September 14, 2020
Fitbit’s new electrocardiogram app has officially received regulatory clearance in the U.S. and European Union for its latest smartwatch, the Fitbit Sense, to monitor heart rhythm and detect atrial fibrillation.
Now that the app has 510(k) clearance from the U.S. Food and Drug Administration and CE marking, Fitbit Sense users can access the ECG app beginning in October.
The company conducted a...
August 29, 2019
Tel Aviv, Israel-based Biobeat has been granted 510(k) clearance for a remote monitoring device capable of measuring the wearer’s blood pressure, oxygenation and heart rate.
Designed for use in the hospital or at home, the device is available as either a wristwatch or adhesive patch. Of particular note, the products differentiate themselves from other remote monitoring devices through a...
May 13, 2019
Kibbutz Shefayim, Israel-based deep learning startup Zebra Medical Vision announced yesterday that it has received an 510(k) clearance for an artificial intelligence tool that can read medical imaging to identify potential cases of pneumothorax — a build-up of gas between a lung and the chest wall.
The HealthPNX product scans a chest X-ray or digital radiography scan for signs of the condition,...
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...
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...
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...
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...
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...
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.
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...