FDA 510(k) clearance

By  Jonah Comstock 08:58 am July 8, 2013
EPI Mobile Health Solutions, a Singapore-based company, has received FDA clearance for a smartphone-enabled ECG device -- one which the regulatory agency refused to import last fall. The company claims on its website to be "the world’s first, patented Electrocardiogram ('ECG') function integrated onto a mobile phone," likely referring to its EPI Life mobile phone offering. EPI Mobile Health has...
By  Neil Versel 02:06 pm May 22, 2013
The pre-FDA clearance version of MobileCT Nephosity, a San Francisco-based startup, has joined the swelling ranks of companies to receive Food and Drug Administration (FDA) 510(k) clearance for a mobile medical imaging app. The FDA has approved Nephosity's MobileCT Viewer iPad app for remote diagnostic viewing of CT, MRI and X-ray images when a fixed workstation is not readily available,...
By  MHN Staff 07:37 am April 15, 2013
By Bradley Merrill Thompson, EpsteinBeckerGreen I’ve always found the saying, “Be careful what you wish for; you might just get it” to be rather condescending. In a way it suggests that we are too stupid to manage our own affairs. But like any popular saying, it probably has a kernel of truth. Frankly, I’m a little nervous about a request made by industry for international medical device...
By  Neil Versel 03:00 am January 8, 2013
The Beam Brush, touted as the first toothbrush connected to a mobile app, officially hit the market on Monday, with consumer and professional offerings as well as a gamification aspect. Beam Technologies, of Louisville, Ky., is selling the manual brush with embedded brushing sensor and Bluetooth radio, for $49.99. A free companion app for Android or Apple iOS tracks brushing habits, including...
By  Jonah Comstock 10:39 am November 16, 2012
A Beijing-based medical device company called Raiing has been granted 510(k) FDA clearance for the Raiing Wireless Thermometer, a peel-and-stick contact thermometer sensor that continuously transmits body temperature readings to a companion iPhone app, which is already available in the iOS AppStore. The app is called Vitals Monitor and is currently available for a free download, but the device...
By  Brian Dolan 05:00 am July 19, 2012
In recent weeks LUMOback, the startup developing a wearable sensor and companion app that help users become more aware of their posture, raised more than $100,000 on crowdfunding site, Kickstarter. As we noted in a previous post, LUMOback managed to raise funds on the site even though it has rejected many other health and wellness-related projects in recent months. More recently Shiv Gaglani at...
By  Brian Dolan 05:24 am July 11, 2012
Asthmapolis announced today that the US Food and Drug Administration (FDA) has granted its asthma sensor and companion software 510(k) clearance. The company's device is a sensor that sits atop (most) inhalers used by patients who have asthma or COPD. The sensor transmits data to a companion app on the user's mobile phone every time the inhaler is used. The app can then track the time and...
By  Brian Dolan 07:18 am June 11, 2012
San Francisco-based AliveCor, which has developed the iPhoneECG and iCard ECG, electrocardiogram peripheral devices for smartphones, has raised $10.5 million in its second round of funding. New investor Khosla Ventures led the latest round of funding along with return backer Burrill & Company. Existing investors Qualcomm Life Fund and Oklahoma Life Sciences Fund also contributed. AliveCor,...
By  Brian Dolan 10:10 am December 14, 2011
Sotera CEO Tom Watlington Sotera Wireless announced that it had raised $12.2 million in its fourth round of funding. Singapore-based global fund EDBI led the round, which included participation from new investor Cerner Capital and existing investors Sanderling Ventures, Qualcomm Ventures, Intel Capital and the West Health Investment Fund. The latest round of funding brings total investment in...