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FDA, Pulse oximetry

FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones

Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now the US Food and Drug Administration is proposing guidance to help make these devices more reliable and less biased.

U.S. News & World Report · 1d

FDA Calls for Better Accuracy of Pulse Oximeters in People of Color

Pulse oximeters -- those tiny devices that measure blood oxygen levels with a quick clip to your finger -- may soon get a major upgrade to ensure they work just as well for people of all skin tones. The U.

WESH · 1d

Pulse oximeters may misread oxygen levels in people of color. The FDA wants to change that

Makers of medical devices that quickly measure oxygen levels in the blood would have to gather extra data to show that their products work for patients of color.

Scripps News on MSN · 1d

FDA calling on pulse oximeter makers to make life-saving changes to devices

Pulse oximeters help doctors evaluate a person's pulse rate and the oxygen saturation of your blood. The FDA is proposing changes to make them more accurate.

RSV, FDA and GSK

Hosted on MSN · 20h

FDA Adds Guillain-Barre Syndrome Warning to Two RSV Vaccines

Before the RSV vaccines were approved, the FDA flagged potential GBS risks with the vaccines. After approval, the CDC continued to monitor for GBS risk. FDA conducted a postmarket

Business Insider · 23h

GSK, Pfizer RSV vaccines to carry warnings of GBS, Reuters reports

GSK (GSK) and Pfizer (PFE) vaccines for respiratory syncytial virus, or RSV, will carry warnings that they can increase the risk of developing

Yahoo · 1d

FDA adds warning to RSV shots from GSK, Pfizer

Barré syndrome, although it said data don’t prove a causal link and affirmed the shots’ benefit outweighs their risks.

FDA Sets Lead Limits for Processed Baby Foods

CBS News · 2d

FDA sets limits on lead in some baby foods

But consumer advocates say the Food and Drug Administration's new guidance on lead limit in baby food doesn't go far enough.

U.S. News & World Report · 1d

Health Advocates Are Unhappy with FDA Guidance on Lead Levels in Baby Food

TUESDAY, Jan. 7, 2025 (HealthDay News) -- The U.S. Food and Drug Association (FDA) released the first-ever guidelines for levels of lead in processed baby foods this week. However, many health and safety advocates say they are not satisfied with the guidance.

LA Times on MSN · 1d

FDA sets limits for lead in many baby foods as California disclosure law takes effect

The FDA has set maximum levels for lead in baby food. A new California law requires baby food makers selling products in the state to disclose levels of four heavy metals.

22hon MSN

Healthy Returns: The FDA approved fewer new drugs in 2024 — but some big ones hit the market

The FDA wrapped up 2024 with 50 new drug approvals, clearing a wave of long-awaited treatments. Meanwhile, Transcarent will ...

STAT15h

Leaving FDA, Califf is unapologetic — and warns of staff departures

In an interview, outgoing FDA commissioner Robert Califf was wary of the Trump administration but unapologetic about ...

1don MSN

Biden FDA moves forward with rule to lower nicotine in cigarettes, a ‘gift’ to cartels, critic says

Opponents argue that the change could cause current smokers to use more cigarettes to compensate for the lower nicotine ...

2don MSN

FDA Pushes to Improve Blood Oxygen Monitor Accuracy Across Skin Tones

The FDA's draft recommendations for pulse oximeters aims to include clinical studies involving at least 150 participants with ...

STAT4h

FDA pushes makers of AI devices to disclose more details on testing, performance

The FDA wants the developers of medical devices that rely on AI to disclose more detail about how their devices were ...

FDA weighs novel pain drug amid opioid crisis

The FDA will decide later this month whether to approve a novel drug for acute pain that could offer a nonaddictive ...

FDA recommends fixing racial disparities in pulse oximeter readings

The Food and Drug Administration on Monday proposed a long-awaited plan aimed at improving how pulse oximeters work on people ...

2don MSN

Cheese Puffs Recall as FDA Issues Risk Warning

The snacks were distributed in the state of New York and have been recalled due to undeclared additives and flavor enhancers.

10hon MSN

FDA approves Bismarck doctor's new catheter design

When Dr. Bruce Gardner saw first-hand how much harm a forcefully-pulled catheter can do to a patient, he decided to take ...

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FDA, Pulse oximetry

RSV, FDA and GSK

FDA Sets Lead Limits for Processed Baby Foods

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