The Weekly Recap 9/19/25: LSI Alumni Achievements Driving Medtech and Healthtech Forward

 In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni secure new funding, announce regulatory clearances, and much more on the road to LSI USA ’26 in Dana Point (March 17–21).

AccurKardia

Announced the launch of a multicenter clinical pilot for AK+ Guard™, its FDA Breakthrough Device Designated AI-powered technology for detecting hyperkalemia using Lead I ECG. The study will evaluate over 150 patients across care settings and aims to validate the platform’s ability to deliver real-time, remote monitoring through consumer and clinical wearables.

Amber Implants

Received FDA 510(k) clearance for its VCFixⓇ Spinal System, a minimally invasive vertebral augmentation device designed to treat vertebral compression fractures. One-year follow-up data from initial clinical trials showed sustained pain reduction and faster recovery, supporting Amber’s plan to begin its U.S. commercial launch with a pilot program in early 2026.

Argá Medtech

Enrolled the first patients in the COHERENT AF IDE clinical trial evaluating its Coherent Sine Burst Electroporation (CSE) System for atrial fibrillation. The study is designed to test the safety and effectiveness of the CSE System in patients with paroxysmal and persistent atrial fibrillation.

Axoft

Was awarded grant funding from Bpifrance through the Bourse French Tech Emergence program to advance preclinical development in Grenoble, France. The funding supports Axoft’s mission to build next-generation brain–computer interfaces for patients with neurological conditions.

Byonyks

Announced the issuance of a U.S. patent supporting its Bloodless Dialysis technology, a needle-free, non-invasive solution for kidney failure treatment. The milestone strengthens Byonyks’ intellectual property portfolio as it advances efforts to expand global access to affordable, at-home dialysis care.

This blog is originally published here: https://www.lifesciencemarketresearch.com/insights/the-weekly-recap-91925-lsi-alumni-achievements-driving-medtech-and-healthtech-forward

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