Latest Headlines

Latest Headlines

Congress considering bill to limit FDA regulation of EHRs, clinical decision support software

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but may not have much practical effect since the agency limited its role in the regulation of software in a June draft guidance.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 to stop regulating some medical device software

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registration and Quality System Regulation, that normally apply to Class I devices, the agency said in a June 20 draft guidance.

Statisticians fret over misuse of data-crunching software

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.   

Fierce's Top 10 Biotech Techies

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...

Google Ventures, VCs backing tech focused on genomics

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's big IT budget gets thumbs down from analysts

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...

Entelos stages comeback bid with funding

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,

AstraZeneca taps IMS Health for mining 'real-world' data sources

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

Brain Resource scores $10M, opens SF office

Brain Resource ($BRRZY), an Australian provider of web-based products for brain research, has landed in San Francisco with $10 million to ramp up its presence in the research, patient care and...

Case Western spinoff wins NIH grant for software

Biomarker upstart NeoProteomics has grabbed a $300,000 grant from the NIH to fund development of its bioinformatics software. The software, licensed from Case Western Reserve University, is designed