A novel trial design shares patient samples and takes a "universal analysis" approach to accelerate sepsis assays to FDA clearance.

Marie Thibault

Two sepsis assays recently attained FDA clearance in 90 days, a feat made possible by a partnership and innovative trial design.

Earlier this month, Thermo Fisher Scientific, Inc., announced that its 2016 Procalcitonin MOnitoring SEpsis Study (MOSES) trial design allowed license partners Roche Diagnostics USA and bioMérieux to gain quick regulatory clearance. Both the Roche Elecsys BRAHMS PCT assay and the bioMérieux VIDAS BRAHMS PCT assay are now cleared to help assess risk and manage sepsis patients after diagnosis. Roche Diagnostics USA ...

July 20th, 2016
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This amendment clarifies the original intent of the third edition of the electrical safety standard, and some regulatory bodies have already started implementing it.

Marco Fedeli

Compliance with the IEC 60601 series is a requirement for certification of electrical medical products in many countries. While it has evolved over time to include a greater emphasis on risk management and essential performance, the Edition 3.0 contained ambiguities that made execution challenging. Global adoption of the Edition 3.0 has thus been slow, resulting in different transition times by each country’s testing agencies and regulatory bodies.

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July 19th, 2016
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Problems related to production controls account for almost a quarter of medical device recalls, and three failure modes are to blame in more than two-thirds of cases.

Joshua R. Dix, Suraj Ramachandran, and Darin S. Oppenheimer

Editor's Note: This is the third installment in a four-part series on the factors behind medtech's recall epidemic. Read Part 1 and Part 2.

When you take into consideration that elements of the manufacture and servicing of medical devices make up 24% of the controls set in...

July 18th, 2016
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Big data has applications in medtech that extend far beyond electronic health records. An analytics expert explains how data and algorithms have the potential to create a neuroassistive device to help paralyzed patients.

Marie Thibault

Ian Burkhart, who is paralyzed from his shoulders down, swipes a credit card with the help of the NeuroLife technology.

When we think of big data in healthcare, our minds often jump to analysis of patient data in electronic health records or determination of the best therapies for a particular cancer patient. 

But the realm of possibilities is even wider than that. As Stephanie Kute, manager of advanced analytics and health research at Battelle, pointed out in a recent...

July 14th, 2016
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Surgical Training
Developed at the Neurosurgical Simulation Research Centre in Montreal, the NeuroTouch system uses virtual reality combined with haptic feedback tools to enhance surgical simulation.  .

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July 13th, 2016
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Patient Monitoring
At this year's HIMSS conference, Masimo showcased a prototype of a system that paired its Radical 7 noninvasive patient monitoring device with a virtual reality headset from Atheer to give providers a heads-up view of patients' vital signs.
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July 13th, 2016
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PTSD Therapy
Skip Rizzo, a clinical psychologist and associate director for medical virtual reality at the University of Southern California's Institute for Creative Technologies, has researched use of the Oculus Rift virtual reality headset in exposure therapy to help veterans overcome post traumatic stress disorder.
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July 13th, 2016
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Prosthesis Training
Researchers at the Vienna University of Technology have explored using the Oculus Rift virtual reality headset to train amuputees on how to use upper limb prostheses.
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July 13th, 2016
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Easing Patients' Anxiety
Back in 2014, physicians at the Hospital Perpetuo Socorro, working in conjunciton with the University of Las Palmas Gran Canaria and software development company Droiders, used the Oculus Rift virtual reality headset to calm a patient during a medical procedure. The patient, who was undergoing arthroscopy on her knee, opted for local anesthesia augmented by a calming virtual environment enabled by the Oculus Rift, as...
July 13th, 2016
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Concussion Diagnosis
In April, FDA cleared Eye-Sync, a virtual reality device from Boston-based SyncThink that can help diagnose concussions. The headset prompts the user to follow a moving dot with their eyes and measures jitters in their eye...
July 13th, 2016
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