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Intuitive demonstrates telesurgery capabilities
Globenewswire· 2025-07-16 13:16
Core Viewpoint - Intuitive has successfully demonstrated its telesurgery capabilities by connecting two surgeons remotely to perform a transatlantic surgery at the Society of Robotic Surgery conference, showcasing advancements in robotic-assisted surgery technology [1][2][4]. Company Overview - Intuitive, headquartered in Sunnyvale, California, is a leader in minimally invasive care and robotic surgery, with a focus on improving patient outcomes and care delivery efficiency [11]. - The company has developed the da Vinci surgical system, which has been used in nearly 17 million procedures over 30 years, training almost 90,000 surgeons [8]. Telesurgery Demonstration - The demonstration involved Dr. Doug Stoddard in Georgia and Dr. Andrea Pakula in France, using a dual console da Vinci 5 system to perform surgery on an advanced tissue model [2][3]. - The surgeons were able to exchange control of surgical instruments remotely, utilizing Force Feedback technology to simulate the sensation of operating on live tissue despite being over 4,000 miles apart [3]. Future of Telesurgery - Intuitive's CEO emphasized the potential of telesurgery to enhance patient access to care, while also noting the importance of careful development in infrastructure and technology to ensure safety and reliability [4][6]. - The company is focused on building a robust network infrastructure to support telesurgery, rather than being the first to market [7]. Technology Development - The telesurgery software demonstrated is still in development and not yet cleared for sale or use in the U.S. or EU, indicating ongoing efforts to ensure safety and effectiveness [9]. - Intuitive's telecollaboration suite includes telementoring and teleproctoring, aimed at improving clinical outcomes and reducing care costs [6].
SeaStar Medical Grows Customer Base and Expands QUELIMMUNE Surveillance Registry
Globenewswire· 2025-07-16 12:45
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]
J&J(JNJ) - 2025 Q2 - Earnings Call Presentation
2025-07-16 12:30
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]
CVRx Announces Positive News on Outpatient Payment for Barostim
Globenewswire· 2025-07-16 11:30
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]
Global POISE Study Reaches Milestone of 600 Orthopedic Implants in Pediatric Patients, Advancing Research on the Safety and Efficacy of OrthoPediatrics® Products
GlobeNewswire News Room· 2025-07-16 11:00
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 ...
Robbins LLP is Investigating the Officers and Directors of RxSight, Inc. (RXST) to Determine if They Breached Fiduciary Duties Owed to Shareholders
GlobeNewswire News Room· 2025-07-15 21:18
Core Insights - Robbins LLP is investigating RxSight, Inc. for potential violations of securities laws and breaches of fiduciary duties by certain officers and directors [1] - RxSight, Inc. is a commercial-stage medical technology company focused on the research, development, manufacture, and sale of light adjustable intraocular lenses (LAL) for cataract surgery in the United States [1] Company Overview - RxSight, Inc. operates in the medical technology sector, specifically in the field of ophthalmology, providing innovative solutions for cataract surgery [1] - The company is publicly traded on NASDAQ under the ticker RXST [1] Legal Context - The investigation by Robbins LLP suggests potential legal challenges for RxSight, which may impact shareholder confidence and the company's market performance [1][2] - Shareholders who have incurred losses are encouraged to seek information regarding their rights [2]
Why AngioDynamics Stock Popped, Then Dropped Today
The Motley Fool· 2025-07-15 20:42
AngioDynamics' big Q4 earnings beat wasn't as impressive as it first seemed.Tuesday started off well for AngioDynamics (ANGO -10.18%), maker of such medical devices as the NanoKnife tool for "electrocuting" cancer, as well as multiple devices for treating peripheral vascular disease. In the morning, AngioDynamics reported stronger-than-expected Q4 2025 sales and earnings, with sales of $80.2 million and an adjusted loss of $0.03 per share (instead of the $0.12-per-share forecast).By the end of the day, howe ...
Globus Medical Introduces DuraPro™ with Navigation, a Next-Generation, Oscillating System Designed to Safeguard Delicate Tissue
Globenewswire· 2025-07-15 20:15
Core Viewpoint - Globus Medical, Inc. has expanded its Excelsius™ navigation capabilities with the introduction of the DuraPro™ oscillating system, aimed at enhancing procedural workflows through improved safety and efficiency [1][5]. Group 1: Product Innovation - The DuraPro™ system is designed to revolutionize the $550 million high-speed drill market with next-generation oscillation technology [2]. - DuraPro™ helps prevent soft tissue wrapping while providing a natural sensation similar to conventional spinning drills, allowing for efficient and accurate bone removal [3]. - The system features anti-skiving pilot hole drilling, maintaining drill tip trajectories and facilitating thorough discectomies [3]. Group 2: Integration and Workflow Enhancement - DuraPro™ integrates seamlessly with ExcelsiusGPS™ and ExcelsiusHub™, supporting accuracy and efficiency in both navigated and non-navigated workflows [3]. - The newly launched Verzera™ system, also integrated with ExcelsiusGPS and ExcelsiusHub, enhances existing workflows for surgeons by allowing navigation during bone removal procedures [4]. Group 3: Commitment to Clinical Needs - The expanded Power Portfolio reflects Globus Medical's commitment to addressing unmet clinical needs and providing surgeons with enhanced confidence through integrated technology [5].
Sanara MedTech to Report Second Quarter 2025 Financial Results on August 13, 2025
Globenewswire· 2025-07-15 20:05
FORT WORTH, TX, July 15, 2025 (GLOBE NEWSWIRE) -- Sanara MedTech Inc. (“Sanara,” or the “Company”) (Nasdaq: SMTI), a medical technology company focused on developing and commercializing transformative technologies to improve clinical outcomes and reduce healthcare expenditures in the surgical, chronic wound and skin markets, today announced it will report its second quarter 2025 financial results on Wednesday, August 13, 2025 before the U.S. financial markets open. The Company will host a conference call an ...
Nuwellis Secures New U.S. Patent, Strengthening Its Position as a Leader in Fluid Management Innovation
Globenewswire· 2025-07-15 20:05
Core Insights - Nuwellis, Inc. has been granted U.S. Patent No. 12,357,734 for innovations in blood filtering and fluid management, enhancing its intellectual property portfolio [1][3] - The patent addresses inaccuracies in fluid balance calculations in continuous renal replacement therapy (CRRT) systems by incorporating fluid density, which can lead to clinically relevant errors if uncorrected [2] - The CEO of Nuwellis emphasized the importance of expanding the intellectual property portfolio as a strategy for long-term value creation through innovation [3] Company Overview - Nuwellis, Inc. is a medical technology company focused on fluid management solutions, particularly the Aquadex SmartFlow system for ultrafiltration therapy [5] - The Aquadex SmartFlow system is designed for patients suffering from fluid overload, providing a clinically proven method for excess fluid removal [6] - The company is headquartered in Minneapolis and has a wholly owned subsidiary in Ireland [5] Patent Details - The newly issued patent covers methods that allow CRRT systems to account for fluid density variations, improving volumetric flow tracking accuracy [2] - This innovation is crucial for enhancing the performance of extracorporeal fluid management systems [3]