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Pig Hearts for Humans and the FDA

Bill of Health

Food and Drug Administration (FDA) has not approved any genetically modified or pure animal organs for xenotransplantation in humans. For the surgery to go forward in Bennett’s case, the team had to submit a request to the FDA seeking to use the pig heart in the emergency procedure (so-called “compassionate use” ). Categorization.

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Lunit gets Canadian licenses for AI radiology solutions

Mobi Health News

This follows last year's FDA approvals in the US.

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Ketamine is the New Viagra

Bill of Health

By Vincent Joralemon Spravato, the first FDA-approved psychedelic therapy, just outsold Viagra. Pfizer’s successful clinical trials for ED followed, leading to FDA approval of sildenafil citrate, marketed as “Viagra,” in 1998. This became Spravato, the first FDA-approved psychedelic therapy. Initially, the public is hesitant.

FDA 263
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Vendor notebook: New AI tools to cut billing burdens, improve testing and more

Healthcare It News

" Since launching its claims platform, a series of new capabilities, including prior authorizations and denials management, has been added. miRNA-based cancer diagnostics Ovarian cancer is highly lethal in part because of how difficult it has historically been to diagnose.

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EU and US Regulatory Challenges Facing AI Health Care Innovator Firms

Bill of Health

In a similar vein, FDA only considers medical AI that falls in one of its existing regulatory categories (most often medical device), and even then by way of Congressional action and FDA’s own interpretation of its authority, and its discretion only regulates a subset of medical AI. A different example has to do with how the U.S.

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How Will New FDA Hearing Aid Regulations Impact Health Plans?

HIT Consultant

First, let’s examine the new regulatory framework the FDA established. – Prescription hearing aids will require a consumer to have a prescription for a hearing aid from a physician, audiologist or a licensed hearing instrument specialist. These OTC hearing aids do not require a prescription. . yet is largely untreated.

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Accessing COVID-19 mRNA Vaccines for Research: The Re-emergence of the Tragedy of the ‘Anticommons’

Bill of Health

For instance, a study conducted in 2005 by the American Association for Advancement of Sciences revealed that 40% of respondents reported problems securing licenses for carrying out research; 58% reported delays due to licensing requirements; and 28% reported abandoning their research due to licensing issues.

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