In a successful week for the medical technology companies in the LSI Alumni community, we saw new patents, regulatory clearances, clinical trials, executive appointments, and much more. Read this week’s recap for a top-line look at the latest medical device news and achievements from the LSI Alumni on the road to LSI Europe '24 in Sintra, Portugal this September.
Bone Health Technologies announced it has been awarded a fifth patent for Osteoboost, the first and only FDA-cleared prescription medical device to treat osteopenia. This patent adds to their growing portfolio of innovations that support the treatment of bone health conditions. Additionally, the company announced the appointment of Michael Jaasma as Chief Scientific Officer and Vice President of Clinical and Regulatory Affairs, and Daniel Beeler as Vice President of Operations.
CeQur received FDA 510(k) clearance for its Simplicity system, which extends the wear time for the wearable mealtime insulin delivery patch from three to four days. This enhancement aims to provide greater convenience for people with diabetes, aligning with CeQur's mission to develop and commercialize simple drug delivery devices that can be easily integrated into daily life. The extended wear time of the Simplicity system represents a significant step forward in improving the quality of life for diabetes patients.
Galvanize Therapeutics announced the appointments of Doug Godshall to Executive Chairman and Zhen Su, MD, PhD to its Board of Directors. These appointments are set to strengthen the company’s leadership as it aims to become the global leader in delivering medical technology innovations that drive biologic processes to treat a range of diseases, including solid tumors and chronic bronchitis symptoms.
Genetesis formally launched the MICRO2 trial with the enrollment of its first patient. MICRO2 is a multicenter, prospective, observational study designed to validate magnetocardiography’s ability to detect myocardial ischemia caused by underlying coronary microvascular dysfunction. This trial marks a significant milestone in the development of non-invasive diagnostic tools that may improve the detection and management of heart disease.
InspireMD announced the completion of the full exercise of $12.9 million Series H warrants. The company seeks to utilize its proprietary MicroNet® technology to set new industry standards for carotid stenting by providing outstanding acute results and durable, stroke-free long-term outcomes. This financial milestone will support InspireMD’s ongoing efforts to enhance patient care in the treatment of vascular diseases.
MedtechWOMEN announced the appointment of Katie Arnold to its Advisory Board. Founded in 2010, MedtechWOMEN is a 501c3 organization dedicated to connecting, educating, and inspiring women in the medtech industry. By fostering an ongoing, content-driven, and solutions-oriented dialogue, the organization aims to shape the future of medtech.
Noah Medical published positive data from a clinical study demonstrating the success and safety of its Galaxy surgical robotic system. The Galaxy system is designed to improve location accuracy and diagnosis of lung nodules, representing a significant advancement in robotic-assisted surgery.
Paradromics has been accepted into the FDA’s Total Product Life Cycle Advisory Program (TAP) Accelerator Program. The company is developing a high data-rate brain-computer interface (BCI), with its first application being the Connexus® Direct Data Interface, a BCI-enabled assistive communication device for severely motor-impaired people. This acceptance into the TAP Accelerator Program is a crucial step towards bringing Paradromics’ technology to market.
Retia Medical announced positive results from a recent study evaluating the accuracy of its Argos multi-beat analysis against the PiCCO pulse-contour analysis during a passive leg raise and/or a fluid challenge. The Argos Cardiac Output Monitor aims to offer consistent accuracy using Multi-Beat Analysis, rapid setup, and an intuitive user interface while avoiding costly proprietary disposables. These findings underscore the effectiveness of Retia Medical’s innovative cardiac monitoring technology.
Valcare Medical announced the formation of a Scientific Advisory Board comprising renowned mitral valve experts, including Dr. Isaac George, Dr. Scott Lim, Dr. Paul Sorajja, Dr. Azeem Latib, and Dr. Federico DeMarco. Valcare’s mission is to transform mitral valve therapy through the development of advanced, minimally invasive solutions.
Vibrato Medical has completed enrollment in its clinical study evaluating the Therapeutic UltraSound in Chronic Limb-Threatening Ischemia. The company has developed the first wearable therapeutic ultrasound device for the noninvasive, outpatient treatment of peripheral arterial disease. This device is designed to promote vasodilation, collateral vessel growth, and angiogenesis, and restore perfusion, representing a promising new treatment for patients with peripheral arterial disease.
WISE announced the appointment of Stefano Magnetti as Director of Engineering. The company is developing a new generation of implantable leads for neuromonitoring and neuromodulation using its proprietary Supersonic Technology.
ZygoFix announced it is establishing operations in the United States. The company has developed a unique implant designed to achieve spinal fusion in the most minimally invasive approach and without using screws.
Stay tuned for more updates, insights, and achievements of our LSI Alumni in our Weekly Recap, and follow our blog for the latest medical device news and advancements.
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