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