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GI Dynamics updates on Australian market removal, release of Q4 earnings
GI Dynamics (ASX:GID) today updated on the status of its EndoBarrier device in Australia, saying it has no plans to appeal in the country. The company also said it is in talks with the FDA as it seeks...
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Sunshine Heart raises $3.8m
Sunshine Heart (NSDQ:SSH) said today it raised $3.8 million in a new offering with a “healthcare dedicated institutional investor” to support its Aquadex product line. The Eden Prairie, Minn.-based...
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Abiomed launches quality assurance program for Impella heart pump
Abiomed (NSDQ:ABMD) said today it launched the Impella quality assurance program, looking to improve outcomes for cardiogenic shock and protected PCI patients. The Danvers, Mass.-based company said the...
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More deaths tied to Medtronic’s SynchroMed II drug pump
The SynchroMed II implantable drug pump was linked to more than 100 adverse events including 2 previously unreported deaths, Medtronic (NYSE:MDT) said last month. In a letter to doctors published...
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What is the STED format for medical device technical documentation?
By Stewart Eisenhart, Emergo Group EMERGO SUMMARY OF KEY POINTS: Summary Technical Documentation (STED) was developed to drive more standardization of medical device regulatory submissions across...
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What it’s like to be a woman in the corner office: A DeviceTalks podcast
There’s an old saying that Ginger Rogers did everything Fred Astaire did, except she did it backwards and in high heels. For Nancy Briefs, Deborah DiSanzo and Martha Shadan, that’s a reality they know...
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Slippery coating aims to stop biofilm infection on implants
Researchers from the Wyss Institute for Biologically Inspired Engineering at Harvard University created a slippery surface coating that can prevent bacterial infection from developing on medical...
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Report: St. Jude sold off older CRM devices after learning of battery issue
St. Jude Medical (NYSE:STJ) continued to distribute outdated pacemaker devices that were indicated in a recall due to battery faults, even after correcting the flaw and producing new units, according...
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LivaNova shares tumble on CEO exit, Q3 earnings report
LivaNova (NSDQ:LIVN) shares slid nearly 15% today after the company announced the resignation of CEO André-Michel Ballester and released its 3rd quarter earnings. The London-based company said its...
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Inside the largest medical device acquisition in history
In June 2014, Medtronic and Covidien shook the medical technology industry with the announcement of a merger of unprecedented scale. OCTANe’s Medical Investor Forum, held in Irvine, Calif., Oct. 27-28,...
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BriaCell names ex-GSK exec Williams as CEO | Personnel Moves, Nov. 1, 2016
BriaCell Thereapeutics (CVE:BCT) said last week that it named biotechnology veteran Dr. William Williams as its president & CEO effective Nov. 1. The Berkeley, Calif.-based company’s lead product...
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Neuravi raises $16.7m
Neuravi said today it raised $16.7 million (EU €15 million) in a new round of debt financing, with funds slated to support U.S. commercialization and portfolio expansion. Money in the round came from...
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TCT 2016: Structural heart, drug-coated balloons take their turn on Day 3
The annual Transcatheter Cardiovascular Therapeutics conference is under way in Washington, D.C., with late-breaking study results beginning Oct. 29. We’ll update this post throughout the day as new...
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Sernova, CTI ink regulatory deal for Cell Pouch System
Sernova said it inked a regulatory deal with CTI Clinical Trial and Consulting Services to further the clinical development and IND application for its Cell Pouch drug delivery system. The London,...
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Japan approves St. Jude Medical’s EnSite, TactiCath
St. Jude Medical (NYSE:STJ) said today it won Japanese MHLW approval for its EnSite Precision cardiac mapping system and its TactiCath irrigated ablation catheter. The Ensite cardiac mapping system is...
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Cohero raises $9m Series A for smart inhalers
Cohero Health said today that it closed a $9 million Series A round for its BreatheSmart patient monitoring platform, which can track medication adherence and measure lung functioning. The funds are...
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Droplet ‘taxicabs’ transport nanoparticles into cell
Researchers from the University of Massachusetts-Amherst have developed polymer-stabilized droplet carriers that can identify and engulf nanoparticles to bring them into a cell. The team was inspired...
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MassDevice.com +5 | The top 5 medtech stories for November 2, 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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PeerWell raises $2m for ‘prehab’ app for ortho procedures
Healthcare technology developer PeerWell said today it raised $2.1 million in seed funding to support its PreHab hip and knee replacement surgery optimization application. The San Francisco-based...
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Second Sight wins CMS reimbursement codes for Argus II ‘bionic eye’
Second Sight Medical (NSDQ:EYES) said today it won reimbursement coverage from the Centers for Medicare & Medicaid Services for procedures using its Argus II retinal prosthesis system designed to...
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