Roche’s PATHWAY HER2 (4B5) test helps identify patients with HER2-ultralow breast cancer, who may be eligible for targeted ...
What will the industry face or achieve in 2025? These trends will be critical in medical device cybersecurity.
HeartBeam has submitted a 510(k) application to the US Food and Drug Administration (FDA) for its 12-lead electrocardiogram ...
"FDA grants 510(k) clearance to GE HealthCare’s updated ultrasound systems" was originally created and published by Medical ...
Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were ...