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. Cordis recalls Precise Pro RX carotid stent over separation issues
Cardinal Health subsidiary Cordis recently revealed a voluntary recall of its Precise Pro RX nitinol carotid stent system based on issues with shaft separation during stent deployment.
The issue was discovered after the company received complaints about separation difficulties with the stent, which is indicated for use in patients with stenotic lesions of the carotid artery, and investigated the issue independently. Read more
4. SV Life Sciences’ 6th fund pulls in $274m
SV Life Sciences said it raised $274 million of the $400 million it hopes to put into its 6th fund for investing in healthcare companies.
The Boston-based venture capital shop said in a regulatory filing that 24 unnamed investors participated in the round, which began in May 2015. Read more
3. Intuitive Surgical warns on embolism risk with da Vinci Xi in heart procedures
Intuitive Surgical today warned of the risk that small particulates could be introduced inside the heart during intra-cardiac procedures using its da Vinci Xi device.
Sunnyvale, Calif.-based Intuitive said it hasn’t received any reports of injuries related to the high-density polyethylene particles it turned up during quality inspections of its 5mm-8mm universal seal or the 12mm & stapler universal seal used with the da Vinci Xi. Intuitive said the particulate was found in the insufflation stopcocks used with the seals. Read more
2. Diabetes: FDA panel to mull expanded indication for Dexcom G5 continuous glucose monitor
The FDA said it’s planning to convene an advisory panel in July to consider expanding the indication for the G5 mobile continuous glucose monitor made by Dexcom.
The Center for Devices & Radiological Health’s chemistry & toxicology panel is slated to meet July 21 to recommend whether the intended use for the Dexcom G5 should be changed so that diabetics can use it to replace finger-stick blood glucose monitoring; the G5 device measures glucose using the interstitial fluid surrounding cells just under the skin. Read more
1. Medtronic’s Q4, 2016 numbers top Wall Street
Medtronic today reported fiscal year-end results that topped both sales and earnings estimates on Wall Street, sending share prices up a tick this morning.
The world’s largest pure-play medical device maker said it swung to Q4 black for the 3 months ended April 29, after putting up a -$1 million loss during the same period last year. Profits for Q4 2016 were $1.10 billion, or 78¢ per share, on sales growth of 3.6% to $7.57 billion compared with Q4 2015. Read more
