The new therapy, made from the pancreatic cells of deceased donors, is designed to help adult type 1 diabetes with severe hypoglycemia go a year or longer without needing to take insulin. 

The FDA has said this is a Class I recall, which means using the devices “may cause serious injuries or death.” A total of 18 injuries have been reported so far. 

"The FDA's approval of colchicine confirms that we are entering a new era of patient care," said one veteran cardiologist familiar with the drug. 

Anumana, Pfizer and Mayo Clinic all worked together to develop the advanced algorithm. The groups are now targeting full regulatory approval in the U.S., Europe and Japan.

The new device was designed to remove thrombi and emboli from peripheral arteries ranging from 2 to 4 mm. 

Multiple medical devices used during cardiopulmonary bypass and extracorporeal membrane oxygenation procedures have been voluntarily recalled due to issues with their packaging.

Malissa Wood, MD, associate chief of cardiology for diversity and equity at Massachusetts General Hospital, explains the role of health equity in cardiovascular care and what her health system is doing to address it. 

The device, now on display at TVT 2023 in Phoenix, is scheduled to begin hitting the market in the months ahead.