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FDA approves sleep apnea tech from EnsoData, Samsung

Healthcare It News

EnsoData announced Tuesday that it has received FDA 510(k) clearance for an AI algorithm called EnsoSleep to support the diagnosis of sleep disorders using any FDA-cleared pulse oximeter, which measures the saturation of oxygen carried in red blood cells. between 2008 and 2021, CBS News said in a story on how to apply.

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Monthly Round-Up of What to Read on Pharma Law and Policy

Bill of Health

Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016. Characterization and corroboration of safety signals identified from the US Food and Drug Administration Adverse Event Reporting System, 2008-19: cross sectional study. Limitations on the Capability of the FDA to Advise.

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Monthly Round-Up of What to Read on Pharma Law and Policy

Bill of Health

Biomarker qualification at the European Medicines Agency: a review of biomarker qualification procedures from 2008 to 2020. Experts’ Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care. A full posting of abstracts/summaries of these articles may be found on our? 2022 Feb 9.

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HHS Recommends Re-Classification of Marijuana as a Schedule III Controlled Substance – A Bellwether for the Future of Cannabis-ness

Health Law Advisor

The HHS recommendation is predicated, via the FDA, on a scientific and medical evaluation of marijuana, using a statutorily required eight-factor analysis. This effectively allows the DEA to adopt a different outcome than the FDA. The agencies rarely disagree on final scheduling placement. heroin, LSD, and ecstasy).

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Record Numbers of People in the U.S. Putting Off Medical Care Due to Cost – A New “Pink Tax” on Women?

Health Populi

a different fiscal impact than that felt by men in the 2008-9 Great Recession). “Self-care” will take on many meanings and product/service iterations that may be outside of mainstream FDA-regulated and commercially reimbursed care. Is this a new riff on the so-called “Pink Tax?”

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4 Things Healthcare Facilities Should Know About Medical Device Recalls

HIT Consultant

And that’s just what we can see has been “posted” on the FDA site through June 25, 2021. The FDA has noted that recalled medical devices caused almost 100,000 deaths between 2008 and 2021 — but before and after this time period ? Recalls are voluntarily done by a manufacturer.

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Investing in Modern and Advanced Treatment Devices to Help Treatment-Resistant Patient Populations

HIT Consultant

After years of research and clinical studies, TMS was cleared by the FDA for treatment-resistant depression (TRD) in 2008. Ten years later, Mark S. George, M.D. demonstrated the antidepressant effects of repetitive TMS (rTMS). TMS and Deep TMS™ are modern and advanced mental health treatment devices used by clinicians across the globe.

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