Stereotaxis has won FDA approval for its robotically navigated MAGiC ablation catheter, offering a minimally invasive option for patients who otherwise might not be...
Spectrumedics Medical has obtained a CE mark for its coronary intravascular lithotripsy (IVL) system under the European Union’s Medical Device Regulation (EU MDR).
Related: StimLabs...
StimLabs announces that the U.S. Food & Drug Administration (FDA) has granted 510(k) clearance for Theracor, the first human umbilical cord-derived medical device to...
SleepRes announced that it received FDA 510(k) clearance for its Kricket PAP device for treating obstructive sleep apnea (OSA).
Kricket PAP is powered by the...
CMR Surgical has secured US Food and Drug Administration (FDA) clearance for its Versius Plus minimally invasive robotic surgical system, priming the company to...
Medivis announced today that it received FDA 510(k) clearance for its augmented reality (AR)-powered Cranial Navigation platform.
The company said clearance makes Cranial Navigation the...
France-based May Health has secured a European CE mark for its Anavi system to address infertility in women with polycystic ovary syndrome (PCOS).
The system...
The Food and Drug Administration (FDA) has granted 510(k) clearance for Vesalio’s enVast clot retriever, paving the way for its commercial launch in the...
The FDA has granted Breakthrough Device Designation to Nephrodite’s Holly implantable continuous dialysis system.
In an exclusive interview ahead of the official announcement, Nephrodite co-founder...