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Nikkiso enters U.S. dialysis market with DBB-06 device
Nikkiso (TYO:6376) said the medical division of its Nikkiso America business entered the U.S. hemodialysis market with its DBB-06 system, after winning 510(k) clearance from the FDA in March....
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Pulse Biosciences pounds out $20m with IPO
Pulse Biosciences raised $20 million in an initial public offering this week after floating 5 million shares at $4 apiece, for a fully diluted valuation of $51 million. Burlingame, Calif.-based Pulse...
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Medtronic launches new cervical spine platform in the U.S.
Medtronic (NYSE:MDT) said today that it launched its Spine Essentials platform for cervical spine fusions. The offering is aimed at increasing the efficiency of the most common 1- and 2-level fusion...
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B. Braun pays nearly $8m to settle contaminated saline case
B. Braun Medical agreed to pay $7.8 million and agreed to the facts in a non-prosecution agreement to avoid criminal charges that it sold contaminated saline syringes. Bethlehem, Pa.- and Melsungen,...
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MassDevice.com +5 | The top 5 medtech stories for May 19, 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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Jury awards Edwards Lifesciences $70m in CardiAQ Valve spat with Neovasc
A federal jury in Massachusetts yesterday awarded $70 million to Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve Technologies in a patent infringement lawsuit after finding that Neovasc...
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Endo’s AMS claims pelvic mesh plaintiffs scammed into needless explantation...
Endo International (NSDQ:ENDP) subsidiary American Medical Systems Holdings repoortedly accused “a pyramid of businessmen, doctors and lawyers” of convincing women to undergo unnecessary surgeries to...
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Johnson & Johnson’s robotics unit Verb Surgical aims for end-of-year unveiling
Johnson & Johnson (NYSE:JNJ) expects its Verb Surgical robot-assisted surgery business to move from concept to product design by the end of the year, company officials said this week as they...
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Report: Medical device recalls hit 3-year low in Q1
Medical device recalls fell to their lowest point since 2013 during the 1st quarter, according to a report from Stericycle‘s (NSDQ:SRCL) ExpertSolutions business. Both the number of recalled units and...
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Skyline Medical CEO Kornberg steps down, Schwartz takes over as interim |...
Skyline Medical CEO Kornberg steps down, Schwartz takes over as interim chief exec Skyline Medical said earlier this month that prez and CEO Joshua Kornberg was stepped away from his roles at the...
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MassDevice.com +5 | The top 5 medtech stories for May 20, 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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Hospira launches new LifeCare PCA EMR-linked infusion pump
Hospira said yesterday it is launching the LifeCare PCA 7.0 patient-controlled analgesia infusion pump designed for patient pain management. The company is touting the device as the 1st-PCA infusion...
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iVascular wins CE Mark for Luminor 18 DCB
Spanish vascular device company iVascular S.L.U. said today it won CE Mark approval in the European Union for its Luminor 18 drug eluting balloon designed for lower limb angioplasty. The Luminor 18 is...
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Apollo taps Zillion for Orbera patient app
Apollo Endosurgery said it picked software application platform developer Zillion to support its Orbera Coach program, which is designed to provide virtual aftercare support for patients undergoing...
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FDA warns Eclipse Aesthetics on MicroPen personal dermabrasion device
The FDA recently released a warning letter it sent to Eclipse Aesthetics, claiming the company lacks appropriate regulatory clearance for its Eclipse Micropen Elite, which it describes as a “dermal...
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Study: High-risk women’s health devices approved on faulty data
Certain high-risk women’s health devices won FDA approval based on flawed data, according to a new study from Northwestern Medicine. Data from the study was published in the journal Obstetrics and...
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Sonova falls short of full-year targets, shares plunge
(Reuters) – Swiss hearing aid maker Sonova missed full-year targets and lowered its sales outlook on Wednesday, suggesting it could take some time to reap benefits from this month’s acquisition of...
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BacTrack wrist-band device for alcohol monitoring wins $200k NIH prize
(Reuters) – A San Francisco-based company has won a U.S. government-sponsored competition with an alcohol monitoring devices that can be worn on the wrist, the latest milestone in the development of...
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Toyota resurrects DEKA’s iBot wheelchair
Toyota Motor North America said last week that it’s planning to resurrect the iBot stair-climbing wheelchair developed by famed investor Dean Kamen’s DEKA Research & Development company. The deal...
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US FDA lays out final guidance on post-market surveillance requirements
By Stewart Eisenhart, Emergo Group Final guidance from the US Food and Drug Administration explains post-market surveillance requirements that pertain to certain types of medium- and high-risk medical...
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