Latest Headlines

Latest Headlines

J&J working with nonprofit to enable open-source software to combine diabetes device data

Johnson & Johnson's Animas is working with Type 1 diabetes technology nonprofit Tidepool to use its open-source software platform to assemble and analyze data for diabetes device, fitness and food tracking. The news comes in the wake of announcements in recent months from major diabetes device makers, including Medtronic, DexCom and Insulet, that they are partnering with startup Glooko to similarly enable connectivity as well as data transmission and analysis.

Harvard Wyss Institute spins out apnea prevention startup MediCollector

Researchers at the Wyss Institute for Biologically Inspired Engineering at Harvard University developed bedside data-acquisition software as part of its infant apnea prevention program. Now, it's spun off the technology into a new startup known as MediCollector.

FDA classifies ventilator recall as Class I after software causes freeze

Hamilton Medical is facing another software-based recall of its ventilators, after having a similar issue in 2013. This time around, the private ventilator care company recalled almost 250 of its most advanced ventilators from U.S. healthcare providers.

U.K. to fund camera-based patient monitoring prototype development after initial study

Innovate U.K., the country's agency designed to foster technology advances, will fund the development of a prototype for a camera-based, remote patient monitoring system from Oxehealth that's ready to be deployed in real-life settings. This comes just as the startup reports positive results from a proof-of-concept study that was also funded in part by the same agency.

Philips collaborates with Dutch hospital to develop diabetic foot disease Dx

Royal Philips and the Academic Medical Center in Amsterdam, the Netherlands, will collaborate in a European multicenter trial of a new diagnostic technique to assess the results of minimally invasive treatment for diabetic foot and critical limb ischemia. The trial is slated to start this summer with final results expected in 2017.

Samsung partners to develop next-gen health and wellness software, mobile apps

Samsung, along with several other electronics conglomerates, is working to puzzle out what's next in mobile healthcare. A growing foothold in healthcare could aid these companies, which are vulnerable to the vagaries of eroding profit margins and rapidly evolving technology.

FDA once again steers clear of health IT, finalizes plans to stop regulating some medical software

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.

How should IBM's Jeopardy-winning Watson be regulated?

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.

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.