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Johnson & Johnson wins 5-year, $60m supply DoD contract
Johnson & Johnson (NYSE:JNJ)’s Health Care Systems won a $60 million 5-year contract deal with the U.S. Department of Defense to supply dental and medical equipment. The money comes from a...
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FDA releases updated draft guidance on 510(k) modification submissions
The FDA today released draft guidance providing updated recommendations for manufacturers on when to submit 510(k) applications for modifications to devices currently on the market. The recommendations...
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Viveve lands S. Korea regulatory clearance for Viveve System
Viveve (NSDQ:VIVE) said today it won regulatory approval from the Ministry of Food and Drug Safety in South Korea for its Viveve non-surgical treatment for post-partum laxity of the vaginal introitus....
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Endologix releases Q2, updates on Nellix discussions with FDA
Endologix (NSDQ:ELGX) on Wednesday released 2nd quarter earnings and updated on its discussions with the FDA over its Nellix system for treating abdominal aortic aneurysms, saying the agency is...
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Draeger recalls VentStar Oxylog 3000 pediatric breathing circuits
The FDA today released information on a Class I recall of Draeger Medical‘s VentStar Oxylog 3000 disposable pediatric patient circuits over issues with air leakage. The federal watchdog labeled the...
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InVivo Therapeutics Q2 meets the street, shares stay steady
InVivo Therapeutics (NSDQ:NVIV) shares stayed steady after the company released 2nd quarter earnings that met the street on losses per share. The Cambridge, Mass.-based company reported losses of $5.2...
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MassDevice.com +5 | The top 5 medtech stories for August 5, 2016
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...
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AtriCure shares dip despite Street-beating Q2
AtriCure (NSDQ:ATRC) released 2nd quarter earnings late yesterday that topped the street in losses per share, but still saw shares dip in trading today. The Mason, Ohio-based company reported losses of...
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Mirabilis Medica brings in $5 million
Uterine fibroid-treating device developer Mirabilis Medica raised $5 million in a new round of debt financing, according to an SEC filing posted today. The company’s Mirabilis system is designed to...
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Smith & Nephew closes $350m Truclear sale to Medtronic, launches $300m buyback
Smith & Nephew (NYSE:SNN) said today that it closed the $350 million sale of its gynecology business, including the Truclear hysteroscopy system, to Medtronic (NYSE:MDT). The London-based...
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ANVISA officially extends deadline for IVD and cadastro technical dossier...
By Stewart Eisenhart, Emergo Group Brazil’s medical device regulator ANVISA has announced official extensions for deadlines to file technical dossiers for low-risk cadastro medical devices as well as...
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Sunshine Heart pays $5m for Baxter’s Aquadex
Sunshine Heart (NSDQ:SSH) said today that it agreed to pay about $5 million for the Aquadex fluid filtration device Baxter (NYSE:BAX) acquired when it bought Gambro in 2013. The Aquadex device is...
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Medtronic wins CE Mark for SureTune2 DBS software
Medtronic (NYSE:MDT) said today that it won CE Mark approval in the European Union for the SureTune2 software used with its deep-brain stimulation devices. The software is designed to allow physicians...
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Alere ticks up after reporting delayed 2015 results
Shares in Alere (NYSE:ALR) ticked up today after the diagnostics giant reported its long-delayed financial results ahead of its $6 billion union with Abbott (NYSE:ABT). Alere, which last month cut its...
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Freudenberg Medical lifts Kley to CEO
Freudenberg Medical said today it promoted Dr. Max Kley to chief executive officer, effective August 1. Get the rest of the story at our sister site, Medical Design & Outsourcing The post...
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St. Jude Medical reverses course on covering top execs’ tax tabs
St. Jude Medical (NYSE:STJ) reversed course on a pledge it made earlier this year not to cover some of tax tab its senior executives could incur after its $25 billion merger with Abbott (NYSE:ABT). St....
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Synthes settles; doc, hospital cleared in Norian XR bone cement suit
Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes last week reportedly settled with plaintiffs shortly before a Washington state court jury cleared Dr. Jens Chapman and the University of...
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University of California pays $9m to settle Medtronic InFuse suits
The regents governing the University of California reportedly agreed to pony up $8.5 million to settle a pair of lawsuits brought against a former UCLA spine surgeon who used MDT’s controversial InFuse...
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CyberHeart inks development deal with Japan’s National Cancer Center
Cardiovascular radiosurgery developer CyberHeart said today it inked its 1st development deal to install its CyberHeart system in Tokyo’s National Cancer Center, making it the 1st non-invasive cardiac...
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3 Keys to Maximize Your Investment in Sales Asset Management
By Melyssa Plunkett-Gomez, Sales Executive, Allego In recent years, the Sales Asset Management (SAM) market – Sales Playbooks, Sales Content Management – has exploded. With relatively new entrants like...
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