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Spectrumedics Announces CE Mark Approval For Its Coronary Intravascular Lithotripsy System

SINGAPORE, Jan. 6, 2026 /PRNewswire/ — Spectrumedics Medical (hereinafter “Spectrumedics”) is pleased to announce that its Sonico-CX Intravascular Lithotripsy (IVL) System has obtained CE Mark certification under the European Union Medical Device Regulation (EU MDR). The system comprises the Sonico-CX Coronary Intravascular Lithotripsy Catheter and the Intravascular Lithotripsy Generator.

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Neurolief receives FDA PMA Approval for First At-Home Brain Neuromodulation Therapy for Adults Whose Depression Was Not Adequately Improved by Antidepressants 

CORAL SPRINGS, Fla., Jan. 12, 2026 /PRNewswire/ — Neurolief Inc., a medical device company focused on neuromodulation therapies for neuropsychiatric conditions, today announced that the U.S. Food and Drug Administration (FDA) has approved Proliv™Rx, the first prescription, physician-directed, at-home brain neuromodulation therapy as an adjunctive treatment for adults with Major Depressive Disorder (MDD) who failed to achieve satisfactory improvement from at least one previous antidepressant medication.

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