The FDA's device arm continued its light-touch approach to regulating medical software and other newfangled health information technologies that are either relatively simple or don't pose a clinical risk to patients. In technical terms, FDA utilized its "enforcement discretion," meaning the agency believes it has the authority to regulate the devices but opts not to.
IBM's artificial intelligence tool Watson is an expert at Jeopardy, but it can't answer the question as to whether the technology should be regulated as a medical device. That decision rests with Congress and the FDA, or perhaps lobbyists.
A bill circulating the halls of Congress would limit the FDA's oversight of electronic health records and clinical decision support software, but may not have much practical effect since the agency limited its role in the regulation of software in a June draft guidance.
FDA will exercise "enforcement discretion" in its regulation (or lack thereof) of medical device data systems by opting not to enforce the general controls, such as product registration and Quality System Regulation, that normally apply to Class I devices, the agency said in a June 20 draft guidance.
The rise of complex data-crunching techniques and software has put powerful statistical approaches into the hands of more scientists. While this has democratized the ability to probe information for insights, it has also increased the risk scientists will misuse statistics and find false positives. Statisticians are worried.
Tech-savvy scientists can help pull the biopharma industry out of the proverbial muck. Drugmakers have fallen short of expectations in translating research breakthroughs into medicines. There are no...
In its examination of the many potential challenges in genomics, Bloomberg made note of how venture capital is playing a role in advancing technologies that aim to tap the full potential of genomic...
Covance ($CVD) wants to reduce annual increases in its information technology budget, but the big CRO told investors Wednesday that it was going to have to make some major investments in the short...
Back out of bankruptcy, modeling and simulation software company Entelos has recapitalized its business and brought on a new investor, the San Mateo, CA-based company said last week. The company,
With a greater burden of proof on drugmakers to get payment for new medicines, London-based pharma AstraZeneca ($AZN) has partnered with IMS Health to scour multiple sources of data for real-world