FDA
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iPad vs. Secondary-class LCD Monitors: It’s a Draw
When reviewing spinal emergency cases on MRI, increased mobility doesn’t have to come at the cost of reduced reader accuracy as no statistical difference was seen in a multi-reader comparison of diagnostic accuracy between the iPad and a DICOM calibrated secondary-class LCD monitor, according to a study published in the August issue of Academic Radiology. Read More »
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Liberated Health Data A Catalyst to Innovation
The chief technology officer for HHS said efforts to liberate health records and data within the federal space will spur innovation in the public and private sectors that improves Americans' health and health care. Read More »
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Medical Device Experts and Their Devices Converse at Boston Conference
I'm looking forward to Medical Device Connectivity conference this week at Harvard Medical School. It's described by one of the organizers, Shahid N. Shah, as an "operational" conference, focused not on standards or the potential of the field but on how to really make these things work. Read More »
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Regulatory Compliance Officers Need Not Fear Open Source Software in Medical Devices or Mission-Critical Healthcare IT Systems
I spent the past few days in Boston at the Harvard Medical School Conference Center speaking audiences at the Medical Device Connectivity Conference (I presented lectures on how to design next-generation medical devices and gateways). Read More »
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Regulatory Reporting for Adverse Events
Regulatory reporting allows life science manufacturers to identify adverse events before they become critical issues, facilitating proactive risk avoidance and product regulatory and safety adherence, both now and as regulations continue to evolve. Read More »
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Tapping Big Data for Early Identification of Preventable Conditions
The cost to the U.S. healthcare system from preventable conditions and avoidable care has been estimated in the range of $25-50 billion annually. Preventable conditions are a significant component of the $600-850 billion surplus in healthcare spending ultimately increasing cost and decreasing the overall quality of public health.
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Using Open Source Software in Safety-Critical Medical Devices
...As we know, FDA regulated medical devices are considered safety-critical systems due to their ability to affect patient lives. Given the nature of scrutiny and the requirement to play it safe, most medical device vendors end up choosing proprietary or custom solutions for operating systems, databases, messaging platforms, alarm notification systems, and event logging. Read More »
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Verizon Health ID Management Expands to Cover EHRs, HIEs
Verizon is expanding its cloud-based identity-management services for healthcare providers. Verizon Universal Identify Services-Healthcare, founded in November 2010, now supports new identity standards for accessing electronic health records and health information exchanges. In addition, it offers new features for electronic prescribing, including the prescribing of controlled substances... Read More »
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When code can kill or cure
Applying the “open source” model to the design of medical devices promises to increase safety and spur innovation. However, when software in a medical device malfunctions, the consequences can be far more serious than just having to reboot your PC. Read More »
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FDA Submission: The New Rules
Save the date and register now for our next session of the Silicon Valley BioTalks. Clinical and regulatory experts will share their experience on June 6th to help you understand the evolving regulatory requirements and to better prepare for a successful FDA submission.
Discussion topics include:
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How can clinical trial professionals overcome the increased complexity and cost of clinical trials?...
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