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. CSP Technologies expands Alabama facility
CSP Technologies is expanding its Auburn, Ala. manufacturing and warehousing capacity by 110,000 sq. ft. The expansion has already begun and is under construction.
The company said in a recent news release that it is expanding its facility because of the growing needs of the healthcare and food safety industries. The expansion follows a thermoforming line that was released earlier this year. Read more
4. Vascular Dynamics touts significant BP reductions in interim MobiusHD trial results
Vascular Dynamics yesterday released interim results from the 1st-in-human trial of its MobiusHD implant designed for treating resistant hypertension, touting significant reductions in ambulatory systolic blood pressure.
Results were released at the European Society of Cardiology’s annual meeting in Barcelona. Read more
3. Most FDA user fees set to rise 33%
The latest user fee authorization enacted last week has most of the fees medical device makers pay the FDA to review its products rising by more than 33%, with the fee for one popular protocol jumping more than 125%.
All but one of the user fees for fiscal 2018, which begins Oct. 1, are going up 32.5% compared with the fiscal 2017 fees for both small businesses making less that $100 million annually and for their larger brethren, according to the FDA’s Center for Devices & Radiological Health. Read more
2. Abbott upgrades St. Jude Medical cardiac devices
Abbott said today that it’s upgrading the implantable pacemakers and defibrillators it acquired when it paid $25 billion for St. Jude Medical earlier this year, seeking to move beyond battery and cybersecurity issues that haver plagued it for a year.
Last October St. Jude warned of a battery issue that could disable its high-voltage cardiac rhythm management devices, saying the problem was associated with 2 deaths among the nearly 400,000 patients implanted with affected devices. The issue stemmed from the formation of lithium clusters in the lithium-based batteries used in the devices that can form during high-voltage charging. The clusters could then cause a short circuit and deplete the battery within a day to a few weeks, rendering the device incapable of delivering therapy. Read more
1. Medtronic puts another $40m into Mazor Robotics
Mazor Robotics said today that it’s accelerating a deal with Medtronic, which is due to put another $40 million into Mazor and take on exclusive global distribution rights for the Mazor X robot-assisted surgery device.
It’s the third investment in the Israeli surgical robotics concern for Fridley, Minn.-based Medtronic, taking its total investment to $72 million and a 10.6% stake in Mazor. The deal also includes 1.21 million warrants priced at $44.23 apiece; if exercised in full Medtronic would own a 14.2% stake in Mazor, having invested some $125 million. Read more
The post MassDevice.com +5 | The top 5 medtech stories for August 30, 2017 appeared first on MassDevice.
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