Regulation

The Analytic for Hemodynamic Instability tool can identify hemodynamic instability with 96% sensitivity and detects stable patients with 85% specificity.
By  Mallory Hackett 12:26 pm March 2, 2021
Fifth Eye, a Michigan-based real-time clinical analytics company, announced today that the Food and Drug Administration has granted De Novo classification for its Analytic for Hemodynamic Instability (AHI) tool. The technology links with hospitals' existing electrocardiograms to create a reading of patients' hemodynamic status every two minutes. Once AHI completes a reading, it uses machine...
By  Dave Muoio 02:06 pm 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...
NHSX, NHS
By  Tammy Lovell 11:03 am February 24, 2021
NHSX has launched a new process to help give staff, patients and the public confidence that the digital health tools they use meet NHS standards. The digital technology assessment criteria (DTAC) is a rapid process that can be completed in days.  It will apply to all digital health technologies, from public facing health apps to systems used within hospitals such as electronic patient records....
Pulse oximeter
By  Laura Lovett 01:47 pm 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...
By  Dave Muoio 12:09 pm 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...
Brexit, MHRA
By  Sophie Porter 02:09 am January 6, 2021
Following its recent departure from the EU, the UK has introduced a new medical device information system (MDIS) that requires all medical devices available on the UK market to be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) using official global medical device nomenclature (GMDN). The new system came into effect on 1 January 2021, with certain devices allowed a...
Australian regulator rejects Google’s Fitbit undertaking, delays acquisition decision.

Carsten Koall/Getty Images

By  Mallory Hackett 02:35 pm December 23, 2020
The Australian Competition and Consumer Commission on Tuesday rejected an undertaking proposed by Google to address competition concerns over its planned acquisition of Fitbit. The ACCC in June released a list of issues it had with the merger that included concerns that Google would be given too much access to people’s data, as well as decreasing competition in the wearables market. Google...
Motor vehicles stalled in a traffic jam
By  Bradley Merrill Thompson 09:35 am 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...
By  Dave Muoio 12:29 pm December 17, 2020
Following months of regulatory investigation, the European Commission has officially signed off on Google's $2.1 billion purchase of health-wearable-maker Fitbit. Still, the go-ahead is contingent on a handful of commitments from the tech company that focus on its competitive practices across advertising, digital health APIs and smart device interoperability. "We can approve the proposed...
Three screens of the Ellume COVID-19 Home Test App
By  Dave Muoio 03:13 pm 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...