$11 million in proceeds expected to be received during 2026, with remainder of expected proceeds to be received in future revenue earnoutsVivasure Medical Limited (“Vivasure”) has been a strategic holding of Orchestra BioMed since the Company’s formation NEW HOPE, Pa., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships ...

Core Insights - Medtronic has received FDA 510(k) clearance for its MiniMed Go™ Smart MDI system, which integrates insulin dosing and glucose data into a single app, aimed at improving diabetes management for individuals on multiple daily injections [1][2]. Product Overview - The MiniMed Go™ system combines the InPen™ smart insulin pen and Abbott's Instinct sensor, providing real-time glucose data, dose calculations, missed dose alerts, and actionable guidance [9]. - The system is designed for individuals aged 7 years and older with insulin-requiring type 1 and type 2 diabetes, and for children aged 2 to 6 under adult supervision [2]. Market Need - Over 15 million people globally rely on multiple daily injections for diabetes management, often facing challenges during mealtimes that can lead to diabetes distress [3]. - Missed boluses can significantly affect diabetes management, with just two missed doses a week potentially raising HbA1C levels by up to 0.4%, increasing the risk of complications [4]. Performance Data - Previous users of Medtronic's Smart MDI system experienced improvements in glycemic control, with Time in Range (TIR) increasing from 55.7% to 67.2% when responding to over 75% of missed dose alerts within an hour [5]. Company Vision - Medtronic aims to simplify diabetes management for individuals using injections by providing the benefits of automated insulin delivery systems, thereby reducing the burden of daily insulin dosing [6]. Features and Benefits - The MiniMed Go™ system includes missed dose alerts, a dose calculator for easier decision-making, action-oriented guidance for missed or miscalculated doses, and CareLink™ software for enhanced provider collaboration [7]. Launch Timeline - The commercial launch of the MiniMed Go™ system is expected to begin in the U.S. in the spring of 2026 [8]. Company Background - Medtronic is a leading global healthcare technology company focused on innovative solutions for various health conditions, including diabetes management, with a commitment to enhancing patient outcomes through advanced technology [12].

Core Insights - The CGuard Prime Carotid Stent System has demonstrated the lowest 30-day and 1-year major adverse event rates in pivotal studies of carotid stenting [1][2][3] Group 1: Clinical Trial Results - The C-GUARDIANS pivotal trial published in the Journal of the American College of Cardiology (JACC) shows a 30-day disabling stroke or myocardial infarction (DSMI) rate of 0.95% and a one-year ipsilateral stroke rate of 1.93%, the lowest reported for high-risk patients [2][3] - The trial included 316 patients across 24 sites in the U.S. and Europe, with 25% of participants being symptomatic, indicating a favorable comparison to other carotid revascularization methods [4][2] - The primary endpoint of the trial was met, with the upper bound of the two-sided 95% confidence interval for the observed primary endpoint rate being less than 11.6% [4] Group 2: Technology and Market Position - The MicroNet™ technology used in the CGuard Prime is positioned as a potential next-generation standard of care for carotid artery stenting, expanding patient eligibility without compromising outcomes [3][4] - The publication in JACC is expected to enhance physician awareness and engagement, driving adoption of the CGuard Prime technology [3][4] - InspireMD aims to establish its MicroNet™ mesh technology as the industry standard for carotid stenting, focusing on achieving outstanding acute results and durable, stroke-free long-term outcomes [5]

CHARLOTTE, N.C., Jan. 12, 2026 (GLOBE NEWSWIRE) -- DENTSPLY SIRONA Inc. (“Dentsply Sirona” or the "Company") (Nasdaq: XRAY), the world’s largest diversified manufacturer of professional dental products and technologies, today announced the appointment of Mark R. Bezjak as Group Vice President, Americas Regional Commercial Organization, effective January 28. The appointment supports Dentsply Sirona’s continued focus on strengthening commercial execution, deepening customer relationships and accelerating grow ...

Fiscal Year 2025 worldwide revenue of $200.8 to $200.9 million, representing growth of ~20%SANTA CLARA, Calif., Jan. 12, 2026 (GLOBE NEWSWIRE) -- SI-BONE, Inc. (Nasdaq: SIBN), the global leader in developing procedural solutions to address clinical challenges associated with compromised bone, today announced its preliminary and unaudited revenue and cash and cash equivalents for fourth quarter and full year 2025. Fourth Quarter 2025 Summary (any comparisons are to the prior year period) Worldwide revenue be ...

Core Insights - Outset Medical, Inc. reported unaudited revenue for Q4 and fiscal year 2025, highlighting a 5% increase in annual revenue to approximately $119.5 million compared to $113.7 million in 2024 [8] - The company has appointed Karen N. Prange to its board of directors, bringing extensive experience in commercial operations and strategy [4][5][6] - Outset Medical aims to leverage its innovative technology to enhance patient care outcomes while reducing costs and complexity in dialysis [3] Financial Performance - Q4 revenue reached approximately $28.9 million, contributing to the total revenue of approximately $119.5 million for 2025 [8] - The year-end cash position, including restricted cash and short-term investments, totaled $173 million, with net cash used in operations below $50 million in 2025, a significant decrease from $116 million in 2024 [8] Company Developments - Outset Medical has established a strong backlog and a growing pipeline of opportunities as it enters 2026 [3] - The company has enabled over 1,000 care sites to insource dialysis, performing roughly 1 million treatments annually, with a cumulative total of over 3 million treatments on its Tablo system [8] - The appointment of Karen Prange is expected to enhance the board's capabilities in navigating growth opportunities in the acute-care setting [6]

Core Viewpoint - Picard Medical, Inc. has entered into a development collaboration agreement with Hydrix Services Pty Ltd to advance the next-generation fully implantable Total Artificial Heart technology, known as the Emperor, which aims to enhance patient mobility and convenience by eliminating the need for an external driver [1][2]. Company Overview - Picard Medical, Inc. is the parent company of SynCardia Systems, LLC, which is recognized for developing the only commercially available total artificial heart technology for patients with end-stage heart failure [5]. - SynCardia's Total Artificial Heart (STAH) is the first artificial heart approved by both the U.S. FDA and Health Canada, with over 2,100 implants performed across 27 countries, making it the most widely used artificial heart globally [5]. Collaboration Details - The partnership with Hydrix was chosen due to its expertise in complex critical engineering and a strong track record in developing regulated medical devices, particularly mechanical circulatory support systems [2]. - The development work under this agreement will continue through the end of 2026 as part of a broader multi-stage program, with progress contingent on technical performance and safety validation [3]. Financial Incentives - The collaboration may allow Picard to benefit from Australian R&D tax incentives of approximately 43% of eligible expenditure, subject to qualification and review [3]. Hydrix Overview - Hydrix Limited is a product innovation company focused on enhancing health and well-being through its services in design, engineering, and delivery of medical products, as well as investing in high-potential MedTech clients [4].

Limited Market Release (LMR) of the LIBERTY® System is on Schedule Building on Positive Customer Feedback and Growing Market Enthusiasm, the Company Prepares for Full Market Release (FMR) in Q2 HINGHAM, Mass., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer and distributor of the innovative LIBERTY® Endovascular Robotic System, is continuing to generate significant market and new customer momentum as it enters 2026. In 2025, the Company met its milestones, including several ...

Core Viewpoint - Picard Medical, Inc. has entered into a development collaboration agreement with Hydrix Services Pty Ltd to advance the next-generation fully implantable Total Artificial Heart technology, known as the Emperor, which aims to enhance patient mobility and convenience by eliminating the need for an external driver [1][2]. Company Overview - Picard Medical, Inc. is the parent company of SynCardia Systems, LLC, which is recognized for developing the only commercially available total artificial heart technology for patients with end-stage heart failure. The SynCardia Total Artificial Heart (STAH) is the first artificial heart approved by both the U.S. FDA and Health Canada, with over 2,100 implants performed across 27 countries, making it the most widely used artificial heart globally [5]. Collaboration Details - The selection of Hydrix as a development partner is based on its expertise in complex critical engineering and a strong track record in developing regulated medical devices, including mechanical circulatory support systems. This collaboration aligns with Picard Medical's strategy to partner with leading engineering organizations for long-term development of life-sustaining technologies [2][3]. - Under the agreement, Hydrix will conduct development work for Picard and SynCardia through the end of 2026 as part of a multi-stage development program for the Emperor, which will progress through defined engineering verification and regulatory milestones [3]. Financial Incentives - The collaboration may allow Picard to benefit from Australian R&D tax incentives of approximately 43% of eligible expenditure, subject to qualification and review, which could enhance the financial viability of the development program [3]. Hydrix Overview - Hydrix Limited is a product innovation company focused on enhancing health, safety, and well-being through its services in design, engineering, and delivery of innovative medical products. The company operates across three segments: Services, Ventures, and Medical [4].

Core Viewpoint - A class action lawsuit has been filed against Integer Holdings Corporation and its senior executives for securities fraud following a significant drop in stock price due to alleged violations of federal securities laws [1][3]. Company Overview - Integer Holdings Corporation specializes in designing and manufacturing cardiac rhythm management and cardiovascular products, including electrophysiology devices that diagnose and treat arrhythmias [4]. Allegations of Securities Fraud - The lawsuit claims that Integer misrepresented the demand and revenue for its electrophysiology products, which had reportedly fallen sharply, contradicting the company's public statements about sales growth and market position [4][5]. Stock Price Decline - On October 23, 2025, Integer revised its 2025 sales guidance down to between $1.840 billion and $1.854 billion, significantly below analysts' expectations, leading to a stock price drop of $35.22 per share, or over 32%, from $109.11 to $73.89 [6]. - The company also projected poor net sales growth of -2% to 2% and organic sales growth of 0% to 4% for 2026, citing slower adoption of two of its EP devices [6].