Core Viewpoint - ClearPoint Neuro, Inc. has received EU MDR Certification for its ClearPoint Navigation Software Version 3.0.2, which is expected to enhance its global navigation platform and improve training and hospital IT support [1]. Group 1 - The company is a global device, cell, and gene therapy-enabling firm focused on precise navigation to the brain and spine [1]. - The achievement of CE Mark for the ClearPoint Navigation 3.0.2 software signifies a significant milestone for the company [1]. - The Chief Operating Officer, Mazin Sabra, emphasized the importance of this certification in unifying the global navigation platform [1].

Core Insights - CVRx, Inc. has initiated the BENEFIT-HF clinical trial, which is expected to be one of the largest therapeutic cardiac device trials for heart failure, supported by CMS Category B IDE coverage [1][4][5] - The trial aims to evaluate the Barostim™ device in a significantly expanded heart failure population, potentially tripling the indicated patient population for the device [3][5] Company Overview - CVRx, Inc. is a medical device company focused on developing innovative neuromodulation solutions for cardiovascular diseases [6] - Barostim™ is the first FDA-approved medical technology that uses neuromodulation to alleviate heart failure symptoms, receiving FDA Breakthrough Device designation in 2019 [2][6] Clinical Trial Details - The BENEFIT-HF trial will randomize 2,500 patients across approximately 150 centers in the U.S. and Germany, with the primary endpoint being a composite of all-cause mortality and heart failure decompensation events [3] - Enrollment for the trial is expected to begin in the first half of 2026 [3] Patient Population Criteria - The trial will include patients who remain symptomatic after receiving optimized guideline-directed medical and device therapies, have a left ventricular ejection fraction (LVEF) <50%, and NT-proBNP levels <5,000 pg/mL [7]

Core Insights - Abbott Laboratories has projected that its first-quarter profit will fall short of Wall Street expectations due to the need to offer discounts on nutrition products to attract price-sensitive customers, resulting in a significant drop in share prices [1][4] Financial Performance - The company anticipates adjusted earnings per share for the first quarter to be between $1.12 and $1.18, compared to the Wall Street average estimate of $1.19 [2] - In the fourth quarter, Abbott reported sales of $11.5 billion, which was below the average analyst estimate of $11.8 billion. Nutrition sales were particularly disappointing at $1.9 billion, falling short of the $2.19 billion estimate [3] Business Strategy - Abbott is shifting its nutrition business focus towards sustainable volume growth, which may impact performance in the first half of the year but is expected to position the business for long-term success. The company plans to launch eight new nutrition products in 2026 [5] Market Dynamics - The adult nutrition unit, which includes protein-focused drinks for individuals on weight-loss medications, has seen growth in recent quarters. However, the company faces challenges due to lawsuits alleging that its baby formula may cause necrotizing enterocolitis (NEC) in premature infants [6] Segment Performance - Abbott's largest business unit, medical devices, generated $5.67 billion in sales during the fourth quarter, aligning with estimates. This division includes products that assist diabetics in monitoring blood sugar levels [7] - The diagnostics unit has experienced a decline in demand following the pandemic, particularly for Covid-19 tests. Abbott has agreed to acquire Exact Sciences Corp. for approximately $21 billion, which is expected to enhance its diagnostics business by providing access to cancer screening tests [8]

Core Viewpoint - Anteris Technologies has secured a $90 million strategic investment from Medtronic, which follows a $320 million underwritten offering of common stock, aimed at advancing the global pivotal PARADIGM trial and commercializing the DurAVR® Transcatheter Heart Valve [1][3]. Group 1: Investment and Collaboration - The investment from Medtronic is seen as a significant milestone for Anteris, validating its program in the capital markets and indicating potential future collaborations [3]. - Anteris and Medtronic share a vision of advancing the Transcatheter Aortic Valve Replacement (TAVR) market through improved clinical science and valve design, focusing on durability and long-term patient outcomes [2][3]. Group 2: PARADIGM Trial - The PARADIGM Trial is a randomized controlled trial designed to evaluate the safety and effectiveness of the DurAVR® THV against existing TAVR options, with an enrollment target of approximately 1,000 patients [4][5]. - The trial will assess non-inferiority based on a primary composite endpoint that includes all-cause mortality, all strokes, and cardiovascular hospitalizations at one year post-procedure [5]. - Recruitment for the PARADIGM Trial has already begun, with the first patients enrolled in the fourth quarter of 2025 [6]. Group 3: Product Overview - Anteris' lead product, the DurAVR® Transcatheter Heart Valve, is designed to treat aortic stenosis and is the first biomimetic valve, aiming to replicate the performance of a healthy aortic valve [8]. - The DurAVR® THV is constructed from Anteris' patented ADAPT® tissue technology, which has been clinically used for over 10 years and is FDA-cleared, having been distributed to over 55,000 patients globally [8].

MINNEAPOLIS and BRISBANE, Australia, Jan. 22, 2026 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (“Anteris” or the “Company”) (NASDAQ: AVR, ASX: AVR), a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today announced the closing of its underwritten public offering (the “Offering”) of 40,000,000 shares of its common stock, including the exercise in full of the underwriters’ option to purchase addit ...

Core Viewpoint - Abbott Laboratories' shares fell over 9% intra-day following fourth-quarter earnings that met expectations but missed revenue targets, along with weaker guidance for the first quarter [1] Financial Performance - Adjusted earnings per share for the quarter were $1.50, aligning with analyst estimates [2] - Revenue totaled $11.46 billion, below the consensus forecast of $11.8 billion, with total sales increasing by 4.4% on a reported basis and 3.0% organically [2] - Organic growth, excluding COVID-19 testing-related sales, was 3.8% compared to the prior-year quarter [2] Segment Performance - The Medical Devices segment showed strong results, with revenue increasing by 12.3% to $5.68 billion [3] - Diabetes Care sales, including continuous glucose monitoring products, rose by 14.5% to $2.13 billion [3] - Nutrition revenue declined by 8.9% to $1.94 billion due to lower volumes and strategic pricing actions [3] - Diagnostics revenue fell by 2.5% to $2.46 billion, attributed to reduced demand for COVID-19 testing [3] Future Guidance - For the first quarter of 2026, Abbott projected adjusted earnings per share of $1.12 to $1.18, below the analyst consensus of $1.20 [2] - For the full year 2026, Abbott forecasted organic sales growth of 6.5% to 7.5% and adjusted earnings per share of $5.55 to $5.80, exceeding the analyst consensus of $5.17 and representing approximately 10% growth at the midpoint [4]

Core Viewpoint - The Law Offices of Frank R. Cruz is investigating potential claims against the board of directors of Inspire Medical Systems, Inc. regarding possible breaches of fiduciary duties to shareholders [1] Group 1 - Inspire Medical Systems disclosed on August 4, 2025, that the launch of its new sleep apnea device, the Inspire V, is facing an "elongated timeframe" due to several issues [1]

Group 1: Company Overview - Boston Scientific specializes in less invasive medical devices that are inserted into the human body through small openings or cuts, with products used in various medical fields including angioplasty, blood clot filtration, and cardiac rhythm management [7] - Approximately 36% of Boston Scientific's total sales come from foreign markets, indicating a significant international presence [7] Group 2: Market Analysis - The current trading volume for Boston Scientific stands at 6,852,637, with the stock price at $92.28, reflecting a neutral RSI indicator status [10] - A consensus target price of $100.0 has been established by market experts, with an analyst from Oppenheimer maintaining an Outperform rating on the stock [9] Group 3: Options Trading Insights - Recent analysis of options trading revealed 21 unusual trades for Boston Scientific, with 47% of traders showing bullish sentiment and 47% bearish [1] - The major market movers are focusing on a price range between $80.0 and $97.0 for Boston Scientific over the last three months [2] - A detailed snapshot of options activity indicates a mix of bullish and bearish trades, with notable call and put options reflecting varying investor sentiments [6]

Core Insights - Inspire Medical Systems (INSP) is positioned for growth due to a significant product transition, with strong clinical traction for Inspire V, clearer reimbursement pathways, and disciplined cost management, despite facing short-term pressures from inventory conversion and competition [1][8]. Company Overview - Inspire Medical focuses on innovative, minimally invasive solutions for obstructive sleep apnea, with a market capitalization of $2.74 billion. The company anticipates a 39.1% earnings decline for Q4 2025 but expects a return to growth in 2026 [3]. Financial Performance - The company has consistently surpassed earnings estimates over the past four quarters, achieving an average surprise of 164.19% [4]. Positive Factors Driving Prospects - The adoption of GLP-1 therapies is increasing patient referrals to sleep clinics, broadening the patient funnel for Inspire Medical [5]. - Operational execution has been solid, with earnings outperformance driven by margin improvement and disciplined expense management, alongside healthy cash flow and share buybacks [6]. - The rollout of Inspire V has reached over 75% of implanting centers, with physician training and contracting nearing completion, indicating strong adoption momentum [9]. - Favorable reimbursement changes, including an 11% increase in physician fees starting January 2026, are expected to enhance the economic viability of Inspire systems [10][11]. Key Challenges - Short-term uncertainty exists due to GLP-1 trialing, which may delay surgical interventions and impact volume growth [12]. - Operating expenses are rising faster than revenues, creating margin pressure, alongside early signs of competitive activity [13]. - Future margin expansion will depend on balancing growth investments with efficiency improvements as revenue growth stabilizes [14]. Estimate Trend - The Zacks Consensus Estimate for Inspire Medical's earnings is $1.60 per share for 2025, with projected revenues of $269 million and a loss per share of 70 cents for Q4 2025 [15].

Abbott’s stock has fallen by over 7% despite reporting strong fiscal year 2025 (FY25) revenues of $44.32bn, representing a 5.7% increase on FY24. The fall of the healthcare giant’s stock primarily appears to be down to its Q4 2025 financials, which were released alongside the FY25 financials ahead of market open on 22 January. For Q4 2025, Abbott achieved revenues of $11.46bn, falling short of analysts’ expectations of $11.80bn, according to London Stock Exchange Group (LSEG) data seen by Reuters. Abbo ...