In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni enter new partnerships, secure new funds, achieve regulatory milestones, and much more on the road to LSI Asia ‘25 in Singapore (June 10-13).
Raised $3M in equity financing to expand manufacturing capacity, pursue ISO 13485 certification, and support commercial growth of its advanced biopolymer fiber platform. The investment enables 3DBioFibR to meet growing demand across medical, defense, and consumer sectors with high-performance, clinically relevant biomaterials.
Announced a year-long partnership with the British Heart Foundation to support cardiovascular research through cause-related donations tied to KardiaMobileⓇ 6L sales in the UK. The campaign unites AliveCor’s AI-powered ECG technology with the charity’s legacy in scientific research to advance early detection and treatment of heart conditions.
Received FDA Breakthrough Device Designation for its Total Artificial Heart (TAH) system, designed as a bridge-to-transplant solution for patients with severe biventricular or univentricular heart failure. The designation accelerates BiVACOR’s clinical development of its compact, magnetically levitated heart replacement technology.
Received FDA De Novo authorization for CLAIRITY BREAST, the first AI platform authorized to predict five-year breast cancer risk from a screening mammogram alone. The milestone positions Clairity’s image-based solution to transform early detection and personalized prevention strategies for women’s health.
Announced a new know-how agreement with Mayo Clinic to refine Corify Care’s AI-powered cardiac mapping system for arrhythmia treatment. The partnership aims to enhance clinical workflow and procedural guidance, accelerating adoption of Corify’s noninvasive, real-time global mapping technology for complex heart rhythm disorders.
Secured €2.3M in oversubscribed seed funding led by Kadmos Capital to launch SPINEsim, MDsim’s first Software as a Medical Device for personalized spine surgery planning and back pain prevention. The funding will accelerate development of patient-specific digital twin technologies aimed at improving outcomes and reshaping the future of spine care.
Closed its oversubscribed Pre-Series A $7.5M funding round to advance CLiKX, NousQ’s device designed to shift pediatric ear tube surgery from the OR under general anesthesia to a clinic-based, anesthesia-free procedure. The raise supports broader clinical adoption of CLiKX and accelerates NousQ’s mission to make hearing restoration safer, simpler, and more accessible worldwide.
Completed its first-in-human implant of the Connexus Brain-Computer Interface during epilepsy surgery at the University of Michigan, demonstrating Paradromics’ system can be safely implanted and record neural activity. The milestone transitions the neurotech company into its clinical stage, paving the way for a planned trial evaluating long-term safety and performance in patients with severe motor impairments.
Announced the completion of its prospectus offering to support commercialization of Perimeter’s ultra-high-resolution imaging technologies for cancer surgery. The company intends to use the proceeds to continue commercialization of its technology, gather clinical evidence, and continue product development.
Received MHRA approval to initiate a 15-patient cranial flap fixation pilot trial in the UK using TETRANITEⓇ, RevBio’s regenerative bone adhesive. The study expands global clinical validation and explores standalone and adjunctive use to improve cosmetic outcomes and reduce cerebrospinal fluid leak risks following brain surgery.
Received a $1.8M AFWERX grant from the U.S. Air Force to support its upcoming post-market clinical studies of Spiro Robotics’ airway management system. The award also qualifies the company for up to $2M in TACFI matching funds, advancing its FDA clearance strategy and global expansion plans.
Received a $750K non-dilutive grant from the Rhode Island Life Science Hub to support VeinTech’s U.S. expansion and FDA strategy for its real-time IV insertion technology. The award accelerates the company’s commercial launch, U.S.-based manufacturing, and limited market release.
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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