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Genesis MedTech announces FDA Breakthrough Device designation for the J-Valve Transfemoral System
Genesis MedTech, a leading medical device company, today announced that its J-Valve™ Transfemoral (TF) System has been granted Breakthrough Device designation…
Francis Medical Receives US FDA Breakthrough Device Designation for Vanquish Minimally Invasive Prostate Cancer Therapy
Francis Medical, Inc., a privately held medical device company developing an innovative and proprietary water vapor ablation therapy for the…
Imeka receives FDA 510(k) clearance for ANDI imaging software
Canada-based neuroimaging firm Imeka has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Advanced Neuro…
SEKISUI Diagnostics unveils OSOM Covid-19 antigen home test
SEKISUI Diagnostics, a US-based medical diagnostics solutions provider, has unveiled its OSOM Covid-19 antigen home test to diagnose Covid-19 at…
FDA Clears Numares Health Cardiovascular Diagnostic Test and Core Technology Platform
The US Food and Drug Administration has cleared a Numares Health test, the AXINON LDL-p Test System, as a new…
Anteris Technologies Announces First Successful Implantation of DurAVR THV in a Valve-in-Valve Procedure
Anteris Technologies, a structural heart company developing DurAVR THV, a new class of biomimetic heart valve and the world’s only…
Natera concludes enrolment in Phase 3 Signatera test trial in CRC patients
Natera has completed the enrolment in the Phase 3 ALTAIR clinical trial of the Signatera molecular residual disease (MRD) test…
RetinalGeniX secures patent for home monitoring and alert system
US-based medical device company RetinalGeniX Technologies has secured a patent for its Patient Home Monitoring and Integrated Physician Alert System…
New Data from Clinical Studies Further Validate HeartFlows All-in-One Portfolio of Precision Coronary Care Solutions
Respective results from the REVEALPLAQUE, DECODE, and SMART-CT clinical studies demonstrate the accuracy, utility, and efficiency of HeartFlow’s portfolio of…
Palliare Announces EU CE Mark Approval Under New Medical Devices Regulation
Palliare, a leading developer of advanced insufflation technologies, has received EU CE Mark certification under the new EU Medical Devices…