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Surgery
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ZAP Surgical anuncia los primeros tratamientos con la plataforma ZAP-X Gyroscopic Radiosurgery en Latinoamérica

SAN CARLOS, California--(BUSINESS WIRE)--ZAP Surgical Systems, Inc. líder mundial en cirugía cerebral robótica no invasiva, anunció hoy los primeros tratamientos de pacientes utilizando su plataforma ZAP-X® Gyroscopic Radiosurgery® en Latinoamérica. Ubicada en Neuland, Boquerón, Paraguay, Radioterapia Concordia (www.saludconcordia.com) ha comenzado oficialmente su uso clínico, marcando un hito importante en la descentralización de la atención vanguardista para tumores cerebrales en toda la regi...
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ZAP Surgical Announces First ZAP-X Gyroscopic Radiosurgery Patient Treatments in Latin America

SAN CARLOS, Calif.--(BUSINESS WIRE)--ZAP Surgical Systems, Inc., a global leader in non-invasive robotic brain surgery, today announced the first patient treatments using its ZAP-X® Gyroscopic Radiosurgery® platform in Latin America. Located in Neuland, Boquerón, Paraguay, Radioterapia Concordia (www.saludconcordia.com) has officially commenced clinical use, marking a major milestone in the decentralization of state-of-the-art brain tumor care across the region. In its first day of operation, f...
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Newly Published Health Economics Study Demonstrates In-Office Ear Tube Procedures with Hummingbird TTS Significantly Reduce Healthcare Costs

GOLDEN VALLEY, Minn.--(BUSINESS WIRE)--Preceptis Medical, Inc., a pioneer in pediatric ENT innovation, today announced the publication of a health economic study assessing the financial impact of shifting pediatric tympanostomy tube (ear tube) placement from operating room to in-office settings. The analysis, published in the Journal of Medical Economics, demonstrates significant cost savings potential for Commercial and Medicaid health insurance payers that provide access to in-office ear tube...
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AventaMed, a KARL STORZ Company, Receives Expanded Indication for Solo+ Tympanostomy Tube Device (TTD)

EL SEGUNDO, Calif.--(BUSINESS WIRE)--KARL STORZ United States is proud to announce that the US Food and Drug Administration (FDA) has cleared an expanded indication for the AventaMed Solo+™ Tympanostomy Tube Device (TTD), allowing its use in pediatric patients aged 6 months and older. This expanded clearance builds on the previous 510(k) clearance, which was indicated for patients 6 to 24 months old. The Solo+ device represents a significant advancement in pediatric ENT care. It is intended to...
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FDA’s Approval of Keytruda for PD-L1 Positive Head and Neck Cancer Patients Signals a Clear Pathway for CEL-SCI’s Multikine to Address a Major Unmet Need in PD-L1 Negative Cancer Patients

VIENNA, Va.--(BUSINESS WIRE)--FDA’s Approval of Keytruda for PD-L1 Positive Head and Neck Cancer Patients Signals a Clear Pathway for CEL-SCI’s Multikine....
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ReGelTec Announces First Patient Treated in U.S. IDE Clinical Trial for HYDRAFIL System to Treat Chronic Low Back Pain

BALTIMORE--(BUSINESS WIRE)--ReGelTec Inc., a company developing a percutaneous hydrogel implant for the treatment of chronic low back pain caused by degenerative disc disease, announced it has treated the first patient in its HYDRAFIL-D FDA investigational device exemption (IDE) clinical trial for its HYDRAFIL® System for disc augmentation. The patient was enrolled by Kas Amirdelfan, M.D., an interventional pain physician and founding member of Boomerang Healthcare, Inc. in Walnut Creek, Calif....
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ANACONDA Biomed Receives CE Mark for Its ANA5 Funnel Catheter to Treat Ischemic Stroke

BARCELONA, Spain--(BUSINESS WIRE)--ANACONDA Biomed, a medical technology company developing next-generation thrombectomy systems for the treatment of ischemic stroke, has announced that it has received CE Mark certification for its ANA5 Funnel Catheter. The CE marking confirms that the ANA5 device complies with the European Union's health, safety, and environmental protection standards, enabling its eventual commercial viability across the EU. The ANA5 Funnel Catheter is engineered to optimize...
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Harrow Appoints Mike Biega as Vice President of Investor Relations and Communications

NASHVILLE, Tenn.--(BUSINESS WIRE)--Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, today announced that Mike Biega has joined Harrow as Vice President of Investor Relations and Communications, succeeding Jamie Webb, Director of Communications and Investor Relations, who recently announced her retirement. Jamie will remain in her role into August to support a smooth and effective transition. “We are excited to welcome Mike to the Harrow Family. His wealth of exper...
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Virtual Incision Appoints Jim Alecxih as Chief Executive Officer

LINCOLN, Neb.--(BUSINESS WIRE)--Virtual Incision Corporation, the developer of the MIRA Surgical System authorized by the FDA through the De Novo regulatory pathway, today announced the appointment of Jim Alecxih as chief executive officer. Alecxih, a recognized commercial leader in the medical device industry, brings more than 30 years of experience advancing transformative surgical technologies worldwide, including a distinguished tenure at Intuitive Surgical, where he played a pivotal role i...
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ChoiceSpine™ Announces Launch of ChoiceSpine™ App for Surgical Use with eCential Robotics Op.n™ Robotic and Navigation Platform

KNOXVILLE, Tenn. & FRANKLIN, Tenn.--(BUSINESS WIRE)--ChoiceSpine™ Announces Launch of ChoiceSpine™ App for Surgical Use with eCential Robotics Op.n™ Robotic and Navigation Platform....