In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni receive FDA 510(k) clearance, secure new funding, announce positive clinical trial results, and much more on the road to LSI USA ‘25 in Dana Point, CA (March 17-21).
Secured a $3.5 million Phase II Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH). The new funds will support the continued development of the company’s kidney preservation technology.
Received FDA 510(k) clearance for its first AI software. The software is designed to improve the accuracy of detecting morphological abnormalities that suggest the presence of congenital heart defects during fetal heart ultrasounds.
Successfully closed a convertible note funding round led by Kendall Capital Partners. The new funding will be used to accelerate the company's efforts to advance its pipeline of skeletal reconstruction solutions.
Submitted an IDE application for its pivotal colorectal clinical study. The IDE will allow the company to initiate its Prospective Assessment of a Robotic-Assisted Device in Gastrointestinal Medicine (PARADIGM) study for its Endoluminal Robotic Surgical System.
Announced that CMS granted it a permanent HCPCS code for OPPS. The new code—A9615 Injection, pegulicianine, 1 mg—will allow for streamlined billing and reimbursement for healthcare providers and patients. The company also announced the appointment of Howard Hechler as CEO.
Shared the positive impact of CMS’ final ruling on the Local Coverage Determination for skin substitute grafts/cellular and tissue-based products for treating diabetic foot ulcers and venous leg ulcers. With this ruling, vascular assessments like the MIMOSA Pro are included in the standard of care requirements.
Announced positive 12-month results from the Abbreviated Protocol for Two Stage Exchange (APEX) clinical trials of VT-X7 KIT in patients with periprosthetic joint infections of the hip or knee. The results were featured at the 2024 American Association of Hip and Knee Surgeons.
Announced three regulatory milestones. The company announced that its TMINI Miniature Robotic System has received FDA 510(k) clearance for use with the Freedom Total Knee, Freedom Titan Knee, and Freedom Primary PCK Systems; the MOBIO Total Knee System; and the LinkSymphoKnee.
Presented new data demonstrating the capabilities of its vMap technology, an AI-powered arrhythmia analysis tool. The vMap algorithm demonstrated 91.1% accuracy and a sensitivity of 97.1%, surpassing the 62.5% accuracy of traditional visual ECG analysis.
Received FDA Breakthrough Device Designation for its vascular access conduit, aXess. The company also announced that the first patient in aXess’ U.S. pivotal study has been enrolled and treated at the Flow Vascular Institute in Houston, Texas.
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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