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As May draws to a close, the LSI alumni community is ending the month with another week of breaking medical device news stories. From receiving Breakthrough Device Designation and FDA clearance to pivotal trial results, these top medical device companies are paving the way to LSI Europe '24 in Portugal this September. Here’s a look at the latest updates from LSI alumni making waves in the medtech industry.
Atraverse Medical recently made headlines by raising a significant $12.5M Seed funding round and receiving FDA clearance for its HOTWIRE™ radiofrequency (RF) guidewire. The proprietary HOTWIRE™ system, featuring universal sheath compatibility and optimized RF technology, aims to enhance outcomes and streamline workflows for physicians treating cardiovascular disease in millions of patients worldwide.
Canary Medical achieved a major milestone by receiving FDA Breakthrough Device Designation for its Canturio® Lumbar Cartridge (canturio®lc) with Canary Health Implanted Reporting Processor (CHIRP®) System. The canturio®lc, used with a Lumbar Interbody System for spinal fusion from L1-S1, provides objective kinematic data during post-surgical treatment.
Ceretrieve announced the successful results of its multicenter, single-arm study, showcasing the capabilities of its state-of-the-art aspiration catheter. The company's vision is to be the doctor's first-choice device in treating ischemic stroke, offering complete treatment with superior performance in one device.
Colospan received FDA approval for a product line extension to its Intraluminal Bypass Device as part of the company’s investigational device exemption (IDE) application. The CG-100 is an investigational device for patients with colorectal cancer requiring an anastomosis and who are to receive a protective stoma under routine clinical practice.
Galvanize Therapeutics received FDA 510(k) clearance for its INUMI Flex endoscopic needle for use with the Aliya® PEF System. Aliya, with the INUMI Flex needle, is the first commercially available system to deliver PEF energy through an endoscope, enabling physicians to reach and non-thermally ablate soft tissue lesions.
Linshom Medical was awarded a $100K grant from the MIPS program to support a clinical study of its respiratory monitoring device. This study will evaluate the device’s ability for early detection of patient respiratory decline in the Post Anesthesia Care Unit, showcasing its potential impact on patient safety.
US Medical Innovations received FDA 510(k) clearance for the Canady Helios Cold Plasma™ Ablation System for the ablation of soft tissue during surgery. This system introduces a novel approach to soft tissue ablation using plasma, furthering advancements in new medical technology.
Vitestro shared its Pivotal Trial results confirming the performance, safety, and patient acceptance of its autonomous blood draw technology. Combining AI-based, ultrasound-guided imaging with robotic needle insertion, Vitestro’s device ensures accurate and secure blood collection.
Stay tuned for more updates as these medical technology companies continue to innovate and lead the way in the medtech industry. Whether it's securing new funding, achieving FDA milestones, or launching new products, the LSI alumni network is packed with medical device startups at the forefront of transforming healthcare. As we look forward to LSI Europe '24 in Portugal this September, the
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