In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni secure FDA clearance, appoint new executives, receive new grants, and much more as we wind down LSI Europe ‘24 in Sintra, Portugal, and gear up for LSI USA ‘25 in Dana Point, CA (March 17-21).
Secured FDA clearance for its IonPencil™. The product integrates Alesi’s proprietary surgical smoke management technology with a lightweight, silent, easy-to-use, and ergonomic electrosurgery device.
Began a trial to expand the label for its remote monitoring device. The CAVA study aims to validate the use of Alio’s SmartPatch technology for non-invasive monitoring of health metrics from the calf, including hemoglobin, hematocrit, potassium, SpO2, blood volume, and heart rate.
Appointed John Brumfield, a leader in cardiac rhythm management and heart failure, as CEO (effective October 1, 2024). The company is developing C-MIC, a novel implantable device that delivers a constant but minimal electrical DC to the heart.
Enrolled the 50th patient in its pivotal studies of the eShuntⓇ System for normal pressure hydrocephalus (NPH). The eShuntⓇ System consists of an endovascularly implantable CSF shunt and associated delivery componentry and is designed to avoid invasive surgery, general anesthesia, post-operative pain, and extended hospitalization.
Received a $2.4M NIH grant to conduct a first-in-human clinical trial for its regenerative bone adhesive for cranial flap fixation and enrolled the first five patients. The trial will evaluate the preliminary safety and probable benefit of TETRANITEⓇ for replacing metal plates and screws.
Received FDA 510(k) clearance for its Histolog™ Scanner. The scanner is a confocal microscopy device for imaging the surface of excised human tissue specimens, enabling the visualization of morphological microstructures.
Successfully implanted its Ormi device in a first-in-human trial. The study primarily aims to evaluate the safety of the Ormi device in patients with knee pain due to articular cartilage loss in the femoral condyle.
Secured a grant from the Defense Health Agency. The funds will be used to co-develop and manufacture an advanced SurgiBubble™, a single-use disposable sterile medical device designed to isolate the surgical site with a physical barrier from the environment.
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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