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  • GE, Banyan head to FDA meeting on TBI biomarkers as R&D hits critical mass

    Research is advancing rapidly to validate imaging and blood biomarkers that can easily identify concussions and other traumatic brain injuries on the battlefield, in the sports arena and in emergency care rooms. The FDA demonstrated that the issue is a top priority for it by setting up a public meeting on March 3 to address the scientific developments, regulatory challenges as well as big data standardization, sharing and analysis issues raised by the hunt for TBI biomarkers.

Illumina enlisted for bioinformatics on 100,000 Genomes Project in U.K.

Illumina was right at the core of a plan unveiled in August 2014 by the U.K. government to map 100,000 human genomes by 2017. Its early role focused on whole genome sequencing, but now the genomics giant has also been tapped for bioinformatics as well.

TransEnterix opens $44M equity facility as it awaits FDA go-ahead to launch surgical robot

Robotic surgery aspirant TransEnterix said it has raised $18 million under its equity sales facility since September 2015, as it seeks FDA clearance of its Surgibot System.

Another win for 'gamification': FDA clears Microsoft Kinect-based physical therapy system

"Gamification" is the new buzzword in med tech. After all, playing games can make tasks fun and provide a source of motivation. In the latest example, the FDA cleared the Yugo Microsoft Kinect-based physical therapy system.

23andMe tackles infertility testing with big data player Celmatix

23andMe has concentrated on diversifying its offerings since falling out with the FDA over its genetic testing products a few years ago. Now the company is adding another chapter to its comeback story, striking a deal with big data company Celmatix to work on infertility testing.

Health system UPMC leads $17M financing for mental health wellness services app

Lantern aims to put mental health services and professionals at the patient's fingertips with its online and mobile programs in cognitive behavioral therapy. To help it do so, Pittsburgh-based healthcare provider and payer UPMC is leading a $17 million investment and it also will partner with the San Francisco-based startup to conduct pilot testing of its approach.


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Coming just a few days after the U.S. Pharmaceutical Research and Manufacturers of America (PhRMA) called laws in India governing intellectual property "weak," a report out from the subcontinent says the Indian Pharmaceutical Alliance (IPA) is making moves to assuage concerns from the U.S. Trade Representative over its IP laws.


While much of the news in recent months on warnings issued by the U.S. Food and Drug Administration centered on alerts issued to Indian pharmaceutical manfacturers, active pharmaceutical ingredient and drug manufacturers In China have also received their own set of alerts under the FDA's Form 483 regime, according to a report by the Regulatory Affairs Progessionals Society.