LSI Alumni companies keep pushing the limits of medical technology and healthcare innovation with new FDA clearances, clinical achievements, investments, and commercial partnerships. This week’s LSI MedTech news features advances in cardiac care, surgical robotics, diagnostic imaging, neurological rehabilitation, and others that are influencing the future of healthcare.
Here are the most recent updates from the LSI Alumni community as the industry gets ready for LSI USA in Dana Point, California on March 15-19, 2027.
Regulatory Approvals and Clinical Milestones is an acronym for RAM.Regulatory Approvals and Clinical Milestones is RAM.
Aevice Health
Aevice Health’s AI-based Aevice Wheeze Detection Module has been FDA 510(k) cleared. The technology is used to detect sounds indicating wheezes in recordings outside of the scheduled clinical visit, giving care teams an extra instrument to use to evaluate lung sounds.
HeartBeam
The HeartBeam System has been FDA Breakthrough Device Designated to aid in the evaluation of heart attacks in non-clinical environments. The 3D ECG technology is used to capture the electrical signals of the heart from three non-coplanar dimensions, to assist physicians in assessing possible heart attack symptoms at the onset.
InkSpace Imaging
InkSpace Imaging has won FDA 510(k) clearance for its new ultra-lightweight, flexible and high-density receive coil for Philips 1.5T MRI systems. The clearance adds to the range of flexibility that the company has in its MRI coil technology, and may open up the MRI system’s patient population and expand its reach to other MRI systems.
NeuWire Medical
NeuWire Medical is the first company to be granted FDA Investigational Device Exemption (IDE) approval for the pivotal STROKE-REWIRE study. The investigational ReWire system will be assessed during the trial in the patients with chronic ischemic stroke.
Closed-loop technology has been used to match successful rehab movements with vagus nerve stimulation in the miniaturized, wireless, and battery-free implant. The technique is aimed at consolidating neural networks and aiding in the improvement of arm and hand function.
Pulse Biosciences
Pulse Biosciences met its enrollment goals in the NANOPULSE-AF study with the enrollment of 164 evaluable patients in 15 clinical sites. The IDE pivotal study is a prospective, multicenter, nonrandomized study that will assess the safety and effectiveness of the nPulse Cardiac Catheter System for treating drug-resistant, symptomatic paroxysmal atrial fibrillation.
TISSIUM
TISSIUM announced the first patients had been treated with the ECLIPSIUM® System in the UNITE clinical trial in the U.S. The study will assess the safety and effectiveness of the system vs resorbable mesh fixation, which will help develop an atraumatic approach to hernia repair.
Vektor Medical
Vektor Medical has been approved by the American Medical Association (AMA) CPT Editorial Panel for a new Category I CPT code for noninvasive localization of ventricular arrhythmias based on 12-lead ECG data.
The milestone also advances the company’s vMap® technology, which is based on standard 12-lead ECGs to visualize the location of sources of arrhythmias in all four heart chambers.
Funding and Commercial Growth
MMI – Medical Microinstruments
BioStar Capital led an oversubscribed $125 Million Series D round for Medical Microinstruments (MMI). New investors S3 Ventures and Angelini Ventures, a strategic corporate investor and existing investors were all participants.
The investment will help the company launch its Symani Surgical System commercially around the world.The investment will be used to advance the company’s Symani Surgical System for global commercialisation.
Noah Labs
Brightlands Venture Partners (BVP) has provided an investment to support the clinical and regulatory program in the U.S. of Noah Labs, which is based on the recently launched VOICE-HF pivotal trial. The investment will also support the company’s expansion in Europe’s business.
Planatome
Planatome also announced a commercial agreement with an undisclosed large U.S. supplier of robotic-assisted and minimally invasive surgical tools. The supplier’s Phoenix facility is the location for the first phase of the agreement, which is now active.
The first part will be dedicated to the nano-polishing of the supplier’s devices. A second stage will involve Planatome’s technology becoming part of the supplier’s production process and is expected to be implemented by 2027.
Patents and Technology Development.
Autonomix Medical
Autonomix Medical has been granted a Canadian patent for its catheter-based technologies for intraluminal systems to access nerves and tissues outside the vessel wall.
The patent includes deployable probes, multisite electrophysiological sensing, and signal-processing methods for neural sensing and confirming procedural results and therapeutic completion.
The leadership and commercial expansion.Leadership and commercial expansion.
STIMVIA
STIMVIA hired Andy Sutcliffe to become Vice President of Strategic Marketing. Sutcliffe has over 30 years international healthcare experience in the medical devices, orthopaedics, infection prevention, haemostasis, women’s health and commercial strategy sectors.
He has recently been Global Strategic Marketing Director at CELOX Medical, where he has spearheaded strategic marketing and commercialization across the globe, and managed the women’s health business unit with full P&L accountability.
The development of surgical innovations and clinical advances.Advancements in surgical areas and progress.
NUA Surgical
NUA Surgical announced the first successful use in patients of its SteriCISION® C-Section Retractor for caesarean section. The company has performed the first-in-woman clinical study with five infants and successfully delivered them.
Patient enrolment in the study is now complete and the prespecified primary endpoints have been met, indicating the device is suitable for further evaluation, and was designed specifically for caesarean surgery.
Read about the latest updates from LSI Alumni.
These are just some of the examples of innovation within the LSI Alumni community from regulatory milestones to clinical research, new investments, new IP, and new commercial partnerships.
Follow The Weekly Recap for more information about the companies, technologies and industry developments that could impact the future of MedTech and HealthTech. While the medical device community waits for LSI USA ’27, tune into the LSI blog for the latest in medical device news and insights.