510(k) clearance

By Laura Lovett January 23, 2019
Looking to modernize the 510(k) process, yesterday the FDA announced its final guidance establishing the framework for the new Safety and Performance Based Pathway.  The biggest change to the 510(k) program is that instead of testing a new device in comparison to what is already on the market, new technology seeking clearance can be measured against a set of “objective, transparent and well...
By Dave Muoio January 10, 2019
The FDA has granted 510(k) clearance to an over-the-counter handheld electronic device for treating hay fever sinus pains, according to an announcement from its manufacturer. Tivic Health Systems’ ClearUP Sinus Pain Relief device is non-invasive and does not rely on a pharmacological component. Instead, the single-button device is run along the skin of the user's cheek, nose and brow, where it...
By Dave Muoio November 28, 2018
Basking Ridge, New Jersey-based medical device maker Electrocore has received a 510(k) clearance expanding the label of its non-invasive vagus nerve stimulator (VNS) therapy device to include cluster headache prevention. According to a release from the company announcing the news, no other devices or pharmacologic treatments have received this indication from the agency. Therapy using the...
By Brian Dolan February 13, 2014
While the most recent meeting made headlines, the first time Apple executives actually met with the FDA wasn't at the end of 2013, but rather three-and-a-half years ago. The Financial Times pointed this out earlier this month. On June 11, 2010 Apple's Vice President of Software Technology Bud Tribble and the company's VP of Worldwide Government Affairs Cathy Novelli met with the FDA's Director of...
By Brian Dolan January 13, 2014
This month the FDA cleared the second generation of Waltham, Massachusetts-based EarlySense's passive and contactless bedside monitor, which continuous measures respiration rate, heart rate and motion. Among the changes to the system are more sophisticated management tools to help administrators better measure and track quality goals. "One of the very strong attributes of our technology and...
By Brian Dolan January 7, 2014
iHealth's not yet FDA-cleared wearable ECG device Mountain View, California-based iHealth Lab, a subsidiary of Chinese medical device company Andon Health, showed off three new smartphone-enabled, wearable health devices at CES in Las Vegas this week: a blood pressure monitoring vest, an ambulatory ECG device that sticks to the wearer's bare chest, and a wristworn pulse oximeter device. None...
By MHN Staff September 4, 2013
By Dan Haley, VP of Government Affairs, athenahealth In 2011 the Food and Drug Administration (FDA) released draft guidance seeking to clarify its intentions with regard to regulation of mobile health information technology (“mhealth IT”). The Agency solicited and received public comment. Thereafter began a nearly two-year waiting game that continues to this day and has more than a few mobile...
By MHN Staff May 1, 2013
By Bradley Merrill Thompson As I said in the prior post, this series is for two types of companies: (1) those that are merely dipping their toes into mHealth because they’re afraid of the water, and (2) those that are diving right in head first with no idea how deep the water is. Both types of companies might be making mistakes, either by letting good opportunities go by or by incurring undue...
By Brian Dolan May 29, 2012
Telcare's mobile diabetes management offerings By Padma Naggapan Three diabetes device companies, Glooko, AgaMatrix, and Telcare discussed their wares and approaches to the wireless-enabled diabetes management market during at panel at last week's WLSA Convergence event in San Diego. Glooko is a Silicon Valley startup that enables diabetes patients to collect and view their glucose meter...