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Apyx Medical Corporation Submits FDA 510(k) for Device Label Expansion of AYON Body Contouring System™ for Power Liposuction
Globenewswire· 2025-10-13 12:00
Core Insights - Apyx Medical Corporation has initiated the nationwide commercial launch of the AYON Body Contouring System, with a focus on expanding its capabilities to include power liposuction through a new 510(k) premarket notification to the FDA [2][3] - The AYON system is designed to integrate various body contouring procedures into a single platform, enhancing workflow for surgeons and potentially improving patient outcomes [3][5] - Apyx Medical is hosting a virtual event on October 14, 2025, featuring key opinion leaders to discuss the commercial launch and advancements of the AYON system [4] Company Overview - Apyx Medical Corporation specializes in advanced energy technology, particularly in the cosmetic surgery market with products like Renuvion and the AYON Body Contouring System [5] - The AYON Body Contouring System is FDA-cleared and combines multiple functionalities, including fat removal and tissue contraction, aimed at providing comprehensive body contouring treatments [5] - The company has received positive feedback from early adopters of the AYON system, indicating strong market interest and potential for growth [3]
Artivion Announces Presentation of Late-Breaking Data from AMDS PERSEVERE and AMDS PROTECT Trials at the 39th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting
Prnewswire· 2025-10-13 12:00
30-day Data from the AMDS PERSEVERE Trial Demonstrates Visceral Malperfusion Resolution in 83%, and Renal Malperfusion Resolution in 74% of Affected Subjects Post-AMDS Implantation Real-World Data from the AMDS PROTECT Trial Validate Statistically Significant Positive Outcomes Demonstrated by the PERSEVERE and DARTS trials , /PRNewswire/ -- Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced data from its AMDS PERSEVERE and PROTECT trials we ...
Stereotaxis & CardioFocus Collaborate to Advance Robotic Pulsed Field Ablation for Cardiac Arrhythmias
Globenewswire· 2025-10-13 11:34
Core Insights - Stereotaxis and CardioFocus have entered a Collaboration Agreement to advance robotic Pulsed Field Ablation (PFA) technology for cardiac arrhythmias [1][2][3] Company Overview - Stereotaxis is a leader in surgical robotics for minimally invasive endovascular interventions, having treated over 150,000 patients globally [5] - CardioFocus specializes in pulsed field ablation treatment for cardiac disorders, particularly atrial fibrillation, and has developed the Centauri PFA System, which has been used on over 9,000 patients in Europe [6] Collaboration Details - The collaboration aims to combine the Centauri PFA System with Stereotaxis' MAGiC robotic cardiac ablation catheter, enhancing the efficiency and safety of cardiac ablation procedures [2][3] - Extensive bench and preclinical testing have shown that the combination of Centauri and MAGiC delivers safe and efficient lesion delivery, including durable lesions in ventricular tissue [3] Clinical and Regulatory Progress - The partnership supports advancing the joint solution to clinical trials, facilitating regulatory compatibility and commercial availability [3] - Both companies anticipate transitioning to first human use and advancing the regulatory process in the coming months [4]
Medtronic Stock's $50 Billion Gift To Investors
Forbes· 2025-10-13 10:45
GLASGOW, SCOTLAND - MAY 22: Dr Catherine Calderwood (2L), Chief Medical Officer for Scotland, Professor Sir Pete Downes, Principal and Vice Chancellor (2R), Dr Vanessa Kay, Co-Director DIHS (R) and Dr Richard Kuntz (L), Senior Vice President, Chief Medical and Scientific Officer of Medtronic open the Dundee Institute for Healthcare Simulation on on May 22, 2018 in Dundee, Scotland. The Institute has been refurbished following a £400k investment from Medtronic, Scottish Enterprise and The University of Dunde ...
ONWARD Medical Provides Preliminary Q3 2025 Update Highlighting Accelerating ARC-EX Adoption in the United States
Globenewswire· 2025-10-13 05:30
Core Insights - ONWARD Medical N.V. has reported strong execution in Q3 2025, with the ARC-EX System now available in over 50 US clinics, indicating accelerating adoption of its neurotechnology solutions [1][4] - The company will provide a comprehensive business and financial update on November 11, 2025 [1] Commercial Traction - A total of 40 ARC-EX Systems were sold in Q3 2025, showcasing continued strong commercial traction for the external spinal cord stimulation technology [4] - More than 50 clinics across the US are now equipped with the ARC-EX System, enhancing its market presence [4] Regulatory Milestones - The ARC-EX System received CE Mark certification, which is intended to improve hand strength and sensation after spinal cord injury, applicable both in clinical settings and at home [4] - The FDA approved an investigational device exemption (IDE) for the ARC-IM System, allowing the initiation of the Empower BP global pivotal study to assess safety and efficacy in addressing blood pressure instability after spinal cord injury [4] Science & Technology Leadership - The company announced the simultaneous publication of two articles in Nature and Nature Medicine, which highlight advances in blood pressure regulation after spinal cord injury, supporting the scientific basis for the ARC-IM System [4] Financial Highlights - For the first time, ONWARD Medical exceeded EUR 1 million in quarterly revenue, marking a significant financial milestone [4]
Douglas Lane Adds $6 Million in J&J Stock Ahead of Earnings and Possible Biotech Deal
The Motley Fool· 2025-10-12 19:14
Core Insights - Douglas Lane & Associates disclosed a purchase of 34,948 shares of Johnson & Johnson, valued at approximately $6 million based on average prices during the third quarter [1][2] - The new stake totals 667,373 shares, with a reported market value of $123.7 million at quarter-end [2] - Johnson & Johnson shares were priced at $190.72, reflecting an 18% increase over the past year, outperforming the S&P 500's 12% gain [3] Financial Performance - Johnson & Johnson reported revenue of $90.6 billion and net income of $22.7 billion for the trailing twelve months [4] - The company has a dividend yield of 2.7% [4] - Last quarter, Johnson & Johnson achieved $23.7 billion in sales, marking a nearly 6% year-over-year increase, with net earnings rising 18% to $5.5 billion [8] Business Overview - Johnson & Johnson operates through a diversified portfolio that includes pharmaceuticals, medical devices, and consumer health products, featuring well-known brands such as Tylenol and Neutrogena [9] - The company's business model focuses on research, development, manufacturing, and global distribution of healthcare products across its three core segments [9] - Primary customers include hospitals, healthcare professionals, retailers, wholesalers, and the general public, with a global reach in both prescription and over-the-counter markets [9] Strategic Developments - Douglas Lane & Associates' investment may indicate confidence ahead of Johnson & Johnson's upcoming third-quarter earnings report, with analysts expecting revenue of about $23.7 billion and earnings of $2.77 per share [7] - Johnson & Johnson is reportedly in talks to acquire Protagonist Therapeutics, which could enhance its immunology pipeline, particularly as its leading product, Stelara, faces market share challenges [11]
Trade Tensions, Market Volatility and Other Key Things to Watch this Week
Yahoo Finance· 2025-10-12 17:00
Friday's trade tensions erupted as President Trump threatened and then imposed an additional 100% tariff on Chinese goods following China's tighter rare-earth export controls, marking a significant escalation that could reshape global supply chains and corporate profit margins. Rare-earth elements are critical for everything from electric vehicles to defense systems, making China's export restrictions a strategic economic weapon that threatens key U.S. technology and manufacturing sectors. The 100% tariff r ...
Here are the 4 big things we're watching in the stock market in the week ahead
CNBC· 2025-10-12 14:01
Financial Earnings - BlackRock is expected to report Q3 earnings per share (EPS) of $11.26 on revenues of $6.2 billion, with a focus on organic base fee growth projected at 7% for the quarter [1] - Wells Fargo is projected to earn $1.55 per share on revenues of $21.15 billion, with particular attention on buyback activity and future capital return plans [1] - Goldman Sachs is expected to report EPS of $11 on revenue of $14.1 billion, with a consensus for a 15.4% year-over-year increase in investment banking fees [1] Healthcare Sector - Abbott Laboratories is expected to earn $1.30 per share on revenue of $11.4 billion, with a critical focus on the impact of China's volume-based procurement policy on its diagnostics segment [1] - Abbott's medical devices segment has consistently beaten Wall Street expectations for 10 consecutive quarters, particularly in its continuous glucose monitor business [1] Washington Updates - The market is closely monitoring the ongoing government shutdown and its potential impact on economic growth, with the Bureau of Labor Statistics calling back employees for the consumer price index report [2] - President Trump's announcement of a 100% additional tariff on Chinese imports starting Nov. 1 has heightened trade tensions, affecting market sentiment [2] Salesforce and AI Tools - Salesforce's annual Dreamforce conference is anticipated to provide insights into the value of its AI tools, with a focus on whether these tools can drive revenue growth amid concerns about AI's impact on traditional software models [2]
Here's How You Can Earn $100 In Passive Income By Investing In Becton Dickinson Stock
Yahoo Finance· 2025-10-12 12:23
Benzinga and Yahoo Finance LLC may earn commission or revenue on some items through the links below. Becton, Dickinson and Co. (NYSE:BDX) is a multinational medical technology company that manufactures and sells medical devices, instruments, and reagents for healthcare institutions, life science researchers, and the general public worldwide. It will report its Q4 2025 earnings on Nov. 6. Wall Street analysts expect the company to post EPS of $3.92, up from $3.81 in the prior-year period. According to data ...
Zimmer Biomet Q3 Earnings To Highlight Innovation And Growth - Why I Think It's A Buy
Seeking Alpha· 2025-10-12 08:24
Core Insights - Zimmer Biomet Holdings (NYSE: ZBH) has experienced a challenging stock performance over the past month, recording single-digit losses, similar to the losses observed in 2025 [1] Company Performance - The stock has faced single-digit losses recently, indicating a tough market environment for the company [1] Analyst Background - Gamu Dave Innocent Pasi, a financial professional with extensive experience in investment research, has a strong background in analyzing financial statements and capital markets [1] - He is recognized for providing actionable trading ideas and well-researched investment recommendations, contributing to reputable publications [1] - Pasi holds a Postgraduate Executive Certificate in Investments and Portfolio Management and a Bachelor of Business Studies Honors degree in Banking and Finance [1] Investment Philosophy - Pasi is passionate about innovative solutions that promote financial inclusion, sustainability, and measurable social impact [1] - He advocates for Responsible Investment and actively incorporates Environmental, Social, and Governance (ESG) principles in investment decision-making [1]