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 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.

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

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.

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

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 ...

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

Compared with a loss of 665 million euros in the year-ago period Philips said Monday it has agreed to pay $1.1 billion to settle U.S. personal injury litigation and a medical monitoring class action ...

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

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