BD secures FDA 510(k) approval for BD MiniDraw capillary blood collection system
The BD MiniDraw capillary blood collection system is designed to provide lab-quality blood testing for the diagnosis of…
Mosie Baby gets FDA nod for at-home intravaginal insemination kit
08 Dec 23The over-the-counter Mosie Baby Kit is an at-home insemination kit designed for people who cannot conceive with intercourse…
AngioDynamics concludes patient enrolment in AlphaVac F18 System trial in PE treatment
08 Dec 23The single-arm Investigational Device Exemption APEX-AV study is intended to assess the efficacy and safety of the AlphaVac…
Ad Astra secures FDA 510(k) approval for QScout haematology analyser
08 Dec 23QScout system is designed to provide rapid, point-of-care (POC) white blood cell counts (WBCs), neutrophil-to-lymphocyte ratio, and differentiates…
BioPorto Receives FDA 510(k) Clearance for NGAL Test in the United States First Test to Aid in Assessing AKI Risk for Patients Aged 3 Months Through 21 Years
08 Dec 23BioPorto expects that US sales through its distribution agreement with Roche Diagnostics GmbH (Roche) will begin in the…
OSSIO secures FDA approval for OSSIOfiber bio-integrative fixation technology
07 Dec 23The OSSIOfiber intelligent bone regeneration technology is an implant material stronger than cortical bone that combines mechanical strength…
US FDA approves Bering’s AI-based chest X-ray triage solution
07 Dec 23The solution, dubbed BraveCX, is a radiological computer-assisted triage and notification software designed to analyse adult chest X-ray…
Biospectal gets CE Mark for OptiBP blood pressure monitoring app
07 Dec 23OptiBP uses the built-in camera lens on a smartphone to capture an individual’s blood flow and the captured…
Dexcom integrates Dexcom G7 CGM with Tandem’s t:slim X2 insulin pump
07 Dec 23The integration will allow users of t:slim X2 insulin pump to spend more time in closed loop with…
OtoNexus Medical Technologies Selected for Elite FDA STeP Program
07 Dec 23FDA STeP Program awarded to OtoNexus Medical Technologies for ultrasound platform technology that evaluates middle ear infections