Shockwave Begins First All-Female Study Of Coronary Interventions

The EMPOWER CAD trial will evaluate Shockwave’s intravascular lithotripsy system in female patients undergoing a percutaneous coronary intervention for coronary artery disease. Principal investigator Alexandra Lansky spoke to Medtech Insight about the first-of-its kind study in this understudied population.

Heart Equity
• Source: Shutterstock

A new study sponsored from Shockwave Medical, which specializes in coronary intravascular lithotripsy (IVL), is designed to close the deadly gender gap in coronary artery disease (CAD).

More from Diversity & Inclusion

Drop Email Pronouns And Return To Work, Administration Orders FDA Staffers

 

Chaos continues at the FDA’s device center as reinstated staffers begin daily commutes to comply with the administration’s return to office policy. Staffers can no longer publicly share their pronouns per Trump’s “Defending Women” executive order.

Brooklyn Medtech Works To Bring Hospital-Level Care To Remote Areas

 
• By 

10XBeta is helping to develop a modular mobile health care platform as part of a federal initiative to improve the quality of care in rural areas. Company CEO Marcel Botha told Medtech Insight that the product fits the company’s goals of bringing treatment to the people who need it most.

AI Bias Page, Health Equity Discussion Paper Back On FDA Site

 

Two US FDA device center websites have been restored under a restraining order. The pages now carry a disclaimer alleging they include "extremely inaccurate" content about gender; however, neither site includes any substantive discussion of trans issues.

EU Public-Private Partnership Invests €66.8M To ‘Transform Clinical Studies’ By Boosting Diversity

 

A six-year project aiming to establish a “less fragmented and more democratic” approach to clinical studies has commenced in the EU.

More from ESG

EU Public-Private Partnership Invests €66.8M To ‘Transform Clinical Studies’ By Boosting Diversity

 

A six-year project aiming to establish a “less fragmented and more democratic” approach to clinical studies has commenced in the EU.

Are Downed DEI Pages Part Of Trump Executive Order Sweep, Or Just The Result Of Routine Transition?

 

Several pages on the US FDA website related to diversity and inclusion are down, which aligns with Trump’s recent executive order on diversity, equity, and inclusion. However, the Department of Health says there's been a “short pause” in communications to allow the incoming team to get in place.

CDRH Report: 24 Voluntary Diversity Action Plans Filed In 2024

 
• By 

While the US FDA will not require diversity action plans for clinical trials for a while, some companies are already sending them in, a new FDA report to Congress shows.