In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni receive new funding, achieve regulatory approvals, appoint new executives, earn patents, and much more on the road to LSI USA ‘27 in Dana Point (March 15 - 19).
Received FDA 510(k) clearance for its AI-powered Aevice Wheeze Detection Module. The module identifies recordings with sounds suggestive of wheeze, giving care teams an additional tool to assess lung sounds captured outside scheduled visits.
Secured a Canadian patent protecting its catheter-based technologies for intraluminal systems that access nerves and tissues outside the vessel wall. The patent covers deployable probes and multi-site electrophysiological sensing and signal-processing techniques designed to monitor neural activity and verify procedural outcomes and treatment completion.
Granted FDA Breakthrough Device Designation to the HeartBeam System as a tool for assessing potential heart attacks outside of a healthcare setting. The designation recognizes the potential of its 3D ECG technology, which captures the heart’s electrical signals from three non-coplanar dimensions, to enable physicians to evaluate signs of a possible heart attack when symptoms start, wherever the patient may be.
Received FDA 510(k) clearance for its newest ultra-lightweight, highly flexible, high-density MRI receive coil for Philips 1.5T MRI systems. With this clearance, the company is expanding its flexible MRI coil technology to Philips 1.5T systems, significantly increasing the number of MRI systems and patients that can benefit from the technology.
Completed an oversubscribed $125M Series D financing round led by BioStar Capital, with participation from new investors S3 Ventures, Angelini Ventures, a strategic corporate investor, and existing investors. The funding will accelerate the global commercial growth of the Symani Surgical System.
Received FDA IDE approval for the STROKE-REWIRE pivotal study evaluating the investigational ReWire system in patients with chronic ischemic stroke. The miniaturized, wireless, battery-free implant uses closed-loop technology to pair vagus nerve stimulation with successful rehabilitation movements, strengthening neural pathways to support recovery of arm and hand function.
Received an investment from Brightlands Venture Partners (BVP) to support its U.S. clinical and regulatory program, anchored by the recently initiated VOICE-HF pivotal trial. The investment will also support expansion of the company’s commercial base in Europe.
Announced the first successful use of the SteriCISION® C-Section Retractor in patients undergoing caesarean section, with five infants successfully delivered during the company’s first-in-woman clinical investigation. The study has completed patient enrollment and met its pre-specified primary endpoints, supporting further evaluation of the device designed specifically for caesarean surgery.
Announced a commercial agreement with a major, undisclosed U.S. supplier of robotic-assisted and minimally invasive surgical tools, with the first phase now live at the company’s Phoenix facility. The agreement will initially involve nano-polishing the supplier’s devices, followed by full integration of the technology into the supplier’s manufacturing line, scheduled for 2027.
Achieved its enrollment target in the NANOPULSE-AF study, enrolling 164 evaluable patients across 15 clinical sites. The prospective, multicenter, non-randomized IDE pivotal study is evaluating the safety and effectiveness of the nPulse Cardiac Catheter System in patients with drug-resistant, symptomatic, paroxysmal atrial fibrillation.
Appointed Andy Sutcliffe as Vice President, Strategic Marketing, bringing more than 30 years of international healthcare experience across medical devices, orthopaedics, infection prevention, haemostasis, women’s health, and commercial strategy. Sutcliffe most recently served as Global Strategic Marketing Director at CELOX Medical, leading global commercialization and strategic marketing while overseeing the women’s health business with full P&L responsibility.
Announced that the first U.S. patients were treated with the ECLIPSIUM® System as part of the UNITE clinical trial. The study will evaluate the safety and effectiveness of ECLIPSIUM compared with resorbable mesh fixation, supporting the development of an atraumatic approach to hernia repair.
Received AMA CPT Editorial Panel approval for a new Category I CPT code for non-invasive localization of ventricular arrhythmias using 12-lead ECG data. This milestone supports the company’s Medical’s vMap®, the only FDA-cleared technology using standard 12-lead ECG data to localize arrhythmia sources across all four heart chambers.
Stay tuned for more updates, insights, and achievements of our LSI Alumni in The Weekly Recap, and follow our blog for the latest medical device news and advancements.
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