FDA's Bakul Patel
Last June in a draft guidance document, the FDA proposed to further de-regulate a specific type of health software, which included a number of mobile medical apps and telehealth platforms, from FDA-registered Class 1 devices to an unregulated status. Last week the FDA moved to finalize that guidance, building on a spate of recent guidances that both make clear where...
Durham, North Carolina-based Validic recently announced a $1.25 million convertible note from SJF Ventures and undisclosed angel investors. Validic CEO Ryan Beckland told MobiHealthNews that the new investment brings the company's total up to $2.1 million to date, but really serves as a bridge to get it to its series A round, which it is in the process of raising now.
Validic describes itself as...
Amcom Software announced this week FDA 510(k) clearance for its Amcom (Commtech) Messenger middleware as a class II medical device intended for hospital use.
The Amcom Messenger middleware sends critical secondary notifications from patient monitoring and other alert systems to staff carrying wireless communication devices, including smartphones, pagers, and Wi-Fi phones.
"Systems like this --...
"Soap it off or eat it later," read one rather to-the-point reminder for men to wash their hands in the bathroom. Researchers from the London School of Hygiene and Tropical Medicine set-up wireless sensors in highway service station restroom to determine how best to encourage patrons to wash their hands after using the facilities: "Absent such reminders, the study found, only 65 percent of women...
