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Judge: Doc can’t drag Globus into patent spat with Medtronic
A doctor suing Medtronic (NYSE:MDT) for allegedly infringing his patents covering spinal deformity repair devices can’t drag Globus Medical (NYSE:GMED) into the dispute, a federal judge in Pennsylvania...
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Cardiovascular Systems to settle lawsuit for $8m
Cardiovascular Systems (NSDQ:CSII) said today that it agreed to an $8 million settlement with the plaintiff in a False Claims Act lawsuit based on allegations from a former sales rep that the company...
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Medinol launches trial for NIRxcell stent
Medinol said it enrolled the 1st U.S. patient in a post-market study of its bare-metal NIRxcell stent, which has been on the U.S. market since January 2015. Tel Aviv-based Medinol said the NIRxcell...
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B. Braun, ICU Medical ink long-term distro deal
ICU Medical (NSDQ:ICUI) said today it inked a long-term distribution deal with B. Braun Medical for ICU’s SwabCap disinfecting cap for needlefree connectors for select countries outside the U.S. San...
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Senate bill would streamline FDA’s medical device reviews
A bipartisan duo in the U.S. Senate introduced a bill last week that aims to streamline the way the FDA reviews medical devices. Sens. Amy Klobuchar (D-Minn.) and Pat Roberts (R-Kan.) introduced...
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FDA weighs dangers of faulty readings from blood clot monitors
The FDA is considering possible dangers from medical devices that monitor blood clotting producing false readings, according to a report from The Wall Street Journal. The FDA has tracked thousands of...
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Repro-Med updates on FDA warning letter over Freedom Infusion sets
Repro-Med Systems last Friday updated on a warning letter it received in February over issues the FDA found with the company’s Freedom 60 syringe infusion pump and Freedom Edge infusion pumps. The...
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MassDevice.com’s Personnel Moves | March 21, 2015
AdvaMed taps Cohera CEO Daly for Accel chairmanship AdvaMed said it tapped Patrick Daly, president & CEO of Cohera Medical, to be the new chairman of its AdvaMed Accel division for smaller medical...
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FDA proposes ban on powdered medical gloves
The FDA today unveiled a proposal to ban most powdered medical gloves in the U.S. The agency said that while the use of such gloves is decreasing, they still pose an unreasonable and substantial risk...
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MassDevice.com +5 | The top 5 medtech stories for March 21, 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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LifeWatch loses $19m decision to Highmark Blue Cross Blue Shield
LifeWatch (SWX:LIFE) said today that an arbitrator from the Interanational Centre for Dispute Resolution ruled against the firm and in favor of Highmark Blue Cross Blue Shield to the tune of $18.7...
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Malaysian advertising rules for medical devices published
By Stewart Eisenhart, Emergo Group The Malaysian Medical Device Authority (MDA) has issued draft requirements for how to properly market and advertise medical devices in the country. The MDA draft code...
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Abiomed, FDA come to terms on Impella PMA requirements
Abiomed (NSDQ:ABMD) said yesterday that it came to terms with the FDA over the indications for use for its Impella line of cardiac assist devices and doesn’t believe it will have to appear before 1 of...
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Acutus Medical closes $75m Series C round for 3D cardiac mapping tech
Acutus Medical said today that it closed a Series C funding round worth $75 million for the AcQMap 3D cardiac mapping technology it’s developing – including a contribution from an unnamed strategic...
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Medtronic to shift product lines from Colorado plant
Medtronic (NYSE:MDT) is planning to move a pair of product lines from a plant in Colorado to other facilities, a spokesman told MassDevice.com today. Fridley, Minn.-based Medtronic acquired the lines...
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Boston Scientific launches Axios stent and delivery system
Boston Scientific (NYSE:BSX) said today that it launched the Axios stent and electrocautery delivery system it obtained through the $62.5 million buyout of Xlumena last year. The newly cleared Axios...
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DeviceTalks Podcast: Cohera Medical CEO Patrick Daly
Before Patrick Daly was tapped as chairman of AdvaMed’s Accel unit, which represents emerging medical device companies, the CEO of Cohera Medical sat down with MassDevice.com Executive Editor Brad...
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Titan Medical prices offering to support Sport robot system
Titan Medical (CVE:TMD) said today it priced a previously announced offering, planning to offer an unspecified number of shares priced at 77¢ (CDN $1) per unit, with each unit comprised of a common...
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In Vitro Diagnostics – The Basics
It has been estimated that In Vitro Diagnostics (IVD) will play a role in around 70% of health care decisions, and market estimates predict the IVD market will be close to 75 billion dollars in 2010....
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Aerin Medical closes $16.7 Series C
Nasal airflow device developer Aerin Medical said today it closed a $16.7 million Series C financing round which it operated in 2 separate stages. The company said an initial closing of $6.1 million...
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