FDA Issues Cautionary Reminder to Medical Device Manufacturers Regarding Data Submitted from Third-Party Laboratories
Agency reports concerns amid an increase in submitted data that has been fabricated, duplicated, or unreliable from third-party laboratories.
FDA Advisory Committee Endorses Abbott's TriClip System
Device designed to address tricuspid regurgitation through a vein in the leg.
Synchron Advances Efforts to Develop Brain-Computer Interface
Synchron’s brain-computer interface device is being developed to allow patients with mobility challenges to operate certain technology with their mind.
DELFI Diagnostics Launches Assay That May Improve Monitoring of Cancer Treatment Response
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.
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