The surgical solutions business that Medline will acquire, which includes the Microtek product lines, generated more than $400 million in sales in 2023, Ecolab said.

Analysts said the designation and planned one-year sensor could help Senseonics’ device appeal to more patients.

The test would determine if patients are eligible for Pfizer’s new hemophilia B treatment by detecting if they have been exposed to a virus that could make the gene therapy less effective.

The new policy aims to ensure important diagnostics remain available to patients, but some experts caution the increased regulatory burdens could slow access to testing.

While RBC analysts wrote there’s “strong appetite” for the system, BTIG said the need to train centers could result in a “gradual” launch.

Risks associated with the tests have increased, requiring greater oversight to protect patients, the agency contends.

Saluda Medical received FDA approval for a closed-loop device in 2022 but the big, publicly traded SCS companies have only provided open-loop systems. Medtronic said it will launch Inceptiv in the U.S ...

Endomagnetics, which makes guidance technology for breast cancer surgery, brought in about $35 million in revenue last year.

Medtronic’s latest layoff plan adds to what has become a long list of job cuts for the medical device industry this year.

Livanova learned that an unauthorized party obtained patient data, including Social Security numbers and health conditions, during last year’s attack.

New mitral and tricuspid valve treatments are attracting strong demand, but analysts said transcatheter aortic valve replacement sales were shy of expectations.

Nearly 2.2 million devices are affected by the recall. Fresenius Medical Care will not have to remove products due to the issue.