In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni receive regulatory clearances, enter strategic partnerships, appoint new executives, and much more on the road to LSI Asia ‘25 in Singapore (June 10-13).
Appointed Dr. Amit Reches as its new Chief Technology Officer to advance its non-invasive cardiovascular diagnostics platform. Dr. Reches brings over 25 years of expertise in medical devices and technology, including leadership roles at Nuvo and Firefly Neuroscience, with proven experience in developing and commercializing FDA- and CE-approved products.
Appointed Todd Dunn as Chief Executive Officer to lead the company’s next phase of growth and innovation in acute kidney care. Dunn, previously Accuryn’s Chief Transformation Officer, brings extensive leadership experience from roles at Atrium Health, GE Healthcare, Cisco, Siemens, and McKesson, with a strong focus on hospital operations and technology integration.
Enrolled the first patient in its ASCEND-EV clinical study evaluating the Atala lead, an extravascular ICD lead system designed to deliver pacing and defibrillation without entering the heart or vasculature. Early cases successfully demonstrated sensing and defibrillation of induced ventricular fibrillation, with the company planning to expand the study to additional clinical sites.
Received FDA 510(k) clearance for brAIn™ SPS, a cloud-based AI-powered shoulder positioning system developed in collaboration with FX Shoulder Solutions. The brAIn SPS offers advanced 3D visualization of both bone structures and soft tissues, enhancing surgical planning accuracy and improving patient outcomes in shoulder arthroplasty.
Appointed Dr. Chris Springer to its Board of Directors to support the commercialization of the Moda-flx Hemodialysis System. Dr. Springer brings 30 years of strategic and commercial expertise from his leadership roles at Vifor Pharma and Amgen, enhancing Diality’s growth strategy as it prepares for market entry.
Announced the acquisition of its DEXTER® Robotic Surgery System by Northtowns Ambulatory Surgery Center (ASC), the first ASC in the United States to adopt the system. DEXTER’s mobile, sterile console design enables efficient integration into outpatient facilities, enhancing surgical precision and workflow without disrupting existing procedures.
Received FDA clearance for ChestView, its advanced chest X-ray interpretation solution that uses computer-aided detection (CADe) technology to detect multiple pathologies and highlight abnormalities on images. This clearance follows Gleamer’s BoneView introduction and strengthens its AI-powered imaging portfolio, enhancing diagnostic accuracy and efficiency across U.S. healthcare providers.
Announced a partnership to enhance cardiac monitoring accessibility by combining Happitech’s smartphone-based monitoring with Wellysis’s S-Patch, a lightweight, reusable continuous ECG monitoring device developed through years of R&D. The collaboration aims to make cardiac care simpler and more scalable, benefiting both patients and physicians worldwide.
Expanded its partnership with Philips to enhance AI-enabled digital pathology workflows, integrating Ibex’s AI-powered cancer diagnostics with Philips IntelliSite Pathology Solution (PIPS). The collaboration aims to improve diagnostic accuracy and efficiency, supporting pathologists with streamlined workflows and enhancing patient care amid the global shortage of pathologists.
Appointed Kevin Kearney as Chief Commercial Officer to drive commercial growth and expand access to its AeroPace System for ventilator weaning. With 20+ years of experience in commercial leadership, Kearney will also support the company’s clinical expansion of the investigational AeroNova System, aimed at mitigating multi-organ ventilator-induced injury.
Appointed Yvonne Bokelman, MBA, FACHE, as its new Executive Director to lead its mission of empowering and elevating women in the medtech industry. With leadership experience at Zimmer Biomet, Medtronic, and Alyve Medical, Yvonne’s passion for mentorship and advocacy will drive MedtechWOMEN’s growth and impact across the industry.
Partnered with Dräger to integrate BiliPredics, NeoPredics’ predictive jaundice management tool, into Dräger’s neonatal care portfolio. This collaboration aims to enhance early detection and intervention for neonatal jaundice by providing clinicians with AI-powered tools that predict bilirubin progression up to 60 hours in advance, supporting more timely and informed decision-making.
Received CE Mark approval for AlphaDBS, its adaptive deep brain stimulation (aDBS) system designed to dynamically adjust stimulation based on real-time brain signals. The approval enables commercial launch in Europe, offering optimized symptom control, reduced side effects, and minimized frequency of programming adjustments by neurologists.
Announced that it will be acquired by INDO-MIM Ltd., a global leader in precision component manufacturing, and rebranded as PDV MedTech. The acquisition aims to enhance innovation, broaden services, and improve quality and efficiency for medical device manufacturing with expanded global reach and resources.
Received FDA Breakthrough Device Designation for its PMcardio STEMI AI ECG model, designed to detect ST-elevation myocardial infarction (STEMI) and STEMI equivalents. The designation accelerates its path to market approval, enhancing early, precise heart attack diagnosis and treatment.
Received FDA 510(k) clearance for its Ossera™ AFX Ankle Fusion System, a 3D-printed fusion solution featuring TIDAL Technology™ for optimized osseointegration and biomechanical stability. The system, set for commercial availability in May 2025, will be showcased at ACFAS 2025 alongside other personalized foot and ankle solutions.
Appointed Gary Kurdziel as Chief Executive Officer, effective April 1, 2025, succeeding Geoff Klass, who is retiring after six years of service. Kurdziel brings extensive global leadership experience in the medical device industry, including roles at Medtronic, and will guide the company through key phases of FDA and Department of Defense collaboration.
Celebrated the first close of its London-based medtech venture capital fund at £27M, anchored by the British Business Bank’s Enterprise Capital Funds Programme and led by an all-female General Partner team. Fund I will invest in UK startups developing digital healthcare solutions and medical devices, focusing on chronic conditions, oncology, cardiovascular, mental health, neurology, care service delivery, and women’s health.
Partnered with Northwestern Medicine to advance automation in phlebotomy through a multicenter clinical trial validating its Aletta™ Autonomous Robotic Phlebotomy Device™ (ARPD™). The collaboration aims to address workforce shortages, improve sample quality, and enhance efficiency and patient comfort in U.S. hospital and outpatient blood draw centers.
Raised $5M to advance its catheter-based device for treating acute respiratory distress syndrome (ARDS) by delivering oxygen directly into the bloodstream. Funding from Harbright Ventures, Duke Capital Partners, DARPA, and others will support device development and future clinical trials.
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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