Polarean’s FDA cleared coil achieves important milestone, expanding clinical reach XENOVIEW® 3T coil passes Philips compatibility testing XENOVIEW® 3T Chest Coil is now confirmed for integration with Philips MRI systems starting in 2026 DURHAM, NC and LONDON, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Polarean Imaging plc (AIM: POLX), a commercial-stage medical device leader in advanced Magnetic Resonance Imaging ("MRI") of the lungs, announces that its FDA-cleared XENOVIEW® 3T Chest Coil has successfully complet ...

Accessibility StatementSkip Navigation NEW YORK, Dec. 1, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Firefly Aerospace Inc. (NASDAQ: FLY). Shareholders who purchased shares of FLY 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/firefly-aerospace-inc-loss-submission-form/? ...

Core Insights - SciSparc Ltd. has signed a binding term sheet to acquire patents, trademarks, and intellectual property rights for innovative endoscopic systems, including the MUSE™ system, from Xylo Technologies Ltd. [1][4] Company Overview - SciSparc operates through its majority-owned subsidiary NeuroThera Labs Inc., focusing on clinical-stage pharmaceutical developments, particularly in cannabinoid pharmaceuticals [7]. Product Details - The MUSE™ system is a single-use endoscopic device designed for transoral fundoplication, a minimally invasive procedure for treating gastroesophageal reflux disease (GERD) [2]. Market Strategy - Following Xylo's successful commercialization in Greater China, SciSparc aims to replicate this model in high-growth regions like North America, Europe, and Latin America by forming exclusive partnerships with regional distributors [3]. Financial Terms of Acquisition - The acquisition will involve SciSparc issuing shares to Xylo, representing 19.99% of the company's issued and outstanding share capital upon closing of definitive agreements [4]. Market Potential - The global GERD device market was valued at approximately $2.5 billion in 2024 and is projected to grow to $3.03 billion by 2030, with a compound annual growth rate (CAGR) of 3.24% from 2025 to 2030 [5].

Core Insights - SINTX Technologies has signed a supply agreement with Evonik Corporation to manufacture a proprietary silicon nitride–PEEK compound for AI-assisted additive manufacturing of patient-specific implants [1][2][3] - The collaboration aims to leverage Evonik's industrial-scale manufacturing capabilities to produce SiN/PEEK, enabling SINTX to meet immediate physician requests for humanitarian-use vertebral body replacement implants [2][5] - The SiN/PEEK compound is expected to offer advantages over standard PEEK, including antipathogenic surface characteristics, osteogenic potential, and improved visualization for complex surgical procedures [3][4][7] Company Overview - SINTX Technologies specializes in advanced ceramics and biomaterials, focusing on silicon nitride for medical applications, with a strong patent portfolio and U.S.-based manufacturing [9] - The company has a history of thousands of medical devices implanted since 2008 and aims to expand its technology platform through innovation and market diversification [9] Industry Context - The partnership with Evonik is positioned as a significant advancement in the field of patient-specific implants, combining expertise in high-performance polymers with advanced biomaterials [3][4] - The SiN/PEEK compound is designed to support regulatory clearances for both patient-matched and traditionally manufactured implantable devices, indicating a strategic move towards broader market opportunities [2][5]

Core Insights - Catheter Precision, Inc. has successfully launched its LockeT suture retention device in Switzerland, marking a significant milestone for the company in the cardiac electrophysiology market [1][2] Company Overview - Catheter Precision is a U.S.-based medical device company focused on developing innovative solutions for the treatment of cardiac arrhythmias, particularly through advancements in electrophysiology procedures [4] Product Launch and Clinical Outcomes - The first clinical cases of the LockeT device were performed at Spitalzentrum Biel, led by PD Dr. Rainer Zbinden, resulting in excellent procedural outcomes and positive feedback from clinical and nursing teams [2] - The LockeT device is designed to assist in wound closure after percutaneous venous punctures and is classified as a Class 1 device registered with the FDA, also having received CE Mark approval [3] Strategic Partnerships - The launch follows a strategic distribution agreement with FuMedica AG, a prominent Swiss medical device distributor, which will facilitate the introduction of LockeT to hospitals and clinics across Switzerland, thereby expanding Catheter Precision's European presence [2][3] Market Growth - Over 10,000 LockeT devices have been shipped globally, indicating rapid growth and the company's commitment to working closely with partners to enhance patient care [3]

Philips LumiGuide 3D device guidance in use Philips LumiGuide 3D device guidance in use December 1, 2025 Commercial availability expanded across Europe and the United StatesReal-time AI-enabled 3D device visualization powered by light instead of X-ray, improving navigation in complex endovascular proceduresLumiGuide seamlessly integrates with Azurion, Philips’ proven, world-leading image-guided therapy platform designed to drive procedural innovation across clinical domains Amsterdam, the Netherlands an ...

Core Viewpoint - Royal Philips has announced the expanded commercial availability of LumiGuide 3D Device Guidance, the first real-time AI-enabled light-based 3D navigation solution for image-guided therapy, across Europe and the United States, marking a significant advancement in radiation-free navigation technology [2][10]. Group 1: Product Overview - LumiGuide allows physicians to visualize and guide devices inside the body using light instead of continuous X-ray, enhancing radiation safety and dose reduction in image-guided therapy [2][5]. - The technology integrates seamlessly with Philips' Azurion platform, which is designed to drive procedural innovation across various clinical domains [3][9]. - LumiGuide utilizes Fiber Optic RealShape (FORS) technology to provide high-resolution, full-color images in real-time, enabling precise navigation during complex endovascular procedures [5][8]. Group 2: Clinical Impact - Clinical experiences indicate that LumiGuide can improve efficiency, reduce procedure time, and minimize fluoroscopy pedal usage, with complex aortic repair procedures performed 37% faster and with up to 56% reduction in dose area product (DAP) [4][5]. - Over 2,000 clinical procedures have utilized LumiGuide, demonstrating its effectiveness and integration with the Azurion platform [10]. Group 3: Market Expansion - Following a successful limited market release in late 2023, LumiGuide will be commercially available from January 2026 in key European markets and the United States, expanding access to advanced image-guided therapy [10][14]. - Philips aims to enhance the adoption of this technology in hospitals to improve treatment precision and safety while reducing radiation risks for both patients and clinical staff [6][7]. Group 4: Commitment to Safety - LumiGuide is part of Philips' broader portfolio aimed at reducing or eliminating radiation exposure during image-guided procedures, reinforcing the company's leadership in low- and no-dose interventional solutions [11][14]. - The integration of LumiGuide with other technologies like Azurion with ClarityIQ and DoseAware further emphasizes Philips' commitment to advancing radiation safety in medical procedures [11].

KIRKLAND, Wash., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), a wearable medical device and digital healthcare company, today announced an underwritten public offering of 5,500,000 common shares. Kestra is offering these shares pursuant to a registration statement on Form S-1 filed with the Securities and Exchange Commission (“SEC”). Kestra also intends to grant the underwriters a 30-day option to purchase up to an additional 825,000 common shares at the public offerin ...

Core Insights - Long Cast Advisers reported a cumulative net return improvement of 4% in Q3 2025, with a total cumulative return of 266% net of fees since inception in November 2015, translating to a 14% CAGR [1] Company Summary - Pro-Dex, Inc. (NASDAQ:PDEX) is highlighted as a key stock in Long Cast Advisers' Q3 2025 investor letter, specializing in powered surgical instruments for medical device OEMs [2] - The stock of Pro-Dex, Inc. experienced a one-month return of 1.50% but has seen a significant decline of 25.65% over the past 52 weeks, closing at $36.44 per share with a market capitalization of $119.523 million as of November 28, 2025 [2] - Pro-Dex, Inc. issued a press release in mid-September addressing a significant stock decline, clarifying that it is not associated with a blockchain platform sharing the same ticker, and added a risk disclosure regarding potential AI-related errors affecting the stock [3]

NEW YORK, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces that a class action lawsuit has been filed against Inspire Medical Systems, Inc. (NYSE: INSP) and certain of the Company’s senior executives for securities fraud after a significant stock drop resulting from the potential violations of the federal securities laws. If you invested in Inspire, you are encouraged to obtain additional information by visiting: https://www.bfalaw.com/cases/inspire-medical- ...