Officials will accept atrial fibrillation data collected by the wearable as a secondary endpoint in studies of cardiac ablation devices.

No one solution can match the scope and scale of ethylene oxide, but a “multi-pronged approach” can help reduce emissions, an FDA official said.

Karius plans to use the funding to expand the test outside of the hospital setting and support research of the company’s DNA technology beyond infectious diseases.

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.

AVer Information Inc. USA, the award-winning provider of education technology and video collaboration solutions, will introduce the MD120UI, a medical grade, feature-rich pan, tilt and zoom (PTZ) ...

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

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.

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.

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

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 ...