concerns
IBM has laid off approximately 50 to 70 percent of staff this week in its Watson Health division, according to inside sources. The axe, we’re told, is largely falling on IBMers within companies the IT goliath has taken over in...
May 31, 2018
Diagnostics & Healthcare News
FDA Permits Marketing of First Autonomous Artificial Intelligence-Based Medical Device
On April 11, 2018, the U.S. Food and Drug Administration (“FDA”) permitted marketing of the first device to use artificial intelligence (“AI”) autonomously to detect a medical condition. The device, called IDx-DR, utilizes an AI algorithm to screen for diabetic...
May 23, 2018
Diagnostics & Healthcare News
Medical Device Companies Could Be Hurt By Chinese Tariffs
US medtech firms, including GE Healthcare (NYSE:GE) and the thriving Minnesota-based medtech sector, are concerned that tariffs on Chinese products proposed by President Trump could significantly affect their business, according to two reports released this week. GE Healthcare executives are worried that...
May 15, 2018
Diagnostics & Healthcare News
FDA Demands Medical Devices to up their Security!
  The US Food & Drug Administration plans to ask Congress for more funding and regulatory powers to improve its approach towards medical device safety, including on the cybersecurity front. An FDA document released this week reveals several of the...
April 20, 2018
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