Agency reports concerns amid an increase in submitted data that has been fabricated, duplicated, or unreliable from third-party laboratories.
DELFI-Tumor Fraction assay was developed to improve noninvasive assessment of tumor burden and monitoring of treatment efficacy and resistance in patients with advanced cancers.
Tumor-treating fields therapy uses alternating electric fields of intermediate frequency and low intensity to disrupt processes critical in the survival of cancer cells.
Patients with the HeartMate 3 heart pump for advanced heart failure not taking aspirin as part of their blood-thinning medication regimen had fewer complications from bleeding with lower hospital visits.
PD-L1 IHC 22C3 pharmD approved to help identify patients who may be eligible to receive treatment with pembrolizumab (Keytruda) to treat gastric or gastroesophageal junction adenocarcinoma.
The Elecsys NfL test is designed to aid in detecting disease activity and to offer insights in disease management for patients with multiple sclerosis.
The newly approved Alinity m high risk human papillomavirus (HPV) assay is indicated to detect HPV and for use in routine cervical cancer screening per professional medical guidelines.
The continued development of more convenient VR technology has improved usability, accessibility, and affordability across healthcare settings.