Onward Medical received FDA de novo clearance for its ARC-EX spinal cord stimulation (SCS) system. ARC-EX SCS therapy delivers targeted, programmed electrical stimulation transcutaneously...
HeartBeam has gained the US Food and Drug Administration’s 510(k) clearance for its comprehensive arrhythmia assessment system.
The patented high-fidelity electrocardiogram (ECG) HeartBeam device, distinguished...
Cercare Medical announced FDA clearance for its CT perfusion imaging software, a significant milestone that complements the existing clearance for MRI perfusion imaging. This...
Liquet Medical Inc., a pioneering medical device company committed to advancing patient care through innovative technologies, today announced it has received 510(k) clearance from...
FemPulse received FDA investigational device exemption (IDE) approval for its overactive bladder (OAB) therapy.
The company can now begin the EVANESCE II pivotal clinical trial...
SyntheticMR, a developer of quantitative imaging software, has gained FDA 510(k) clearance for its SyMRI 15 solution on diagnostic image replacement of conventional images.
SyMRI...
Vision RT announced CE mark certifications for three innovative products: MapRT ®, DoseRT® and the AlignRT Respiratory Module.
DoseRT is a treatment verification tool that...
Lungpacer Medical announced it received FDA premarket approval for its flagship AeroPace neurostimulation system. AeroPace uses neurostimulation via an electrode-containing cardiovascular catheter and a...
US-based Field Medical has secured breakthrough device designation from the US Food and Drug Administration (FDA) for the FieldForce ablation system.
FieldForce is the first...
