Big Changes Are Likely Coming For Pulse Oximeters, FDA Hints

Nature: Crackdown On Skin Colour Bias By Fingertip Oxygen Sensors Is Coming, Hints FDA
The US Food and Drug Administration (FDA) plans to propose that companies conduct more stringent evaluation of the devices, called pulse oximeters, before applying for agency approval. The proposal, which the agency has not yet formally announced, calls on manufacturers to increase the devices’ accuracy and to boost the number of people on which the devices are tested. The agency also wants companies to test the devices on people whose skin colours span the entire range of a specific colour scale. FDA scientists presented the proposal at a meeting of an independent advisory committee on 2 February. (Kozlov, 2/2)

Stat: Quicker Fix For Pulse Oximeters Urged During FDA Public Meeting 
The Food and Drug Administration should move more quickly to ensure pulse oximeters — the ubiquitous devices used to measure blood oxygen — work well in all patients, should better inform clinicians about the devices’ shortcomings in patients with darker skin, and should recall versions that are particularly problematic, patients, researchers, and consumer advocates testified during a public meeting on Friday. (McFarling, 2/2)

In other news about the FDA —

Fox News: To Fight Bone Loss, FDA Approves Vibration Belt Shown To Help Post-Menopausal Women
The U.S. Food and Drug Administration (FDA) recently granted clearance for a vibration belt known as Osteoboost. ... "A study conducted at the University of Nebraska Medical Center showed the efficacy of Osteoboost in directly stimulating bone growth and preserving bone mineral density and strength in postmenopausal women with osteopenia by sending low-frequency vibrations directly to the lumbar spine and hips," Laura Yecies, CEO of Bone Health Technologies in Redwood City, California, told Fox News Digital. (Sudhakar, 2/4)

Stat: Congress Might Make Insulin Pumps More Accessible To The Blind
Digital home devices are in a regulatory gray area when it comes to accessibility standards. No agency requires manufacturers to incorporate features for blind folks. Advocates from the National Federation of the Blind have lobbied lawmakers for years to fix this. Now, federal lawmakers have introduced a bill that would require the Food and Drug Administration to develop rules mandating device makers build accessible products. Insulin pumps and glucose monitors are a critical focus, as diabetes is one of the leading causes of blindness in the United States. But the bill would also direct the FDA to cover devices like CPAP machines or heart monitors. (Lawrence, 2/5)

In related government news —

Bloomberg: CDC Opens Office In Tokyo As US Seeks To Shore Up Political Allies
The US Centers for Disease Control and Prevention is opening its first regional office in a developed nation, with the post in Japan set to enhance its work with allies on disease monitoring amid rising geopolitical tensions with China. “This region is incredibly important,” CDC Director Mandy Cohen said in an interview in Tokyo on Monday. “It’s where a number of emerging infectious diseases have come from prior and so it’s important for us to be able to share information quickly to jointly invest in health security platforms and capacity.” (Matsuyama, 2/5)

KFF Health News: Journalists Catch Up On Top Issues Facing 2024 Voters, From Obamacare To Opioids 
KFF Health News’ chief Washington correspondent, Julie Rovner, discussed the record enrollment in Affordable Care Act health plans on C-SPAN’s “Washington Journal” on Jan. 30. Rovner also discussed health care issues against the backdrop of the 2024 election on Wisconsin Public Radio’s “Central Time” on Jan. 25. ... KFF Health News Montana correspondent Katheryn Houghton discussed Montana’s opioid settlement money on Montana Public Radio on Jan. 23. (2/3)