FDA

See the following -

iPad vs. Secondary-class LCD Monitors: It’s a Draw

Evan Godt | CMIO | July 16, 2012

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 »

Liberated Health Data A Catalyst to Innovation

Deanna Glick | AOLGovernment | October 11, 2011

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 »

Medical Device Experts and Their Devices Converse at Boston Conference

Andy Oram | O'Reilly Radar | September 6, 2011

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 »

Regulatory Compliance Officers Need Not Fear Open Source Software in Medical Devices or Mission-Critical Healthcare IT Systems

Shahid N. Shah | HealthcareGuy.com | September 11, 2011

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 »

Regulatory Reporting for Adverse Events

Staff Writer | Business Intelligence Solutions | March 26, 2012

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 »

Tapping Big Data for Early Identification of Preventable Conditions

Roger Foster | Government Health IT | June 4, 2012

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.

Read More »

Using Open Source Software in Safety-Critical Medical Devices

Shahid N. Shah | HealthcareGuy.com | September 4, 2011

...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 »

Verizon Health ID Management Expands to Cover EHRs, HIEs

Ken Terry | Fierce Health IT | September 1, 2011

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 »

When code can kill or cure

Staff | The Economist | June 2, 2012

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 »

FDA Submission: The New Rules

Event Details
Type: 
Open Source Event
Date: 
June 6, 2012 - 6:00pm - 8:00pm
Location: 
4000 Shoreline Court Suite 210
South San Francisco, CA 94080
United States

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:

  • How can clinical trial professionals overcome the increased complexity and cost of clinical trials?...

Read More »