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.
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.
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.
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, 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.
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but may not have much practical effect since the agency limited its role in the regulation of software in a June draft guidance.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.