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Nico launches trial for brain surgery shunt
Nico Corp said today it enrolled the 1st patient in the Enrich clinical trial which aims to explore the use of its BrainPath Approach for treating intracerebral hemorrhages. The trial will examine the...
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Transition to the new European Medical Device regulations: Risks for the...
By Stewart Eisenhart, Emergo Group In their effort to safeguard the quality of Notified Bodies (NBs), European authorities are increasing scrutiny. This has resulted in a reduction of the number of NBs...
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Stryker gains on Q4 prelims
Stryker (NYSE:SYK) shares are up after the orthopedics and hospital equipment giant posted preliminary financial results for the 4th quarter that narrowly beat the consensus forecast on Wall Street....
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FDA clears next-gen Sonablate prostate device from SonaCare
SonaCare Medical said today that it won 510(k) approval from the FDA for the latest version of its high intensity focused ultrasound prostate tissue ablation device. The Sonablate device was the 1st of...
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Integra LifeSciences to acquire Derma Sciences for $200m
Integra LifeSciences (NSDQ:IART) said yesterday that it agreed to pay nearly $200 million for Derma Sciences (NSDQ:DSCI) and its line of wound care products. The $7-per-share deal includes a line of...
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Globus Medical posts Street-beating prelims
Globus Medical (NYSE:GMED) saw its shares tick upwards after it beat analysts’ expectations on Wall Street with its preliminary 4th quarter financial results. The Audubon, Pa.-based company said it...
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Layoffs ahead for ReWalk Robotics
ReWalk Robotics (NSDQ:RWLK) is reportedly planning to cut its operating expenses by 30% in 2017, a move that’s slated to include layoffs for an unspecified number of workers. The Marlborough, Mass.-...
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Intuitive Surgical Q4 prelims beat estimates
Intuitive Surgical (NSDQ:ISRG) shares gained after it posted preliminary financial results for the 4th quarter, beating analysts’ expectations on Wall Street. The Sunnyvale, Calif.-based company said...
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The Design Differences of a “Medical-Grade” Foot Control
As medical device OEMs know, a product designed for the medical market is fundamentally different from one intended for industrial use. This is also true for a foot control. From the bottom pads to the...
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POC Medical raises $21m for portable breast cancer screener
POC Medical Systems said today that it raised $21 million in Series A financing to fund clinical testing and commercialization of its portable breast cancer screening test, MammoAlert. The round was...
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Califf on the way out at FDA, Ostroff to take over as interim commish
Dr. Robert Califf’s tenure as commissioner of the FDA, which formally began only last February, will reportedly end less than a year after it began. Califf, like most political appointees in...
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Arterys wins 510(k) clearance for medical imaging analytics software
Arterys said today that it won 510(k) approval from the FDA for its Cardio DL medical imaging analytics software for cardiac MRI images. The San Francisco-based company said its software leverages...
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InVivo beats shareholder suit, adds another clinical site
The 1st U.S. Circuit Court of Appeals upheld the dismissal of a shareholder lawsuit against InVivo Therapeutics, saying that the plaintiff did not do enough to prove that the defendants committed...
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MassDevice.com +5 | The top 5 medtech stories for January 11, 2017
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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Endologix cuts outlook for 2017
Endologix is reportedly lowering its revenue growth outlook to flat- to low-single digits. The company has previously said it expects mid-single digit growth for 2017. The Irvine, Calif.-based...
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Malaysian authorities publish medical device registration transfer policy
By Stewart Eisenhart, Emergo Group EMERGO SUMMARY OF KEY POINTS: The Malaysian MDA has put out new guidance for medicald evice registration transfers. Registration transfers are only available for...
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Clearwater Clinical raises $6m Series A for Shoebox table audiometer
Clearwater Clinical said today that it raised a $6 million Series A round for its Shoebox tablet-based audiometer, taking its total raise to nearly $10 million. The round was led by Toronto’s Whitecap...
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Shire to pay feds $350m to settle DermaGraft kickbacks case
The U.S. Justice Dept. said yesterday that Shire (NSDQ:SHPG) and its subsidiaries will cough up $350 million to settle allegations that Shire and the company it acquired in 2011, Advanced BioHealing,...
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FDA warns on MRI risks with infusion pumps
The FDA issued a warning today that the strong magnetic fields used in an MRI exam can affect implantable infusion pumps. The federal watchdog has received reports of serious adverse events, including...
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Grifols pays $51m for minority stake in Access Biologicals
Grifols (NSDQ:GRFS) said today that it paid $51 million for a 49% stake in Access Biologicals, in a deal that includes an option to acquire the rest of the business. That option, for the remaining 51%...
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