US FDA Attempts To Parse Sex Vs. Gender, But Will Politics Interfere?

The draft guidance clarifies that sex and gender are not interchangeable, but could be vulnerable in the Trump Administration as Republicans have argued against transgender medical care and that sex and gender must be congruent.

Female and male sex symbols on pink and blue blocks
(Chawalit Banpot/Shutterstock)

A new US Food and Drug Administration draft guidance clarifies the difference between sex and gender, acknowledging the agency has often used the terms interchangeably and imprecisely in the past.

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Research Finds Benefit From DME Suppliers For People Living With Diabetes

 
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People living with diabetes who receive continuous glucose monitors (CGMs) through medical supply firms show higher compliance, lower costs of care, and fewer hospitalizations after one year than those who use pharmacies, a new study shows.

EU Commissioner: Medtech Regulations Assessment To Wrap Up by End 2025

 

Pediatric devices and IVDs are to be a priority. And the European Health Data Space regulation is seen as critical in supporting digital technologies and AI in transforming care.

Owlstone Medical Develops P.aeruginosa Breath Test For Cystic Fibrosis Patients

 

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US FDA Should Regulate ‘Dangerous’ Prescription Software Platform As A Medical Device, Says Patient Advocacy Group

The Doctor Patient Forum says the US FDA should regulate a scoring platform from Bamboo Health intended to help clinicians calculate risk for opioid abuse as a medical device to ensure patient safety.

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FDA Guidance Docs On Trial Diversity, Sex Differences Restored After Court Order

 
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A federal judge granted Doctors for America’s motion for a temporary restraining order directing the FDA and CDC to restore information removed from the agencies’ websites to comply with a presidential executive order targeting “gender ideology extremism.”

What’s The Scope Of Endoscope Risk?

 

For the fourth time in as many years the FDA has issued a communication concerning a key accessory from Olympus used in several types of urological procedures. This time, however, the agency has added a class I recall confirmation to its original early alert on the device issued in December 2024. A device safety specialist provided Medtech Insight with a deeper understanding of the problem as well as overall scope safety.

Global Medtech Guidance Tracker: January 2025

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 80 documents have been posted on the tracker since its last update.