Cue has gone through several rounds of layoffs as the testing company looks to control costs. In January, the company cut more than 200 positions across two rounds of layoffs, and Cue also slashed ...

The Food and Drug Administration’s final rule solidifying its authority over laboratory developed tests (LDTs) marks a major shift in the regulation of the diagnostics industry. The rule makes clear ...

AVer Information Inc. USA, the award-winning provider of education technology and video collaboration solutions, will ...

Ascelia Pharma AB (publ) (ticker: ACE), a biotech focused on improving the life of people living with rare cancer conditions, ...

A judge recently finalized an economic claims settlement, and Philips said it reached an agreement on medical claims.

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.

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

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.

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

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 ...