Hacker News with Generative AI: FDA

After decades, FDA moves to pull ineffective decongestant off shelves (arstechnica.com)
In a long-sought move, the Food and Drug Administration on Thursday formally began the process of abandoning oral doses of a common over-the-counter decongestant, which the agency concluded last year is not effective at relieving stuffy noses.

Health, FDA, Pharmaceuticals, Over-the-Counter Medications

299 points by coloneltcb 13 days ago | 3 comments

FDA proposes ending use of oral phenylephrine as OTC nasal decongestant (fda.gov)
Today, the U.S. Food and Drug Administration announced it is proposing to remove oral phenylephrine as an active ingredient that can be used in over-the-counter (OTC) monograph drug products for the temporary relief of nasal congestion after an agency review of the available data determined that oral phenylephrine is not effective for this use.

FDA, Pharmaceuticals, Health, Regulations, Nasal Congestion

303 points by impish9208 13 days ago | 507 comments

FDA Permits Marketing of Digital Game to Improve Attention in ADHD Children (2020) (fda.gov)
Today, the U.S. Food and Drug Administration (FDA) permitted marketing of the first game-based digital therapeutic device to improve attention function in children with attention deficit hyperactivity disorder (ADHD).

Gaming, Health, ADHD, FDA, Digital Therapeutics

41 points by luu 21 days ago | 19 comments

The science behind on-the-wrist blood pressure tracking (empirical.health)
There are many rumors that an upcoming Apple Watch will measure blood pressure; similar features exist on Samsung watches internationally and are likely to come to the US once cleared by the FDA.

Health, Wearable Technology, Apple, Samsung, FDA

156 points by brandonb 42 days ago | 105 comments

No needles required: The FDA approves an at-home flu vaccine (npr.org)
The Food and Drug Administration has approved the first flu vaccine that people can administer to themselves at home.

Health, Pharmaceuticals, Vaccines, FDA

7 points by tambourine_man 61 days ago | 0 comments

The FDA approves an at-home nasal spray flu vaccine (npr.org)
The Food and Drug Administration has approved the first flu vaccine that people can administer to themselves at home.

Health, Vaccines, Flu, FDA

6 points by geox 61 days ago | 0 comments

FDA approves nasal flu vaccine for at-home use (nytimes.com)
The Food and Drug Administration on Friday authorized at-home use of FluMist, opening the door for needle-shy people to have easy access to a nasal spray vaccine that is potentially lifesaving.

Health, Medicine, Vaccines, FDA, Flu

29 points by anigbrowl 62 days ago | 1 comments

Neuralink Received Breakthrough Device Designation from the FDA for Blindsight (twitter.com)

Neuralink, FDA, Medical Technology, Blindness, Neuroscience

12 points by marc__1 65 days ago | 4 comments

Apple Watch sleep apnea detection gets FDA approval (techcrunch.com)
The US Food and Drug Administration Monday published approval for sleep apnea detection on the Apple Watch Series 9, Series 10, and Watch Ultra 2.

Health, Wearables, FDA, Apple, Sleep Apnea

464 points by brandonb 66 days ago | 316 comments

FDA Authorizes First Over-the-Counter Hearing Aid Software (fda.gov)
Today, the U.S. Food and Drug Administration authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple AirPods Pro headphones.

FDA, Hearing Aids, Technology, Health, Apple

438 points by mgerdts 69 days ago | 240 comments

Apple just got FDA approval for AirPods Pro 2's hearing aid feature (9to5mac.com)
Earlier this week, Apple announced a powerful new health feature coming to AirPods Pro 2: hearing aid. But curiously, the company shared that it had not yet received FDA approval for this ‘clinical grade’ hearing aid mode. Assuming that would happen, though, the feature would arrive later this year. As of today, however, the FDA announced it has officially approved Apple’s new feature.

Health, Consumer Electronics, Apple, FDA

6 points by alwillis 70 days ago | 0 comments

Many FDA-approved AI medical devices are not trained on real patient data (medicalxpress.com)

AI, Medical Devices, FDA, Healthcare, Data

82 points by clumsysmurf 86 days ago | 61 comments

MDMA therapy didn't get FDA approval. Now what? (vox.com)

Mental Health, Medicine, FDA

8 points by ojarow 103 days ago | 0 comments

FDA is regulating patients to death (bessstillman.substack.com)

FDA, Healthcare, Regulation, Death

9 points by vinnyvichy 107 days ago | 2 comments

FDA sued for ignoring evidence that anti-depressants numb genitals permanently (dailymail.co.uk)