MPO’s Most-Read Stories This Week—July 22

Product news—good or bad—topped MPO website pageviews this past week.

Leading the way was Magnus Medical Inc. with its promising clinical trial results showing treatment with its SAINT Neuromodulation reverses abnormal brain signaling by changing the direction of brain signal flow in people with severe depression. Findings also reveal a new biomarker that may be helpful in the diagnosis and treatment of major depressive disorder. 

Siemens Healthineers and Reddyport drove traffic with regulatory clearances, while Medtronic made cyberwaves with its Class I recall.

The FDA granted Breakthrough Device Designation to Siemens’ Enhanced Liver Fibrosis (ELF) Test1 and 510(k) clearance to ReddyPort’s elbow device for non-invasive ventilation. 

Medtronic, not surprisingly, gained (unwanted?) attention after the FDA deemed the May 10 recall as Class I for all implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured after 2017. The recall covers the following devices distributed between Oct. 13, 2017, and June 9, 2023: Cobalt XT, Cobalt, Crome ICDs and CRT-Ds; Claria MRI, Amplia MRI, Compia MRI, Viva, Brava CRT-Ds; and Visia AF, Visia AF MRI, Evera, Evera MRI, Primo MRI, Mirro MRI ICDs.

1. Study: Magnus Medical Depression Treatment Changes Abnormal Brain Signals

2. FDA Grants Breakthrough Device Designation for Siemens Healthineers’ Enhanced Liver Fibrosis Test

3. Medtronic Recalls ICDs, CRT-Ds Over Energy Output Issue

4. Preserve and Protect: Sustainability Initiatives for Medtech Manufacturing

5. FDA OKs ReddyPort Non-Invasive Ventilation Device