FDA

By Jonah Comstock October 18, 2017
Pear Therapeutics announced today that reSET-O, a digital therapeutic for opioid use disorder, has received an Expedited Access Pathway (EAP) designation from the FDA. The EAP designation doesn't mean that the FDA has cleared the product, only that it has committed to fast-tracking it through the clearance process because of its timely public health value.  “The opioid epidemic continues to...
By Jonah Comstock October 5, 2017
Paris-based Cardiologs has raised $6.5 million to support its AI-powered algorithm for ECG analysis. The round was led by a syndicate of investors including Idinvest, ISAI, Kurma Partners, and Partech Ventures, with additional participation from Bpifrance seed fund, an existing investor. This brings the company's total funding to $10 million. “Ambulatory ECG analysis and reporting is a labor-...
By Dave Muoio October 4, 2017
Redwood City, California-based Carrot has received FDA 510(k) clearance for its Carbon Monoxide Breath Sensor System, an over-the-counter, Bluetooth-enabled device that pairs with a smartphone app and is intended for commercial use in smoking cessation programs. “Smoking is the number one cause of preventable illness and death worldwide,” Dr. David S. Utley, founder and CEO of Carrot, said in a...
By Jonah Comstock September 27, 2017
Abbott Diabetes Care's Freestyle Libre Flash Glucose Monitoring System has been approved by the FDA. As well as finally bringing the system, which is already available in 39 other countries, home to the US where Abbott is based, the approval also represents a first for continuous glucose monitoring, as it doesn't require the user to use a fingerstick, even for calibration. "From an emotional...
By Jonah Comstock September 26, 2017
Just two months after announcing the applications for its pre-certification program pilot, the FDA has announced the nine companies that will be participating. The list includes major tech companies Apple and Samsung; health tech companies Verily, Pear Therapeutics, Tidepool, and Phosphorus; pharmaceutical companies Roche and Johnson & Johnson; and Fitbit — an interesting inclusion insofaras...
By Jonah Comstock September 15, 2017
One of the biggest promises of mobile health apps and wearables is the sheer amount of data they collect. As that dataset grows, a number of different stakeholders are taking an interest in it, among them patients themselves, doctors, and clinical researchers. The latter is the focus of a new report out today from the Duke-Margolis Center for Health Policy. “Under a collaborative agreement with...
By Jonah Comstock September 14, 2017
In an FDA first, Boston- and San Francisco-based Pear Therapeutics' reSET system for the treatment of substance abuse has been granted a de novo clearance by the agency. It's the first software-only digital therapeutic the FDA has cleared with claims to improve clinical outcomes in a disease. “This is a defining moment for digital therapeutics and for patients with substance use disorder,” Corey...
By Jonah Comstock September 11, 2017
Boston-based eye tracking company SyncThink has made major changes to its marketing materials since the FDA objected to its labeling in a warning letter. The letter is dated July 31st; MedCityNews first spotted the missive. "Specifically, the EYE-SYNC device was cleared as a prescription device under K152915 with the following indications for use: recording, viewing, and analyzing eye movements...
By Jonah Comstock September 7, 2017
Proteus Digital Health has made a high-profile addition to its board of directors: Dr. Regina Benjamin, who served as US Surgeon General from 2009 to 2013. "I am honored and excited to join the board of Proteus Digital Health,” Benjamin said in a statement. “As a nation, we are facing increasing challenges with chronic illnesses such as hypertension, diabetes, heart disease, hepatitis, behavioral...
By Jonah Comstock September 1, 2017
Computers, whether through simple decision trees or complex neural networks, are increasingly playing a larger and larger role in helping healthcare providers make treatment decisions. As the role of clinical decision software in healthcare grows, so too does the need for guidelines that allow clinicians and patients to trust and understand that software. This week, the CDS Coalition, an industry...