Medical Technology
Search documents
Northwest Kidney Centers and Outset Medical Announce Collaboration to Grow Home Hemodialysis
Globenewswire· 2025-09-03 13:00
Core Insights - Northwest Kidney Centers collaborates with Outset Medical to enhance access to home hemodialysis through the integration of the Tablo Hemodialysis System [1][2][3] - The partnership aims to improve patient independence and quality of life by providing an intuitive and user-friendly dialysis solution [2][3][4] Company Overview - Northwest Kidney Centers is a nonprofit organization established in 1962, recognized as the first outpatient dialysis provider and currently the eighth-largest in the U.S., serving over 2,000 patients annually [5][6] - Outset Medical is a medical technology company focused on transforming the dialysis experience, with the Tablo system being FDA-cleared for use from hospital to home [7][8] Product Features - The Tablo Hemodialysis System operates using standard tap water and electricity, simplifying the dialysis process and eliminating the need for complex infrastructure [2][3] - It features a touchscreen interface, automated setup, and cloud connectivity, making it accessible for both patients and healthcare providers [2][8] Impact on Patient Care - The collaboration is expected to empower patients by providing a more sustainable and easier-to-learn dialysis option, aligning with modern lifestyles [3][4] - Patients who participated in the pilot phase reported increased engagement and confidence in their treatment due to the system's intuitive design [2][3]
Biotricity and B-Secur Target the Consumer Wearables Market with Expansion of Next-Gen Cardiac Monitoring Platform
Globenewswire· 2025-09-03 12:15
Core Insights - Biotricity Inc. and B-Secur are enhancing their joint cardiac monitoring platform to support ECG data from consumer wearables, transforming the consumer wearables market [1][2][3] - The device-neutral platform launched in early 2025 allows seamless integration of data from various smart devices into Biotricity's cloud-based medical workflow [2][4] - This advancement positions Biotricity and B-Secur as leaders in digital cardiovascular innovation, addressing the growing demand for preventive cardiovascular solutions [3][5] Company Overview - Biotricity aims to make high-quality cardiac care accessible through its collaboration with B-Secur, introducing clinical-grade heart monitoring to consumer wearables [4][7] - B-Secur specializes in advanced biosensing technology, providing medical-grade ECG data for faster diagnosis and management of health conditions [6] - Both companies are focused on bridging the gap between consumer devices and clinical care, enhancing preventive and personal care solutions [4][7] Market Context - Cardiovascular disease accounts for 1 in 3 deaths globally and is projected to triple costs to $1.8 trillion by 2050, highlighting the urgent need for scalable preventive technologies [5] - The integration of consumer wearables into clinical pathways is expected to improve long-term health outcomes while reducing healthcare costs [5]
SMLR Stockholder Notice: Shareholder Rights Law Firm Robbins LLP Reminds Investors of the Semler Scientific, Inc. Class Action Lawsuit
GlobeNewswire News Room· 2025-09-02 22:00
Core Viewpoint - A class action lawsuit has been filed against Semler Scientific, Inc. for failing to disclose an investigation by the U.S. Department of Justice regarding potential violations of the False Claims Act [1][2]. Allegations and Investigations - The lawsuit alleges that Semler Scientific did not disclose a material investigation by the DOJ into violations of the False Claims Act during the class period from March 10, 2021, to April 15, 2025 [2]. - On February 28, 2025, Semler Scientific revealed it had received an initial civil investigative demand from the DOJ in July 2017, investigating whether the company violated the False Claims Act by marketing certain tests as reimbursable by Medicare [3]. - Following unsuccessful settlement discussions with the DOJ on February 11, 2025, there was a risk of a civil lawsuit being filed, which led to a significant drop in the company's stock price [3]. Settlement and Financial Impact - On April 15, 2025, Semler Scientific announced it had reached a settlement agreement with the DOJ for $29.75 million, excluding attorney fees, but noted that further payments might be necessary and the risk of a lawsuit still exists [4]. - The announcement of the settlement led to a further decline in Semler Scientific's stock price, falling by $3.40 per share, or 9.88%, to close at $31.00 on April 16, 2025 [4]. Class Action Participation - Shareholders of Semler Scientific may be eligible to participate in the class action lawsuit, with a deadline to submit paperwork by October 28, 2025, to serve as lead plaintiff [5].
Sanara MedTech Inc. Announces Chief Executive Officer Transition
Globenewswire· 2025-09-02 20:30
Core Viewpoint - Sanara MedTech Inc. has appointed Seth Yon as President and Chief Executive Officer, effective September 15, 2025, succeeding Ron Nixon, who will remain as Executive Chairman [1][2]. Leadership Transition - The Board of Directors unanimously voted to appoint Seth Yon, highlighting his strategic leadership and proven track record over the past seven years, during which Sanara achieved a compounded annual net revenue growth of 53% over the last three fiscal years [2]. - Ron Nixon emphasized that this transition is part of a long-term initiative to strengthen the senior leadership team for future success in the market [2]. Seth Yon's Background - Seth Yon joined Sanara in March 2018 and has held various senior management roles, including Director of Sales, National Sales Director, and President of Commercial, before becoming President and Chief Commercial Officer [2][3]. - His experience includes leading the development of sales processes and metrics, contributing to significant growth in the Sanara Surgical segment [2]. Company Overview - Sanara MedTech Inc. focuses on developing and commercializing transformative medical technologies aimed at improving clinical outcomes and reducing healthcare costs in surgical, chronic wound, and skin markets [4][5]. - The company markets a range of products, including CellerateRX Surgical Activated Collagen and various advanced biologic products, primarily in the North American advanced wound care and surgical tissue repair markets [4][5].
Sight Sciences Announces Recognition of the TearCare® System in TFOS DEWS III Global Dry Eye Guidelines Published in AJO
Globenewswire· 2025-09-02 20:05
Core Insights - The TearCare System by Sight Sciences has been included in the new Dry Eye Workshop (DEWS) III report, which is a significant validation of its clinical efficacy in managing dry eye disease (DED) [1][2] - The DEWS III report is recognized as a primary standard in evidence-based management of DED, highlighting the importance of TearCare in treating meibomian gland disease (MGD) [2][3] Company Overview - Sight Sciences is an eyecare technology company focused on developing innovative interventional solutions aimed at transforming patient care and improving lives [4] - The company offers minimally invasive technologies, including the OMNI Surgical System and SION Surgical System, targeting prevalent eye diseases such as glaucoma and dry eye disease [4] Clinical Evidence - The six-month SAHARA randomized controlled trial demonstrated that two treatments with the TearCare system were clinically superior in improving Tear Breakup Time (TBUT) and gland function compared to Restasis, while being non-inferior in Ocular Surface Disease Index (OSDI) [6] - The OLYMPIA randomized controlled trial showed that a single TearCare treatment significantly alleviated signs and symptoms of DED, with greater improvements noted in subjects with more severe disease compared to LipiFlow [6]
InMode to Present at Baird 2025 Global Healthcare Conference
Prnewswire· 2025-09-02 12:30
Company Overview - InMode Ltd. is a leading global provider of innovative medical technologies, focusing on developing, manufacturing, and marketing devices that utilize novel radio frequency (RF) technology [3] - The company aims to enable new surgical procedures and enhance existing treatments across various medical fields, including plastic surgery, gynecology, dermatology, otolaryngology, and ophthalmology [3] Upcoming Events - Yair Malca, the Chief Financial Officer of InMode, will present in-person at the Baird 2025 Global Healthcare Conference in New York on September 10, 2025 [1] - The presentation will be moderated by Jeff Johnson, a Senior Research Analyst, and is scheduled for 8:30 am Eastern Time [2] - InMode will also conduct one-on-one investor meetings on the same day, with scheduling available through Baird representatives [2]
ONWARD Medical Demonstrates Commercial Traction and Advances Pipeline in the First Half of 2025
Globenewswire· 2025-09-02 05:30
Core Insights - ONWARD Medical N.V. reported strong demand for its ARC-EX System in the US and achieved FDA IDE approval for the Empower BP study, indicating positive commercial and regulatory momentum [2][6]. Commercial Traction - The company successfully sold 30 ARC-EX Systems to US clinics in the first half of 2025, meeting its sales targets and demonstrating strong demand [3][7]. - Access to US government procurement platforms was secured, allowing Veterans Affairs and other government buyers to purchase the ARC-EX System [4]. Regulatory Milestones - ONWARD submitted a 510(k) application to the FDA for home use of the ARC-EX System and filed for CE Mark certification in the EU [5][7]. - The FDA approved an investigational device exemption (IDE) for the ARC-IM System, enabling the start of the Empower BP study [6][7]. Science & Technology Leadership - The Pathfinder2 study showed that sustained access to ARC-EX Therapy leads to continued functional improvements after one year of treatment [9]. - The first human implant of the investigational ARC-IM Lumbar Lead was successfully completed, aimed at restoring mobility [11]. Financial Highlights - The company reported EUR 1.2 million in revenue for the first half of 2025, with an operating loss of EUR 20.0 million [15][17]. - The cash position at the end of June 2025 was EUR 40.9 million, up from EUR 32.1 million at the end of 2024 [17]. Outlook - Continued strong demand for the ARC-EX System and positive user feedback suggest the company is on track to meet its sales targets for Q3 2025 [18]. - The company anticipates first patient enrollment in the Empower BP study before the end of the year and plans additional implants of its ARC-IM and ARC-BCI systems [19].
Is it Apt to Hold Bio-Rad Stock in Your Portfolio Now?
ZACKS· 2025-09-01 15:20
Core Insights - Bio-Rad Laboratories, Inc. (BIO) is positioned for growth due to strong demand for its QX600 Droplet Digital PCR (ddPCR) platform and robust performance in Clinical Diagnostics [1][4] - The company has experienced a decline in share price by 11.7% over the past year, contrasting with the industry's growth of 3.4% and the S&P 500's rise of 15.7% [2] - Bio-Rad's market capitalization stands at $8.06 billion, with earnings surpassing estimates in three of the last four quarters, averaging a surprise of 34.5% [2] Growth Drivers - The QX600 ddPCR platform is expanding, with new assay enhancements and the acquisition of Stilla Technologies aimed at entering new molecular testing markets [4] - The introduction of the IH-500 NEXT System in 2023 has strengthened Bio-Rad's position in Clinical Diagnostics, maintaining strong demand for quality control and immunology products [5] - The company expects mid-single-digit revenue growth for its ddPCR portfolio by 2025 following the Stilla acquisition [4] Financial Health - Bio-Rad reported cash and cash equivalents of $1.37 billion and only $1 million in short-term debt at the end of Q2 2025, indicating strong solvency [6] - Total debt remained stable at $1.20 billion, which is lower than the cash and cash equivalents [6] Challenges - The company faces challenges from weak end markets, particularly in the biopharma sector, with a 1.7% year-over-year revenue decline in its core Life Science Group [9] - Competitive pressure is significant, with large corporations and startups competing aggressively, limiting Bio-Rad's pricing strategies [9] - The proposed reductions in federal funding for institutions within Bio-Rad's customer base have led to cautious capital allocation among customers [9] Earnings Estimates - The Zacks Consensus Estimate for Bio-Rad's 2025 earnings per share (EPS) has increased by 5% to $9.69, while revenue estimates are projected at $2.58 billion, reflecting a modest 0.6% increase from the previous year [10]
Investor Alert: Robbins LLP Informs Investors that a Class Action Lawsuit Has Been Filed Against Semler Scientific, Inc.
Prnewswire· 2025-08-29 21:14
Core Viewpoint - A class action lawsuit has been filed against Semler Scientific, Inc. for failing to disclose an investigation by the U.S. Department of Justice regarding potential violations of the False Claims Act [1][2]. Allegations - The lawsuit alleges that Semler Scientific did not disclose a material investigation by the DOJ into possible violations of the False Claims Act during the class period from March 10, 2021, to April 15, 2025 [2]. - On February 28, 2025, Semler Scientific revealed it had received an initial civil investigative demand from the DOJ in July 2017, investigating whether the company violated the False Claims Act by marketing certain tests as reimbursable by Medicare [3]. - Following unsuccessful settlement discussions with the DOJ on February 11, 2025, the company faced a risk of a civil lawsuit, leading to a stock price drop of $4.03, or 9.38%, closing at $38.89 on March 3, 2025 [3]. Settlement and Financial Impact - On April 15, 2025, Semler Scientific reported to the SEC that it had reached a settlement agreement with the DOJ for $29.75 million, excluding attorney fees, but noted that further payments might be necessary and the risk of a DOJ lawsuit still exists [4]. - Following the settlement announcement, Semler Scientific's stock price fell by $3.40 per share, or 9.88%, closing at $31.00 on April 16, 2025 [4].
Integra LifeSciences Leadership to Present at Wells Fargo and Morgan Stanley Healthcare Investor Conferences
Globenewswire· 2025-08-29 20:30
Group 1 - Integra LifeSciences Holdings Corporation announced that CEO Mojdeh Poul and CFO Lea Knight will present at two upcoming investor healthcare conferences [1] - The conferences include the Wells Fargo Healthcare Conference on September 3, 2025, and the Morgan Stanley Healthcare Conference on September 10, 2025 [3] - A live webcast of the presentations will be available on the Integra LifeSciences investor relations website [1]