Core Insights - Intuitive Surgical (ISRG) and Medtronic (MDT) are competing in the robotic-assisted surgery market, with ISRG's da Vinci system being the industry leader and MDT's Hugo platform emerging as a challenger [1][2] Market Performance - Year-to-date, ISRG shares have increased by 5.8%, while MDT shares have risen by 1.7%, compared to a 0.2% increase in the S&P 500 Index [5] Intuitive Surgical (ISRG) - ISRG holds a dominant position in robotic-assisted surgery with nearly 10,000 da Vinci systems installed globally, reflecting its technological advantage and integration in hospitals [6] - The company benefits from robust recurring revenues from instrument and accessory sales, which scale with increased surgical procedures [7] - ISRG is focusing on AI integration, real-time analytics, and next-generation robotics to enhance its platform, supported by recent FDA approvals in urology and gynecology [8] - The Zacks Consensus Estimate for ISRG's fiscal 2025 sales and EPS indicates a year-over-year improvement of 15.6% and 7.1%, respectively [9] Medtronic (MDT) - MDT has a diversified product portfolio and is focusing on its Hugo robotic-assisted surgery platform to compete with ISRG, although it faces regulatory hurdles and limited market penetration [11] - The company maintains solid revenue from legacy businesses and is implementing cost-saving initiatives to improve margins [12] - The Zacks Consensus Estimate for MDT's 2025 sales and EPS suggests a year-over-year improvement of 8.6% and 10.4%, respectively [14] Competitive Landscape - ISRG commands nearly 80% market share in robotic surgery, with sustainable revenue growth of 19% and a strong portfolio [16] - MDT's Hugo platform has shown early adoption potential but is still under limited commercial release, with full FDA approval expected next year [16] - The robotic-surgery market is projected to grow at a CAGR of 16.5% through 2029, favoring ISRG's continued growth [16]

Core Insights - Inspira Technologies is accelerating the commercialization of its INSPIRA ART100 system following successful clinical implementations in the U.S. [1][2] - The company is engaged in discussions with governmental health departments and private organizations to structure rollouts that align with clinical priorities [3] - Deliveries of the ART100 are expected to begin in the second half of 2025, contingent on logistical and regulatory alignment [3] Company Overview - Inspira Technologies specializes in advanced respiratory support and real-time blood monitoring solutions, with the ART100 system cleared by the U.S. FDA for cardiopulmonary bypass and ECMO procedures [5] - The company is also developing the next-generation INSPIRA ART500 and the HYLA blood sensor, aiming to support its innovation pipeline while focusing on near-term revenue from the ART100 [4] - Inspira is positioned as an attractive platform within the critical care and MedTech landscape, reflecting broader industry trends such as consolidation and cross-sector collaboration [5]

Core Insights - Iradimed Corporation has received FDA 510(k) clearance for its next-generation MRidium® 3870 IV Infusion Pump System, reinforcing its position as the only supplier of non-magnetic MRI infusion pump devices [1][3] - The MRidium® 3870 is designed to meet the increasing demand for safe fluid delivery in MRI environments, featuring advanced technology such as a non-magnetic ultrasonic pump motor and an intuitive touchscreen interface [2][3] Company Overview - Iradimed Corporation specializes in developing innovative MRI-compatible medical devices, including infusion pumps and patient monitoring systems [4][5] - The company is recognized as the only provider of a non-magnetic intravenous infusion pump system specifically designed for MRI procedures, addressing safety concerns associated with standard infusion pumps [5] Product Features - The MRidium® 3870 includes features such as non-interfering RF emissions, non-ferrous components, and the ability to operate as a four-channel IV infusion pump system, enhancing patient safety and workflow efficiency [2][3] - The system also incorporates a modern drug library solution, accommodating various patient care areas and drug listings, which broadens its application in MRI settings [2] Strategic Plans - The company plans to strategically roll out the MRidium® 3870 infusion pump, with initial deployments to select healthcare facilities in Q4 2025, followed by a ramp-up in material shipments throughout 2026 [3]

Core Viewpoint - Vivani Medical, Inc. plans to spin off its subsidiary Cortigent, Inc. into an independent publicly traded company on Nasdaq by the third quarter of 2025, aiming to enhance value for both Vivani and Cortigent stockholders [1][3][6] Company Developments - Cortigent is developing the Orion Visual Cortical Prosthesis System to provide visual perception for the blind and a Stroke Recovery System to aid recovery of arm and hand movement post-stroke [1][8] - The Orion system has received FDA Breakthrough Device designation and completed a six-year Early Feasibility Study with promising results [2][8] - Cortigent's previous product, the Argus II, was the first FDA-authorized artificial vision device, successfully implanted in hundreds of patients [2][8] Strategic Focus - The spin-off will allow Vivani to concentrate on its proprietary NanoPortal drug implant technology, specifically for chronic weight management and type 2 diabetes [1][2][3] - Vivani's lead program includes a six-month subdermal GLP-1 implant for chronic weight management, with additional products in development for type 2 diabetes [9][11] Financial and Operational Structure - The spin-off is expected to provide clearer visibility into the financial and operational structures of both companies, enhancing understanding of their respective strategies and risks [5][10] - The transaction is subject to various conditions, including board approval and SEC and Nasdaq compliance [6] Management and Leadership - Cortigent's CEO, Jonathan Adams, has extensive experience in the biopharmaceutical field and aims to accelerate the development of Cortigent's technologies post-spin-off [2][8]

NEW YORK, May 29, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Treace Medical Concepts, Inc. (NASDAQ: TMCI).Shareholders who purchased shares of TMCI during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.CONTACT US HERE:https://securitiesclasslaw.com/securities/treace-medical-concepts-inc-loss-submission-form-2/?id=150492&from=4CLASS PE ...

Core Viewpoint - NeuroPace, Inc. is under investigation for potential securities fraud and unlawful business practices following disappointing results from a clinical study [1][3]. Group 1: Company Performance - On May 27, 2025, NeuroPace announced the preliminary one-year results of the NAUTILUS study, which evaluated the safety and effectiveness of the RNS System for treating drug-resistant idiopathic generalized epilepsy (IGE) [3]. - The study did not achieve statistical significance for its primary effectiveness endpoint, which aimed to demonstrate a longer time to a second generalized tonic-clonic seizure in the active stimulation group compared to the sham stimulation group [3]. - Following the announcement, NeuroPace's stock price dropped by $5.02 per share, or 28.39%, closing at $12.66 per share on the same day [3]. Group 2: Legal Investigation - Pomerantz LLP is investigating claims on behalf of NeuroPace investors regarding possible securities fraud or other unlawful business practices by the company and its officers and/or directors [1]. - Investors are encouraged to contact Pomerantz LLP for more information about the investigation and potential class action [1].

Core Viewpoint - Pomerantz LLP is investigating claims on behalf of investors of Semler Scientific Inc. regarding potential securities fraud or unlawful business practices by the company and its officers or directors [1]. Group 1: Company Disclosure - On February 28, 2025, Semler filed its annual report for 2024, indicating a risk of a complaint from the U.S. Department of Justice (DOJ) related to a civil False Claims Act lawsuit [3]. - Semler disclosed receiving an initial civil investigative demand from the DOJ in July 2017 concerning reimbursement claims for its QuantaFlo device [3]. - The company participated in unsuccessful settlement discussions with the DOJ in February 2025 [3]. Group 2: Market Reaction - Following the news of the DOJ investigation, Semler's stock price dropped by $4.03 per share, or 9.4%, closing at $38.89 per share on March 3, 2025 [4].

Core Viewpoint - Artivion, Inc. has successfully closed transactions related to privately negotiated exchange agreements with holders of its 4.250% Convertible Senior Notes due 2025, significantly reducing its outstanding debt and enhancing its financial position [1][3]. Financial Transactions - The exchange agreements involved the conversion of approximately $99.54 million of Notes into 4,334,347 shares of common stock, along with a cash payment of approximately $1.7 million for accrued and unpaid interest [2]. - Following the transactions, only about $0.46 million in principal amount of the Notes remains outstanding [2]. Management Commentary - The CEO of Artivion highlighted that the retirement of the convertible notes is a significant milestone that reduces leverage ratios and enhances balance sheet flexibility [3]. Advisory Role - J. Wood Capital Advisors LLC served as the financial advisor to Artivion during these exchange transactions [4]. Company Overview - Artivion, Inc. is a medical device company focused on solutions for cardiac and vascular surgery, particularly in treating aortic diseases, with a product range that includes aortic stent grafts, surgical sealants, mechanical heart valves, and implantable tissues [7].

Company Overview - CVRx, Inc. is a commercial-stage medical device company focused on developing, manufacturing, and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases [3] - The company's flagship product, Barostim™, is the first FDA-approved medical technology that uses neuromodulation to alleviate symptoms in heart failure patients [3] - Barostim is an implantable device that delivers electrical pulses to baroreceptors in the carotid artery, aiming to restore balance to the autonomic nervous system and reduce heart failure symptoms [3] Recent Developments - CVRx management will present at the William Blair 45 Annual Growth Stock Conference on June 4, 2025, at 10:00 am Central Time via webcast [1] - A live audio webcast of the conference presentation will be accessible on the investor relations page of the company's website [2] Regulatory Approvals - Barostim has received FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. [3] - The device has also obtained the CE Mark for heart failure and resistant hypertension in the European Economic Area [3]

SANTA CLARA, Calif., May 28, 2025 (GLOBE NEWSWIRE) -- SI-BONE, Inc. (Nasdaq: SIBN), a medical device company dedicated to solving sacropelvic disorders, today announced that the company will be participating in the upcoming 2025 Goldman Sachs 46th Global Healthcare Conference in Miami Beach, FL. Management will be hosting a fireside chat on Tuesday, June 10, 2025, at 8:20 a.m. Pacific Time/11:20 a.m. Eastern Time. Investors interested in listening to the conference call may do so by registering at this link ...