March 29, 2021
On Thursday, Amazon landed an FDA Emergency Use Authorization for its COVID-19 test kit with at-home sample collection.
According to FDA documents, the product is cleared for self-sample collection by nasal swab for individuals aged 18 years and over. The kit can be used either under the supervision of a healthcare provider or unsupervised at home. The kit includes a nasal swab, a collection tube...
March 26, 2021
In Germany, the public health insurers are in charge of the ePatient record (ePA) app delivery. MobiHealthNews asked Sandra Hoyer, ePA project manager at one of Germany’s main insurers, Techniker Krankenkasse (TK), how the implementation works - and how it has been used so far.
Q. The payers are responsible for providing the national ePA in Germany. How does that work?
At the moment we provide...
March 24, 2021
Everlywell, a leader in the at-home diagnostic testing space, has acquired PWNHealth and its subsidiary Home Access Health to form a new parent company called Everly Health.
PWNHealth and Home Access Health both have self-collected lab test services, and by combining the companies, Everly Health will support more than 20 million people annually in all 50 U.S. states, Canada and Puerto Rico,...
March 23, 2021
UK biotech firm Genomics plc is working with the NHS on a pilot study using genetic information to predict patients’ risk of heart disease.
Around 1,000 people in north-east England who attend routine GP health checks, will take part in the trial.
An integrated risk tool (IRT), created by Oxford University spin-off Genomics plc, will be used to estimate each patient's risk of developing...
March 19, 2021
Over the past few years, we’ve seen an acceleration of efforts and much needed innovations in the healthcare system, including the recognition of the importance of the social determinants of health (SDOH) on patient outcomes and care.
However, creating a truly connected ecosystem that addresses all aspects of a patient’s care (clinical and social) is only possible with the right supporting...
March 18, 2021
This week, the Food and Drug Administration shared that it will allow marketing for some COVID-19 screening tests before their effectiveness is studied in asymptomatic individuals.
Test developers seeking this over-the-counter authorization can apply using a template provided by the FDA to share data on who the test is intended for and how well the test works, and provide instructions for its use...
March 17, 2021
AI isn't ready for COVID-19 prime time. A systematic review of published this week in nature machine intelligence warns that new models using machine learning to review chest radiographs and chest computed tomographies for COVID-19 have major methodical deficiencies or underlying biases.
Among the 62 published or pre-print papers outlining these approaches, the authors wrote that not a single one...
March 11, 2021
Today the employer-based family-benefits platform Cleo announced a slew of new product features aimed at helping working Black and BIPOC-identifying families navigate today’s healthcare system.
Discrimination based on race is nothing new in healthcare, but the pandemic laid bare just how much race impacts a person’s health outcomes. In fact, Black and African American individuals are 1.1 times...
March 11, 2021
Today there are still a lot of questions around getting the workforce back into the office, clinic or manufacturing site. Digital health company Truepill is looking to address this issue by teaming up with the Health Transformation Alliance to offer Truepill's new employer-focused suite of COVID-19-focused diagnostics and digital tools to the former's members.
Truepill's new program will...
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...