March 5, 2021
The FDA has issued its first emergency use authorization for a COVID-19 molecular diagnostic test that does not require a prescription and can be used at home.
Developed by Cue Health, the Cue COVID-19 Test for Home and Over the Counter Use was first authorized for point-of-care use last June.
It uses a nasal swab sample collected from the lower nose to detect the presence of SARS-CoV-2 RNA, and...
February 25, 2021
The digital health ecosystem has swelled to encompass a broad range of products over the years.
On one end of the spectrum is software-as-medical-devices (SaMD) and prescription digital therapeutics, product categories for which a comprehensive regulatory strategy and engagement with the FDA are mandatory. On the other are wellness apps and other low-risk digital tools that likely spend more time...
February 22, 2021
Pulse oximeters, devices used for estimating blood oxygen levels, may be less accurate in people with darker skin pigmentation, the FDA warns. The tools are often used by patients at-home to monitor conditions, however the FDA cautioned that the technology have limitations and a risk of inaccuracy under certain conditions.
Today many pulse oximeters are digitally connected, which has made the...
February 15, 2021
SPAC rumors pan out. Just a few weeks after rumors spread of Sharecare's upcoming merger with a special purpose acquisition company (SPAC), the patient-engagement and benefits-navigation platform made it official with an announcement on Friday.
Sharecare will be merging with Falcon Capital Acquisition and listing on NASDAQ. The deal is set to be funded through $345 million in cash in trust from...
February 8, 2021
The FDA has granted De Novo authorization to what will be the first device treatment for obstructive sleep apnea (OSA) that is used while the patient is awake.
Called eXciteOSA, the prescription tongue muscle stimulation device is intended for those aged 18 years or older to reduce mild sleep apnea and snoring. Patients use the device for 20 minutes once per day over a six-week period, and...
February 4, 2021
Short seller calls out Clover Health. Hindenburg Research, a short seller that describes itself as a specialist in forensic financial research, published a report criticizing Clover Health's business and alleging that the Medicare Advantage insurtech company has not disclosed active investigations by the Department of Justice.
Hindenburg – which said that it does not have positions for or against...
January 21, 2021
The start of the Biden administration has signaled a changing of the guard throughout the U.S. Department of Health and Human Services.
For the FDA, Commissioner Dr. Stephen Hahn has stepped down and has been replaced by acting Commissioner Dr. Janet Woodcock. She joined the agency's Center for Biologics Evaluation and Research in 1984 and held the position of Center for Drug Evaluation and...
December 23, 2020
It’s been quite a year: COVID-19, a change in administration and a year of transition for FDA digital health policy. In light of all the change and uncertainty, many digital health companies are struggling to decide upon a regulatory strategy for 2021.
My advice? If at all possible, stay away from FDA. They have enough to do right now. The people I know at FDA have been working 12- and 15-hour...
December 15, 2020
The U.S. FDA announced today an Emergency Use Authorization for the first over-the-counter COVID-19 diagnostic test for home use.
Developed by Australian digital diagnostics company Ellume Health, the single-use kit is accompanied by a Bluetooth-connected app that guides users through the testing process and automatically reports its results for disease monitoring.
The test returns its results in...
December 8, 2020
Apple has landed a new FDA clearance for an updated version of its ECG feature, allowing the tool to add a category called A-Fib with high heart rate.
This comes a little over two years after Apple first landed a De Novo clearance for its first version of the ECG reading.
The latest version of the ECG feature will be available when the new software update rolls out. This second generation will...