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Home » MassDevice.com +5 | The top 5 medtech stories for July 18, 2017

MassDevice.com +5 | The top 5 medtech stories for July 18, 2017

July 18, 2017 By MassDevice

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Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

Get this in your inbox everyday by subscribing to our newsletters.

 

5. FDA grants regenerative medicine advanced therapy status to Mallinckrodt’s StrataGraft

MassDevice.com news

Mallinckrodt Pharmaceuticals said today that its StrataGraft regenerative skin tissue won regenerative medicine advanced therapy status from the FDA.

The tissue-based therapy is among the first products to be granted the designation. The 21st Century Cures Act, which was passed in 2016, enabled the FDA to give accelerated review approval to products that meet RMAT criteria. Read more


4. T2 Biosystems wins CE Mark for MR-based bacteria detector, closing in on FDA bid

MassDevice.com news

T2 Biosystems Inc. said today it won CE Mark approval in the European Union for its T2Bacteria Panel magnetic resonance-based bacterial detector, and said that it has entered the final stages of its FDA pivotal trial as it seeks 510(k) approval from the agency.

The T2Bacteria Panel is designed to run on the company’s T2Dx instrument, a miniaturized MR diagnostic device, to provide species-specific test results of targeted bacterial infections in approximately 3.5 hours, the Lexington, Mass.-based company said. Read more


3. Trumpcare foundering, GOP kicks the can past the 2018 mid-terms

MassDevice.com news

The latest version of the Republican plan for healthcare reform foundered last night after two more GOP senators said they would not back the measure, making it impossible for majority leader Sen. Mitch McConnell (R-Ky.) to muster enough votes for passage.

Late last night McConnell said Republicans would instead take up legislation to repeal Obamacare on a two-year delay, kicking the can down the road on healthcare reform until after the 2018 mid-term elections. That idea was rejected by Republicans months ago, to avoid chaos in insurance markets, in favor of simultaneously repealing and replacing Obamacare. Read more


2. Medtronic reiterates FY2018, Q1 outlook

MassDevice.com news

Medtronic today reiterated its previous full fiscal year guidance in light of an information technology system malfunction in June, saying that the disruption along with other circumstances have moved their 4-5% growth rate to the lower end of the range for their fiscal 1st quarter.

Yesterday, Fridley, Minn.-based Medtronic saw shares drop nearly 3% after CFO Karen Parkhill spoke to Bloomberg News about the IT disruptions and their effect on the medtech giant’s upcoming fiscal 1st quarter earnings. Read more


1. Johnson & Johnson’s medical device sales set the Q2 pace

MassDevice.com news

The medical device business at Johnson & Johnson, the world’s second-largest medtech operation, today posted the highest second-quarter sales growth of its three major divisions, outpacing its pharmaceutical and consumer products segments.

The New Brunswick, N.J.-based healthcare titan said its medtech biz posted sales of $6.73 billion for the three months ended June 30, up 4.9% over the same period last year. Read more

Filed Under: News Well Tagged With: Plus 5

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  • Avenda wins FDA IDE nod for AI-enabled prostate cancer therapy
  • NuVasive chief commercial officer Massimo Calafiore is stepping down
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  • Dentsply Sirona replaces chief accounting officer amid internal investigation
  • Haemonetics stock rises on Street-beating Q1, raised guidance
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  • Alcon lowers its 2022 forecast amid strong dollar
  • Masimo beats Street in Q2 as healthcare business catches up
  • Senseonics stock is up as it sticks by revenue guidance
  • Butterfly Network asks judge to dismiss Fujifilm Sonosite IP suit
  • Stereotaxis stock down amid cloudy outlook
  • BD, Labcorp collaborate on flow cytometry-based diagnostics
  • NeuroOne submits special FDA 510(k) application for Evo sEEG electrode

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  • FDA reports sterilization challenge progress as EPA takes aim at EtO emissions
    The FDA offered an update on its efforts to make medical device sterilization safer as the EPA identified 23 U.S. facilities where use of ethylene oxide (EtO) presents a risk to communities. The FDA said it is similarly concerned about unsafe EtO emissions and highlighted work with the medical device industry to reduce EtO usage… […]
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    The EPA today identified nearly two dozen U.S. cities where commercial sterilizers using ethylene oxide (EtO) contribute to an elevated cancer risk for residents of surrounding communities. EtO is used on about 20 billion medical devices each year — or about half of all sterile medical devices —  and in some cases it’s the only… […]

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