GE HealthCare announced it signed a $44 million contract with the Biomedical Advanced Research and Development Authority (BARDA) to develop AI-enabled point-of-care ultrasound technology to help clinicians diagnose and treat lung pathologies and traumatic injuries to the head, chest and abdomen.
The medtech company will build off its existing ultrasound technology to develop an AI-powered...
In a little over a decade there will be more people age 65 years and older than those under the age of 18 years – an inflection point that highlights healthcare-related paradigm shifts on the horizon. Medical vulnerabilities of diverse older adult communities – as magnified by COVID-19 – have accelerated health inequities impacting the quality of life of millions of families and family caregivers...
The Biden administration is rolling out a new set of digital services to help Americans find COVID-19 vaccines. The new tools are multimodal, as well as multilingual, and include text-based services, a website and a call number, which will all be available in English and Spanish.
“We want to make it as easy as possible for people to get vaccinated, once they make the decision to do so," Surgeon...
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 Stephen Hahn has stepped down and has been replaced by acting Commissioner Dr.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...
Cue Health, a rapid diagnostics startup with a connected testing device platform, has been awarded $481 million from HHS and the Department of Defense (DoD) to expand production of a COVID-19 molecular test that received an Emergency Use Authorization back in June.
According to announcements from the government and the startup, the money will be used to deliver six million COVID-19 molecular...
Following numerous reports of underperforming COVID-19 antibody tests, the FDA has raised the bar for these products in a revision to its emergency testing policy.
As of today, commercial manufacturers that notify the agency of their intent to submit a test for Emergency Use Authorization are required to do so within 10 business days from the date of notification. Further, the FDA has recommended...
This morning the US Department of Health and Human Services dropped its long-awaited final rules on interoperability, information blocking and patient access.
While the two final documents from the HHS Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) specify a number of new requirements laid out in the 21st...
As 2020 gets underway, the federal government has set its sights on bringing innovation to an area of health that affects one in seven Americans and costs the government more than NASA and the Department of Commerce combined, yet hasn’t seen major innovation since the 1970s.
That area is kidney disease. Both HHS Chief Technology Officer Ed Simcox and HHS Deputy Secretary Eric Hargan addressed the...
The FDA and National Institutes of Health are tapping the clinical community and a newly launched mobile platform in its search for novel infectious disease interventions.
Called CURE ID, the online data repository will allow clinicians to report instances in which existing FDA-approved drugs are used to successfully treat infections.
In particular, the tool captures clinical outcomes in cases...
Friday marked the end of Dr. Ned Sharpless’ time as acting commissioner of the FDA, with President Donald Trump pointing to Dr. Stephen Hahn, currently the chief medical officer of MD Anderson Cancer Center, as his official appointment for the role on Friday. Assistant Secretary for health at HHS Dr. Brett Giroir will act as the agency’s new acting head.
“With Dr. Sharpless at the helm, the FDA...
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