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FDA clears Mauna Kea’s Cellvizio Confocal miniprobes
Mauna Kea (ENT:MKEA) said today it won 510(k) clearance from the FDA for its Confocal miniprobes designed for use with the company’s Cellvizio platform. The newly-cleared Confocal miniprobes are...
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Elekta wins Swedish hospital supply deal
Elekta (STO:EKTA B) said today it won a supply agreement with the Stockholm County Council to supply equipment to its flagship New Karolinska Solna hospital. The company said it expects the deal to be...
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MassDevice.com +5 | The top 5 medtech stories for May 25, 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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Chinese regulators expand list of medical devices exempt from clinical trial...
By Stewart Eisenhart, Emergo Group The China Food and Drug Administration (CFDA) has issued two new draft lists of medical devices to exempt from clinical trial requirements. The regulator is seeking...
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Israeli machine-learning radiology firm Zebra Medical Vision raises $12m
Israeli machine-learning radiology firm Zebra Medical Vision said today it raised $12 million to support the development of imaging algorithms being designed for automatic reading and diagnosis of...
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OvaScience preps offering to support Augment expansion
OvaScience (NSDQ:OVAS) said today it is opened a new offering of stock as it looks to expand its Augment treatment in Japan and Canada and support pre-commercial activities for its OvaPrime and OvaTure...
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Ortho Kinematics wins Health Canada nod for VMA system
Ortho Kinematics said today it won Health Canada authorization for its Vertebral Motion Analysis spinal imaging system. The VMA system from Austin, Texas-based Ortho Kinematics uses fluoroscopy to...
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FDA panel backs St. Jude’s Amplatzer stroke device in 15-1 vote
An FDA panel Tuesday voted 15-1 in support of St. Jude Medical‘s (NYSE:STJ) Amplatzer cardiac implant for treating patent foramen ovale, according to the Minneapolis Star Tribune. The Amplatzer PFO...
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Respiratory Motion wins CE Mark for ExSpiron minute ventilation monitor
Respiratory Motion said today it won CE Mark approval in the European Union for its ExSpiron non-invasive patient minute ventilation monitor. The ExSpiron patient monitor is designed to improve...
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The world of digital health
We are in an era where mobile platforms, such as smartphones, tablets and wearable devices have become a necessity. Mobile applications that run on these platforms provide a variety of entertainment...
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NeuroMetrix launches Quell Health Cloud on Android
NeuroMetrix (NSDQ:NURO) said today it launched its Quell Health Cloud for Google‘s (NSDQ:GOOG) Android device platform. The newly launched Health Cloud app allows users of Quell devices to set up...
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Diabetes Tech Society releases cybersecurity standards for connected devices
The Diabetes Technology Society this week released its cybersecurity standards for network-connected smart medical device as cyberattacks and data breaches become more commonplace. The group released a...
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TransMedics closes $51.2m round to support its Organ Care System
TransMedics said today it closed a $51.2 million round of equity financing to support its Organ Care System organ preservation device. The company’s flagship Organ Care System is designed to perfuse...
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Centerline Biomedical wraps up pre-clinical study, looks to Series A
Interventional vascular device-focused Centerline Biomedical said today it completed its 1st pre-clinical study evaluating its IOPS endovascular navigation technology and is looking towards a Series-A...
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SuperSonic Imagine wins Japanese clearance for Aixplorer
SuperSonic Imagine said today said it won regulatory approval in Japan for its most recent Aixplorer ultrasound system, which includes new features that allow for the evaluation of liver disease,...
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MassDevice.com +5 | The top 5 medtech stories for May 26, 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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Agreement reached on Europe’s medical device and IVD regulations
By Ronald Boumans, Emergo Group European regulators and lawmakers have agreed on long-awaited new regulations covering medical an in vitro diagnostic devices in one of the world’s largest markets. On...
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Novartis pharma head Epstein steps away, most recent in string of top-level...
Novartis pharma head Epstein steps away, most recent loss in string of top-level turnovers Novartis (NYSE:NVS) is facing an upheaval in its top management, seeing 7 departures over the last 5 months as...
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Theranos sued over blood tests, in proposed class action
(Reuters) – Blood-testing company Theranos Inc was sued on Thursday, accused of endangering customer health through “massive failures” that misrepresented the accuracy and quality of its blood tests,...
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FDA slaps Class 1 label on Medtronic Capnostream battery pack recall
The FDA today labeled Medtronic‘s (NYSE:MDT) voluntary recall of battery packs used with its Covidien Oridion labeled Capnostream 20 and 20p patient monitors as Class I. The devices are being recalled...
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