BROSSARD, Quebec, July 16, 2025 (GLOBE NEWSWIRE) -- Diagnos Inc. (“DIAGNOS” or the “Corporation”) (TSX Venture: ADK, OTCQB: DGNOF, FWB: 4D4A), a Canadian leader in artificial intelligence (AI) for the early detection of retinal and systemic diseases, is proud to announce that it has formally submitted a Pre-Submission (Q-sub) to the U.S. Food and Drug Administration (FDA) for its flagship CARA System. This filing marks the first strategic step toward regulatory clearance and commercial deployment in the U.S ...

Core Insights - SeaStar Medical Holding Corporation has expanded its QUELIMMUNE therapy user base by adding a recognized Texas-based children's hospital, which is significant for treating pediatric patients with ultra-rare Acute Kidney Injury (AKI) [1][5] - The QUELIMMUNE therapy was approved by the FDA in 2024 under a Humanitarian Device Exemption to address life-threatening AKI due to sepsis or septic conditions [1][5] - The SAVE Surveillance Registry has been established to monitor safety and outcomes for pediatric patients treated with QUELIMMUNE compared to standard care, with early data analysis expected to be presented at an upcoming medical conference [2][3] Company Developments - SeaStar Medical is making progress in introducing QUELIMMUNE to top children's hospitals in the U.S. and is collecting significant data on its performance through the SAVE Surveillance Registry [3] - The company is conducting the NEUTRALIZE-AKI pivotal trial, which is evaluating the safety and efficacy of the Selective Cytopheretic Device (SCD) therapy in adults with AKI, with 119 out of 200 planned subjects enrolled [3][9] - SeaStar Medical has received FDA Breakthrough Device Designation for QUELIMMUNE and five other indications, which may facilitate faster approval and better reimbursement dynamics [11] Clinical Outcomes - Data from clinical studies indicate a 77% survival rate for patients treated with QUELIMMUNE, representing a 50% reduction in loss of life compared to historical data, with 87.5% of survivors achieving normal kidney function by Day 60 post-ICU discharge [7] - The NEUTRALIZE-AKI trial's primary endpoint includes a composite of 90-day mortality or dialysis dependency, with secondary endpoints assessing various health outcomes [9] Industry Context - AKI is characterized by a sudden loss of kidney function and can lead to severe complications, including multi-organ dysfunction and increased healthcare costs due to prolonged ICU stays and reliance on dialysis [4] - The QUELIMMUNE therapy is specifically designed for pediatric patients weighing 10 kilograms or more who are on antibiotics and receiving Renal Replacement Therapy in the ICU [5][10] - SeaStar Medical's SCD therapy aims to modulate the immune response to prevent destructive hyperinflammation, which is critical for improving outcomes in patients with AKI and other related conditions [10]

Q2 2025 Financial Performance - Worldwide sales reached $23.7 billion, a 5.8% increase compared to Q2 2024, with operational sales growth of 4.6%[47] - U S sales increased by 7.8% to $13.5 billion in Q2 2025 from $12.6 billion in Q2 2024[47] - Adjusted earnings were $6.7 billion, and adjusted EPS was $2.77[49] - GAAP net earnings increased to $5.5 billion, a rise of 18.2%[49] Innovative Medicine - Innovative Medicine sales reached $15.202 billion, with operational growth of 3.8%[51] - Oncology sales grew by 22.3% operationally, reaching $6.312 billion[51] - Immunology sales declined by 16% operationally, totaling $3.993 billion, impacted by STELARA biosimilar competition[51] MedTech - MedTech sales were $8.541 billion, with operational growth of 6.1%[53] - Cardiovascular sales increased by 22.3% operationally, reaching $2.313 billion[53] - Orthopaedics sales decreased by 1.6% operationally, totaling $2.305 billion[53] Guidance - The company increased its operational sales guidance for 2025 to 4.8% and adjusted operational EPS guidance to 7.0% (midpoints)[62] - Operational sales are projected to be between $92.7 billion and $93.1 billion[62]

Group 1 - Lucid Diagnostics Inc. announced a virtual public meeting on September 4, 2025, to discuss the reconsideration of Local Coverage Determination (LCD) L39256 for its EsoGuard® Esophageal DNA Test [1] - The meeting will involve Medicare Administrative Contractors and medical experts, focusing on the clinical literature related to esophageal precancer testing [2] - Lucid's CEO expressed optimism about the meeting's potential to lead to a positive Medicare coverage policy outcome, citing broad consensus in the GI community regarding the clinical utility of EsoGuard [2] Group 2 - Lucid Diagnostics is a commercial-stage company focused on cancer prevention, specifically targeting patients with gastroesophageal reflux disease (GERD) at risk of esophageal precancer [3] - The EsoGuard® Esophageal DNA Test is designed for early detection of esophageal precancer through a noninvasive procedure, representing a significant advancement in cancer prevention tools [3]

Core Insights - CVRx, Inc. announced that the Centers for Medicare and Medicaid Services (CMS) proposed to maintain the Barostim implant procedure under the New Technology Ambulatory Payment Classification (APC) 1580, with an outpatient payment of approximately $45,000 [1] - The proposal follows positive reimbursement developments, including Barostim's assignment to a higher paying MS-DRG for inpatient procedures and its transition from Category III to Category I CPT codes for physician payments starting January 1, 2026 [2] - The updates in reimbursement are expected to enhance access to Barostim for patients with heart failure, supporting its broader market adoption and long-term growth [3] Company Overview - CVRx is a commercial-stage medical device company focused on innovative neuromodulation solutions for cardiovascular diseases [4] - Barostim is the first FDA-approved medical technology that uses neuromodulation to alleviate symptoms in heart failure patients, delivering electrical pulses to baroreceptors in the carotid artery [4] - Barostim has received FDA Breakthrough Device designation and is compliant with EU Medical Device Regulation, holding CE Mark approval for heart failure and resistant hypertension in the European Economic Area [4]

Company Overview - Venus Concept Inc. is a global leader in medical aesthetic technology, offering a wide range of minimally invasive and non-invasive products for aesthetic and hair restoration [4] - The company operates in over 60 countries and has 9 direct markets, showcasing its extensive reach in the industry [4] - Venus Concept's product portfolio includes various aesthetic device platforms and hair restoration systems, such as NeoGraft® and the ARTAS iX® Robotic Hair Restoration system [4] Financial Results Announcement - The company will release its second quarter fiscal year 2025 financial results after market close on August 14, 2025 [1] - A conference call will be held at 5:00 p.m. Eastern Time on the same day to discuss the results and answer questions [2] - For those unable to attend, a replay of the call will be available for two weeks, and a webcast will be archived on the company's investor relations website [3] Investor Relations - Investor relations contact for Venus Concept is managed by ICR Healthcare, with Mike Piccinino, CFA, as the point of contact [5]

About BC Children's Hospital BC Children's Hospital is a pediatric teaching and research hospital in Vancouver, British Columbia. It provides world-leading care for its patients and is recognized for its innovative research in child health. The Global POISE study is spearheaded by principal investigators Dr. Anthony Cooper and Dr. Kishore Mulpuri, two orthopedic surgeons of BC Children's Hospital. About OrthoPediatrics Corp. Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on ad ...

Daniel Nadler started OpenEvidence to help physicians sort through a deluge of medical research. Now, he’s raised $210 million at a $3.5 billion valuation. (Photo: Mauricio Candela for Forbes) https://t.co/Ksq0RkAzat https://t.co/1ROuaJOG3Z ...

Daniel Nadler started OpenEvidence to help physicians sort through a deluge of medical research. Now, he’s raised $210 million at a $3.5 billion valuation.FULL STORY: https://t.co/QNHZDQfoiL(Photo: Mauricio Candela for Forbes) https://t.co/FU0teKrDkE ...

Core Insights - Jin Medical International Ltd. has launched production at its new intelligent manufacturing facility in Chuzhou, Anhui, China, aiming to enhance its rehabilitation medical equipment supply chain [1][2] - The facility is equipped to produce 200,000 units annually, adhering to Japanese Industrial Standards (JIS) for quality [2] - Jin Medical's product range includes ultra-light wheelchairs, competition-grade equipment, micro hyperbaric oxygen chambers, and beauty devices, reflecting a commitment to meet diverse health needs [3] Company Overview - Founded in 2006, Jin Medical is headquartered in Changzhou, Jiangsu Province, China, and specializes in designing, developing, and manufacturing products for rehabilitation and elderly care [6] - The company operates two existing manufacturing plants totaling approximately 230,000 square feet and is establishing a new facility of 430,000 square feet in Chuzhou [6] - Jin Medical collaborates with over 40 distributors in China and more than 20 international distributors, primarily selling its wheelchair products in Japan and China [6] Strategic Vision - The CEO of Jin Medical emphasized a shift in rehabilitation technology towards enhancing quality of life, leveraging intelligent manufacturing to meet global health demands [4] - The company is actively testing new electric wheelchairs for distribution in senior care communities and rehabilitation centers across various international locations [4] - Jin Medical aims to bridge the gap between East and West in rehabilitation technology, positioning itself for future growth on the global stage [5]