Patent covers estimation of measures of heart function using an ECG, which are critical in the diagnosis and early detection of heart diseaseSouthlake, TX, June 03, 2025 (GLOBE NEWSWIRE) -- HeartSciences Inc. (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (“AI”) powered medical technology company focused on transforming ECGs/EKGs to enable earlier detection of heart disease, today announced the grant by the United States Patent and Trademark Office (USPTO) of a foundati ...

Core Insights - ReShape Lifesciences has achieved certification for its Quality Management System (QMS) and medical devices under the EU Medical Device Regulation (MDR) and UK Conformity Assessment (UKCA), ahead of the December 31, 2027 deadline [1][3] - The EU MDR, effective since May 2021, imposes stricter requirements for clinical evaluation, post-market surveillance, and device traceability to enhance patient safety and product quality across the European Economic Area [2] - The certification positions ReShape Lifesciences among a select group of manufacturers compliant with the EU's rigorous standards, enabling the company to expand its product pipeline and maintain market access in Europe [3] Company Overview - ReShape Lifesciences specializes in weight loss and metabolic health solutions, offering a range of products including the FDA-approved Lap-Band System and investigational Diabetes Bloc-Stim Neuromodulation™ (DBSN™) system [4] - The company’s offerings include non-surgical options like the Obalon balloon technology, designed for long-lasting weight loss [4]

Core Insights - Veris Health Inc. has established a strategic partnership with The Ohio State University Comprehensive Cancer Center (OSUCCC – James) following a successful pilot program of the Veris Cancer Care Platform™ [1][4] - The partnership aims to enhance personalized cancer care through remote patient monitoring and the development of the Veris Cancer Care Platform [2][3] Group 1: Partnership Details - The agreement includes a long-term, multi-project collaboration to further develop and commercialize the Veris Cancer Care Platform and its implantable physiologic monitor [2][3] - Key components of the partnership involve expanding commercial utilization across cancer care service lines, full electronic health record (EHR) integration, and launching a large clinical registry and clinical trial [3][4] Group 2: Platform Features - The Veris Cancer Care Platform offers remote physiological data collection, symptom reporting, telehealth capabilities, and EHR integration, aiming to improve personalized cancer care [4][5] - Patients enrolled in the platform receive a VerisBox™ with connected health care devices that transmit data to a cloud-based clinician portal, along with a patient smartphone app for symptom reporting and health tracking [5] Group 3: Company Background - PAVmed Inc. is a diversified commercial-stage medical technology company operating in medical devices, diagnostics, and digital health sectors, with Veris Health as its majority-owned subsidiary [7] - Veris Health focuses on enhancing personalized cancer care through innovative technologies, including the development of an implantable physiological monitor [7]

Core Insights - NeuroOne Medical Technologies Corporation has appointed Emily Johns as General Counsel and Corporate Secretary, enhancing its management team [1][2] - The appointment is expected to reduce overall legal costs and support the company's strategic growth initiatives [2] Management Team Enhancement - Emily Johns brings nearly a decade of experience working with NeuroOne and has a strong background in legal matters related to biotechnology companies [2] - Her previous role as a partner at Honigman LLP involved representing NeuroOne in transactional work since 2017 [2] - The company believes her legal expertise will be invaluable as it scales its operations [2] Stock Options and Compensation - In connection with her appointment, Ms. Johns received an option to purchase 500,000 shares of the company's common stock at an exercise price of $0.611 per share [3] - The new senior director of quality assurance and regulatory affairs was also granted an option to purchase 75,000 shares under similar terms [3] Company Overview - NeuroOne is focused on developing minimally invasive and high-definition solutions for neurological disorders, including epilepsy and Parkinson's disease [4] - The company aims to improve patient outcomes and reduce procedural costs while exploring applications in other areas such as depression and chronic pain [4]

Libby brings strong team building, growth, and sales operations and systems skills to Sanuwave after a career of growing startups into mid- and large-sized companies.EDEN PRAIRIE, Minn., June 03, 2025 (GLOBE NEWSWIRE) -- Sanuwave Health, Inc. (the "Company" or "Sanuwave”) (NASDAQ:SNWV), a leading provider of next-generation FDA-approved wound care products, is pleased to announce the hiring of Dustin Libby as its EVP of commercial operations. Libby brings 20 years of medical device experience focused on com ...

Core Viewpoint - Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Semler Scientific, Inc. due to allegations of materially misleading business information issued by the company [1]. Group 1: Investigation and Legal Action - Shareholders who purchased Semler Scientific securities may be entitled to compensation through a class action lawsuit without any out-of-pocket fees [2]. - The Rosen Law Firm is preparing a class action to seek recovery of investor losses [2]. Group 2: Company Disclosure and Market Reaction - Semler Scientific filed its 2024 annual report on Form 10-K with the SEC, revealing that it had begun initial settlement discussions with the DOJ but ceased those discussions on February 11, 2025 [3]. - Following this disclosure, Semler Scientific's stock fell over 9% on the next trading day [3]. Group 3: Rosen Law Firm's Credentials - The Rosen Law Firm has a strong track record in securities class actions, having achieved the largest securities class action settlement against a Chinese company at the time [4]. - The firm has been ranked in the top 4 for securities class action settlements since 2013 and recovered hundreds of millions of dollars for investors, including over $438 million in 2019 [4].

Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Treace Medical Concepts, Inc. due to allegations of violations of federal securities laws, particularly concerning misleading statements and undisclosed competition impacts on the company's primary product [3][5]. Group 1: Allegations and Impact - The complaint alleges that Treace Medical and its executives made false or misleading statements regarding the demand for their primary product, the Lapiplasty 3D Bunion Correction System, and failed to disclose competitive pressures affecting revenue [5]. - Following a press release on May 7, 2024, the company lowered its full-year 2024 revenue guidance from a range of $220 million to $225 million down to $201 million to $211 million, indicating significant revenue decline [6]. - The stock price of Treace Medical fell by $6.95, or nearly 63%, closing at $4.17 per share on May 8, 2024, following the announcement of the lowered revenue guidance [7]. Group 2: Legal Proceedings - Investors who purchased Treace Medical securities between May 8, 2023, and May 7, 2024, are encouraged to discuss their legal rights and options, with a deadline of June 10, 2025, to seek the role of lead plaintiff in the federal securities class action [2][3]. - The lead plaintiff is defined as the investor with the largest financial interest in the relief sought, who will oversee the litigation on behalf of the class [8]. - Faruqi & Faruqi is also seeking information from whistleblowers, former employees, and shareholders regarding Treace's conduct [9].

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Semler Scientific Inc. and its officers or directors [1] Company Summary - Semler Scientific Inc. filed its annual report for 2024 on February 28, 2025, indicating a risk of a civil complaint from the U.S. Department of Justice related to the False Claims Act [3] - The company received an initial civil investigative demand from the DOJ in July 2017 concerning reimbursement claims for its QuantaFlo device [3] - Settlement discussions with the DOJ in February 2025 were unsuccessful [3] Market Reaction - Following the news of the investigation and potential legal issues, 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 - Pomerantz LLP is investigating claims of potential securities fraud or unlawful business practices involving NeuroPace, Inc. and its officers or directors [1] 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 reaching out to investors of NeuroPace to gather information regarding potential claims related to securities fraud [1] - The firm has a long history in corporate, securities, and antitrust class litigation, having recovered numerous multimillion-dollar damages awards for victims of securities fraud and corporate misconduct [4]

Core Viewpoint - West Pharmaceutical Services, Inc. is facing a class action lawsuit due to significant stock price decline following disappointing revenue and earnings forecasts, attributed to operational challenges and customer losses [2][3]. Group 1: Company Performance - On February 13, 2025, West issued disappointing revenue and earnings forecasts for 2025, citing Contract Manufacturing headwinds and the loss of two major continuous glucose monitoring customers [2]. - The company's SmartDose wearable injector devices are expected to be "margin dilutive" in 2025, prompting the need for steps to improve its economics [2]. - Following the announcement, West's stock price fell by $123.17, or 38.2%, closing at $199.11 per share [2]. Group 2: Lawsuit Details - The class action lawsuit alleges that West made materially false and misleading statements throughout the class period, failing to disclose significant operational issues [3]. - Specific allegations include ongoing destocking across West's high-margin HVP portfolio and operational inefficiencies related to the SmartDose device, which was expected to be a high-margin growth product [3]. - The lawsuit claims that these margin pressures could lead to costly restructuring activities, including exiting contracts with long-standing customers in the continuous glucose monitoring sector [3].