The FDA has cleared its first completely at-home sexual health test for women, available over-the-counter to screen for ...
Diagnostics' Q4 2024 earnings insights, FDA resubmissions, TB & HPV test pipelines, and international market growth plans.
The FDA recently approved the first treatment in nearly 30 years for acute stroke, and the agency also approved a novel drug ...
SAN DIEGO – Dexcom has received a warning letter from the U.S. Food and Drug Administration regarding “non-conformities” in manufacturing and quality processes after inspections of its facilities ...
Medical Device Network on MSN1d
MedCAD secures FDA 510(k) clearance for AccuStride foot and ankle systemThe AccuStride System is intended to enhance surgical outcomes for proximal phalanx and metatarsal arthroplasty.
Ossera™ AFX Ankle Fusion System: Newly FDA 510 (k) cleared, Ossera™ AFX is a breakthrough 3D-printed fusion system featuring TIDAL Technology™, engineered for optimized osseointegration and ...
From regulatory clearances to partnerships, here are five key developments from spine and orthopedic medtech companies since ...
Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, ...
The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical ...
“Unlike traditional ACL reconstruction, which sacrifices healthy tissue and can lead to long-term issues like muscle weakness ...
Aurora Spine earned FDA 510(k) clearance for its Aero facet fusion system, the devicemaker said March 25. Aero is a minimally ...
In an agency first, the FDA has cleared a system designed to clean out the complex inner channels of flexible endoscopes—a ...
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