Latest news with #KARLSTORZ
Yahoo
11 hours ago
- Health
- Yahoo
AventaMed, a KARL STORZ Company, Receives Expanded Indication for Solo+ Tympanostomy Tube Device (TTD)
Clearance Makes Office-Based Procedure Available to a Wider Range of Patients EL SEGUNDO, Calif., June 18, 2025--(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 deliver a tympanostomy tube (also known as a ventilation tube) into a patient's tympanic membrane, or eardrum, to treat problems arising from ear infections. Traditionally, this procedure would be performed in an operating room under general anesthesia. The Solo+ device offers a convenient alternative. Using as little as a topical anesthetic, the Solo+ device integrates multiple functions into a single, user-friendly instrument, deploying the tube with the press of a button. As a result, it enables tympanostomies to be performed in an office setting. New clinical findings support the safe and effective use of the Solo+ device, showing that physicians were consistently able to complete the procedure in the office as intended—without needing to move to the operating room. The Solo+ Tympanostomy Tube Device demonstrated consistent, reliable performance across pediatric age groups, with strong follow-up outcomes. These results provide both guardians and physicians with greater confidence in selecting an office-based approach to ear tube placement for a wider range of children. "On behalf of patients and their families, we are excited by this expanded indication," said Chris Smith, VP of Sales & Marketing, Head & Neck Division, at KARL STORZ US. "This makes it possible to offer this effective treatment to a broad population. With clear advantages like avoiding general anesthesia, reducing total procedural costs, and delivering high patient satisfaction, the Solo+ device will benefit doctors and patients alike. It's part of our commitment to provide technology that addresses real-world needs." About Ear Infections Chronic ear infections are a leading reason for doctor visits among young children.1-3 Children are more susceptible to this potentially painful condition, which can adversely affect the ability to hear.1 Treatment often involves procedures known as myringotomy and tympanostomy. Myringotomy involves making an incision in the eardrum to drain excess fluid from the middle ear. It is sometimes performed as a standalone treatment, but is often combined with tympanostomy, in which a tiny tube is inserted in the eardrum to alleviate pressure and allow fluid to drain. The procedure is common: by the age of three, nearly 1 in every 15 children will have had ear tubes.3 About KARL STORZ Since its founding in Germany in 1945, KARL STORZ has grown to become a leading global supplier of endoscopy solutions, including imaging and integration across all sites of care. Now in its third generation, the family-owned company employs 9,400 people in more than 40 countries worldwide. The company acquired the Solo+ technology through the acquisition of AventaMed, which was spun off from Munster Technological University in 2015. For more information, visit 1 Ahmed S et al. Incremental health care utilization and costs for acute otitis media in children. Laryngoscope. 2014;124(1):301-5. doi: 10.1002/lary.24190.2 Bhattacharyya N, Shay SG. Epidemiology of Pediatric Tympanostomy Tube Placement in the United States. Otolaryngol Head Neck Surg. 2020;163(3):600-602. doi: 10.1177/0194599820917397.3 Rosenfeld RM et al. Clinical Practice Guideline: Tympanostomy Tubes in Children. Otolaryngol Head Neck Surg. 2013;149:S1-S35. doi: 10.1177/0194599813487302. View source version on Contacts Susan ManciaMobile: 562-841-1515E-mail:
Business Wire
11 hours ago
- Health
- Business Wire
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+™ Tympanostomy Tube Device (TTD) has received expanded clearance from the FDA. The Solo+ device represents a significant advancement in pediatric ENT care. It is intended to deliver a tympanostomy tube (also known as a ventilation tube) into a patient's tympanic membrane, or eardrum, to treat problems arising from ear infections. Traditionally, this procedure would be performed in an operating room under general anesthesia. The Solo+ device offers a convenient alternative. Using as little as a topical anesthetic, the Solo+ device integrates multiple functions into a single, user-friendly instrument, deploying the tube with the press of a button. As a result, it enables tympanostomies to be performed in an office setting. New clinical findings support the safe and effective use of the Solo+ device, showing that physicians were consistently able to complete the procedure in the office as intended—without needing to move to the operating room. The Solo+ Tympanostomy Tube Device demonstrated consistent, reliable performance across pediatric age groups, with strong follow-up outcomes. These results provide both guardians and physicians with greater confidence in selecting an office-based approach to ear tube placement for a wider range of children. 'On behalf of patients and their families, we are excited by this expanded indication,' said Chris Smith, VP of Sales & Marketing, Head & Neck Division, at KARL STORZ US. 'This makes it possible to offer this effective treatment to a broad population. With clear advantages like avoiding general anesthesia, reducing total procedural costs, and delivering high patient satisfaction, the Solo+ device will benefit doctors and patients alike. It's part of our commitment to provide technology that addresses real-world needs.' About Ear Infections Chronic ear infections are a leading reason for doctor visits among young children. 1-3 Children are more susceptible to this potentially painful condition, which can adversely affect the ability to hear. 1 Treatment often involves procedures known as myringotomy and tympanostomy. Myringotomy involves making an incision in the eardrum to drain excess fluid from the middle ear. It is sometimes performed as a standalone treatment, but is often combined with tympanostomy, in which a tiny tube is inserted in the eardrum to alleviate pressure and allow fluid to drain. The procedure is common: by the age of three, nearly 1 in every 15 children will have had ear tubes. 3 About KARL STORZ Since its founding in Germany in 1945, KARL STORZ has grown to become a leading global supplier of endoscopy solutions, including imaging and integration across all sites of care. Now in its third generation, the family-owned company employs 9,400 people in more than 40 countries worldwide. The company acquired the Solo+ technology through the acquisition of AventaMed, which was spun off from Munster Technological University in 2015. For more information, visit 1 Ahmed S et al. Incremental health care utilization and costs for acute otitis media in children. Laryngoscope. 2014;124(1):301-5. doi: 10.1002/lary.24190. 2 Bhattacharyya N, Shay SG. Epidemiology of Pediatric Tympanostomy Tube Placement in the United States. Otolaryngol Head Neck Surg. 2020;163(3):600-602. doi: 10.1177/0194599820917397. 3 Rosenfeld RM et al. Clinical Practice Guideline: Tympanostomy Tubes in Children. Otolaryngol Head Neck Surg. 2013;149:S1-S35. doi: 10.1177/0194599813487302.
Yahoo
03-04-2025
- Health
- Yahoo
KARL STORZ Introduces the Slimline C-MAC S Single-Use Video Laryngoscope
New device offers a narrow profile designed to improve visibility and access during intubations EL SEGUNDO, Calif., April 03, 2025--(BUSINESS WIRE)--KARL STORZ announces the worldwide launch of the Slimline C-MAC® S single-use video laryngoscope for airway management. Built to the same high-quality standards as all KARL STORZ products, the Slimline C-MAC S blade delivers clear visibility for a confident intubation, even in the most challenging cases. Designed for optimal performance in airway management Medical professionals use a video laryngoscope to help insert a breathing tube into a patient's airway, a procedure known as intubation. This new device represents a user-focused evolution of the C-MAC S single-use blade, boasting a slimmer outer geometry. Healthcare providers treating patients in operating rooms, acute care settings, intensive care units, or pediatrics facilities will appreciate the Slimline C-MAC S video laryngoscope for its slender shape, which makes it comfortable to handle. Despite its slim profile, the Slimline C-MAC S device is incredibly durable, designed to handle tough situations without compromising performance. Slim, strong, and a more sustainable design The Slimline C-MAC S laryngoscope provides crystal-clear images, enhancing visibility and helping airway management teams see exactly where they need to place the breathing tube. Its slim profile is designed to enhance maneuverability even in challenging cases. By combining a reusable imager with a single-use blade, the Slimline C-MAC S scope reduces environmental impact by minimizing electronic waste.1 The innovative blade design cuts material use by 28 percent* while maintaining robust construction. New, eco-friendly peel-pouch packaging further reduces waste and simplifies storage. The blades are designed to connect seamlessly with the industry-leading C-MAC HD monitor and C-MAC Pocket Monitor from KARL STORZ, ensuring access to a comprehensive platform without needing to invest in additional equipment. Breakproof during intubation Slimline C-MAC S blades have been tested to withstand 4–6X the typical intubation force.2,3 The breakproof construction supports patient safety and product durability, even under high-pressure conditions.** With the trusted performance of German engineering and Swiss manufacturing, the new Slimline C-MAC S device delivers the quality of KARL STORZ's well-respected reusable blades in a convenient, single-use solution. "For 80 years, KARL STORZ has been creating high-quality medical instruments to empower our healthcare partners and improve patients' lives around the world. With the new Slimline CMAC S, we addressed our customers' need for convenience without compromising the quality they have come to trust from KARL STORZ. Our only option was to create a single-use video laryngoscope with the same quality and engineering as our reusable versions," said Jennifer de Oliveira, Senior Director, Sales & Marketing, Upper Endoscopy, at KARL STORZ United States. "Our dedication to quality in particular is why many physicians choose KARL STORZ intubation tools." The Slimline C-MAC S device is part of the comprehensive C-MAC product line, known for its connectivity and versatility, and is available in a range of blade sizes to suit different patient needs. *Compared to the previous model C-MAC S blade (MAC #4) **Breakproof for applied forces during intubation according to literature review 1Shen C-w, Tran PP, Minh Ly PT. Chemical Waste Management in the U.S. Semiconductor Industry. Sustainability. 2018;10(5):1545. 2KARL STORZ. KS06371/SSU Blades Initial Mechanical Safety Verification. 2024. Doc no. C2.1.3.0001.F005d-RSTR-KS06371. 3Russell T et al. Measurement of forces applied during Macintosh direct laryngoscopy compared with GlideScope® videolaryngoscopy. Anaesthesia 2012;67(6):626-631. Note: For more information on the availability of this product in individual markets, please contact a local KARL STORZ marketing and sales representative. About KARL STORZ KARL STORZ is an innovative leader in endoscopic technology and surgical imaging solutions across virtually all surgical specialties. Its integrated OR solutions, including advancements in digital surgery, enhance collaboration to improve clinical efficiency and outcomes inside the hospital and across other sites of care. With subsidiaries around the world, KARL STORZ is a family-owned company based in Germany that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship, and clinical effectiveness. For more information, visit View source version on Contacts Media contact:Susan ManciaMarketing CommunicationsKARL STORZ United States657-385-5285 Sign in to access your portfolio
Yahoo
18-03-2025
- Business
- Yahoo
Artisight Expands Collaborations with NVIDIA and KARL STORZ to Transform Operating Room Technology Through AI and Automation
Collaboration will develop AI-driven solutions for smart operating rooms with sophisticated monitoring and automation CHICAGO, March 18, 2025 /PRNewswire/ -- Artisight, Inc., provider of a Smart Hospital Platform powered by artificial intelligence (AI), is deepening its collaboration with KARL STORZ, a worldwide leader in Operating Room (OR) integration, and NVIDIA, to bring the next generation of AI-driven solutions to smart operating rooms. This collaboration builds upon the existing work between Artisight and KARL STORZ, now integrating NVIDIA's advanced AI computing platform to drive real-time surgical insights, automation, and enhanced perioperative efficiency. Through this collaboration, KARL STORZ is introducing a new solution for the OR, that leverages the NVIDIA Jetson™ platform to bring real-time surgical insights to clinicians and hospital administrators. NVIDIA Jetson delivers high performance AI compute and sensor processing capability for energy-efficient edge computing devices and autonomous machines. powered by NVIDIA Jetson, uses computer vision and ambient listening to automate OR and perioperative tasks, such as sending automated alerts to staff when surgery is complete or when an OR requires cleaning. "Artisight is able to bring these new technologies to ORs and hospitals across the globe with NVIDIA and KARL STORZ," said Andrew Gostine, MD, CEO and co-founder of Artisight. "Providers and patients are seeing improved outcomes and satisfaction scores that raise the standards of care across the perioperative continuum." Leveraging the NVIDIA AI computing platform, Artisight builds on its collaboration with NVIDIA by combining Artisight's expertise in deep learning and clinical operations to further optimize the functionality of KARL STORZ's OR1® integrated operating room technology, making them more intuitive and adaptable to various scenarios. "We are not just improving operating room efficiency—we are reimagining the entire surgical ecosystem and expanding access to services to eliminate disparities in care," added Gostine. "By leveraging the combined expertise of the three companies, we are harnessing the power of artificial intelligence to make an immediate impact on OR workflow," said Christy Gaudet, Vice President of Sales & Marketing, Surgical and OR1® at KARL STORZ US. "Our collaboration will enable healthcare providers to focus more on the most critical aspect of care: the patient." Powered by Artisight, is highly customizable and localized to each operative suite. Localized fine-tuning of each algorithm is essential because each institution serves a distinct combination of patients, procedures, and clinicians with unique workflows. Artisight's proprietary training process has been independently certified as HIPAA-compliant to protect both patient privacy and clinical autonomy. Artisight plans to continue increasing its pace of innovation by leveraging the latest technology from NVIDIA, including NVIDIA Riva for automatic speech recognition (ASR) and NVIDIA Cosmos Nemotron VLMs to query images and videos. "AI is transforming every industry, and we are only starting to see its profound impact in healthcare," said David Niewolny, director of business development for medtech at NVIDIA. "By collaborating with Artisight and KARL STORZ, we are shaping the future of healthcare and utilizing our combined capabilities to help medical professionals worldwide work more efficiently and enhance their ability to deliver exceptional care." About Artisight Artisight redefines the possibilities of healthcare through its Smart Hospital Platform and solutions for virtual care, quality improvement, and care coordination. Anchored in deep clinical knowledge and industry-defining artificial intelligence, Artisight's state-of-the-art computer vision and robust multi-sensor network adapts in real-time to specific environments and workflows, unlocking previously inaccessible data and ensuring seamless integration into your healthcare ecosystem. For more information, visit About KARL STORZ SE & Co. KG KARL STORZ is an innovative leader in endoscopic technology and surgical imaging solutions across virtually all surgical specialties. Its integrated OR solutions, including advancements in digital surgery, enhance collaboration to improve clinical efficiency and outcomes inside the hospital and across other sites of care. With subsidiaries around the world, KARL STORZ is a family-owned company based in Germany that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship, and clinical effectiveness. For more information, visit Media Contact Kim MohrAmendola Communications for Artisight949-322-3733kmohr@ View original content to download multimedia: SOURCE Artisight
