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Study showed MiniMed™ 780G system achieved ADA-recommended time-in-range goals even on days users forgot to bolus
Prnewswire· 2026-01-07 14:05
Core Insights - A new retrospective analysis published in Diabetes Care indicates that users of the MiniMed™ 780G system can achieve American Diabetes Association (ADA) recommended goals for time-in-range (TIR) even on days when mealtime boluses are missed, with a reported TIR of 76.3% on such days when using SmartGuard™ technology with optimal settings [1][4][6] Group 1: Study Findings - The study analyzed real-world CareLink™ user data from 369,467 individuals using the MiniMed™ 780G insulin pump, focusing on 54,553 users who experienced at least 10 days without bolusing between January 2, 2020, and March 31, 2025 [4] - Users employing recommended optimal settings achieved a TIR of 76.3%, compared to 69.3% for those using non-recommended settings, with a mean sensor glucose of 149 mg/dL versus 160 mg/dL [6] - More than 61% of users with recommended optimal settings met all three ADA recommended glycemic targets on missed bolus days, compared to 36.6% of users with other settings [6] Group 2: Implications for Diabetes Management - The findings underscore the advanced capabilities of the MiniMed™ 780G system, which adjusts insulin delivery every five minutes based on sensor readings, providing support when boluses are missed or carbohydrates are underestimated [3][4] - The study highlights the importance of optimized settings in diabetes management, particularly for users who may occasionally miss boluses, thereby reducing the overall burden of diabetes care [2][4] Group 3: Company Overview - Medtronic Diabetes aims to make diabetes management more predictable through advanced technology, including next-generation sensors and intelligent dosing systems [8] - The company has been a pioneer in diabetes technology for over 40 years, focusing on customer experience and innovative solutions to improve health outcomes [9]
ITGR STOCK NEWS: A Class Action Was Filed on Behalf of Integer Holdings Corporation Shareholders for Securities Fraud, Contact BFA Law by February 9 Deadline
TMX Newsfile· 2026-01-07 13:46
Core Viewpoint - A class action lawsuit has been filed against Integer Holdings Corporation and its senior executives for securities fraud following a significant drop in stock price due to alleged violations of federal securities laws [1][3]. Group 1: Lawsuit Details - The lawsuit is pending in the U.S. District Court for the Southern District of New York, titled West Palm Beach Firefighters' Pension Fund v. Integer Holdings Corporation, et al., No. 1:25-cv-10251 [3]. - Investors have until February 9, 2026, to request to be appointed to lead the case [3]. Group 2: Company Performance and Allegations - Integer designs and manufactures cardiac rhythm management and cardiovascular products, including electrophysiology devices [4]. - The company allegedly overstated demand for its EP devices while public assurances contradicted the reality of falling demand and revenue [5]. - On October 23, 2025, Integer lowered its 2025 sales guidance to between $1.840 billion and $1.854 billion, down from a previous range of $1.850 billion to $1.876 billion, which was below analysts' expectations [6]. Group 3: Stock Impact - Following the announcement of lowered sales guidance, Integer's stock price dropped by $35.22 per share, or over 32%, from $109.11 on October 22, 2025, to $73.89 on October 23, 2025 [6].
Baird Medical Secures Regulatory Approvals in Pakistan and Vietnam
Prnewswire· 2026-01-07 13:30
Core Insights - The company has successfully launched its product in Pakistan at the Armed Forces Institute of Radiology & Imaging, guided by Dr. Raza Raheem, a key figure in interventional radiology [1] - The registration approval in Vietnam signifies a major expansion of Baird Medical's presence in the Southeast Asian market, highlighting the company's commitment to global commercialization [2][3] Company Overview - Baird Medical specializes in minimally invasive diagnostics and treatment, focusing on surgical robotic systems and innovative surgical instruments [3] - The company aims to enhance patient outcomes through precision technology and advanced diagnostic solutions, and plans to collaborate with leading academic institutions [3] - Baird Medical is FDA 510(k)-certified and its solutions are utilized in over 30 prestigious hospitals in the U.S., including Mayo Clinic and UCSF Medical Center [3] - The company is a market leader in China for thyroid microwave ablation devices and is expanding its commercial presence in over 20 countries [3]
Sofwave Medical Reports Preliminary, Unaudited, Fourth Quarter and Full Fiscal Year 2025 Topline Financial Results
Globenewswire· 2026-01-07 13:30
Core Insights - Sofwave Medical Ltd announced preliminary financial results for Q4 and the full fiscal year ending December 31, 2025, indicating significant revenue growth [1][7]. Financial Performance - Q4 2025 revenue is projected to be between $28.6 million and $28.9 million, representing an increase of approximately 57% compared to Q4 2024, which had revenue of about $18.3 million [7]. - Full fiscal year 2025 revenue is expected to be between $87.3 million and $87.6 million, reflecting a 46% increase from approximately $59.7 million in the previous fiscal year [7]. - As of December 31, 2025, cash and cash equivalents, including a short-term restricted deposit, are expected to be $35.2 million, up from $26.5 million as of September 30, 2025 [7]. Strategic Developments - The Board of Directors approved management to prepare and submit a draft Form F-1 Registration Statement to the U.S. Securities and Exchange Commission (SEC) for a potential public offering in the United States [3].
Integer Holdings Corporation (ITGR) Lowered Sales Outlook Triggers Securities Fraud Class Action – Contact BFA Law before February 9 Court Deadline
Globenewswire· 2026-01-07 13:15
Core Viewpoint - A class action lawsuit has been filed against Integer Holdings Corporation and its senior executives for securities fraud following a significant drop in stock price due to alleged violations of federal securities laws [1]. Group 1: Lawsuit Details - The lawsuit is pending in the U.S. District Court for the Southern District of New York, titled West Palm Beach Firefighters' Pension Fund v. Integer Holdings Corporation, et al., No. 1:25-cv-10251 [3]. - Investors have until February 9, 2026, to request to be appointed to lead the case [3]. Group 2: Company Background - Integer Holdings Corporation designs and manufactures cardiac rhythm management and cardiovascular products, including electrophysiology devices that diagnose and treat arrhythmias [4]. - The company had previously claimed strong sales growth and market position for its electrophysiology devices, which is now being challenged [4]. Group 3: Financial Performance - Integer's stock price dropped by $35.22 per share, or over 32%, from $109.11 on October 22, 2025, to $73.89 on October 23, 2025, following the announcement of lowered sales guidance [6]. - The company revised its 2025 sales guidance to a range of $1.840 billion to $1.854 billion, down from $1.850 billion to $1.876 billion, which was below analysts' expectations [6]. - Integer also projected poor net sales growth of -2% to 2% and organic sales growth of 0% to 4% for 2026, citing slower adoption of two of its electrophysiology devices [6][5].
SeaStar Medical Announces 2026 Milestones
Globenewswire· 2026-01-07 13:13
Core Insights - SeaStar Medical is focused on expanding the adoption of its QUELIMMUNE therapy for ultra-rare pediatric acute kidney injury (AKI) and advancing its Selective Cytopheretic Device (SCD) therapy for adult AKI, targeting a potential market of $4.5 billion [1][2] Group 1: QUELIMMUNE Therapy - The QUELIMMUNE therapy is designed for children with AKI and sepsis, approved under a Humanitarian Device Exemption, requiring participation in the SAVE Surveillance Registry [3] - Clinical studies show a 77% survival rate for patients treated with QUELIMMUNE, indicating a 50% reduction in loss of life compared to historical data [4] - The customer base for QUELIMMUNE has expanded to 10 top-rated children's hospitals, with expectations of achieving approximately $2 million in net product revenue in 2026 [8] Group 2: SCD Therapy Development - The SCD therapy is being advanced for adult AKI through the NEUTRALIZE-AKI pivotal trial, with enrollment completion expected by the end of 2026 [2][6] - The FDA has granted Breakthrough Device Designation for the SCD therapy in both adult AKI and acute chronic heart failure (CHF) with cardiorenal syndrome, facilitating a faster approval process [2][10] - The company is exploring broader applications of the SCD therapy, including its use in patients with CHF awaiting left ventricular assist device (LVAD) implantation [2][10] Group 3: Market Opportunities - The potential market for the SCD therapy in adult patients with AKI and CHF is described as a multi-billion-dollar opportunity in the U.S. alone [2] - The company aims to leverage rapid regulatory pathways to commercialize the SCD therapy across various hyperinflammatory conditions [2][10] - The successful outcome of the NEUTRALIZE-AKI trial could lead to a Premarket Approval application in 2027, with expectations for rapid approval and early adoption [2]
Inspire Medical Systems, Inc. to Report Fourth Quarter and Full Year 2025 Financial Results on February 11, 2026
Globenewswire· 2026-01-07 13:00
MINNEAPOLIS, Jan. 07, 2026 (GLOBE NEWSWIRE) -- Inspire Medical Systems, Inc. (NYSE: INSP) (Inspire) will release financial results for the fourth quarter and full year 2025 after the close of trading on Wednesday, February 11. Inspire’s management team will host a corresponding conference call beginning at 5:00 p.m. Eastern Time to discuss the financial results and recent business developments. A webcast of the call will be accessible via the Investor Relations page of the Inspire website or through this li ...
Picard Medical Announces Conference Participation During J.P. Morgan Healthcare Conference Week
Globenewswire· 2026-01-07 13:00
Core Viewpoint - Picard Medical, Inc. is actively participating in key healthcare conferences, highlighting its leadership in total artificial heart technology and its commitment to advancing medical innovation [1][4]. Group 1: Conference Participation - Picard Medical will attend the 44th Annual J.P. Morgan Healthcare Conference, including events such as LifeSci Advisors' Corporate Access Event and Lifeblood and Goodwin's CEO-Only MedTech Forum [1]. - The Lifeblood and Goodwin's MedTech CEO-Only Forum is scheduled for January 12, 2026, as an invite-only discussion forum in San Francisco, CA [3]. - The LifeSci Advisors 15th Annual Corporate Access Event will take place on January 14, 2026, featuring one-on-one meetings at The Beacon Grand, San Francisco, CA [3]. Group 2: Company Overview - Picard Medical, Inc. is the parent company of SynCardia Systems, LLC, which is recognized for its SynCardia Total Artificial Heart (STAH), the only commercially available total artificial heart technology for patients with end-stage heart failure [4]. - The SynCardia Total Artificial Heart is the first artificial heart approved by both the FDA and Health Canada, and it is the only commercially available artificial heart in the United States and Canada [4]. - Over 2,100 implants of the SynCardia Total Artificial Heart have been performed in hospitals across 27 countries, making it the most widely used and extensively studied artificial heart globally [4].
Why Did SI-Bone (SIBN) Surge Spike After Hours? - Canaccord Genuity Group (OTC:CCORF), Morgan Stanley (NYSE:MS)
Benzinga· 2026-01-07 06:53
Core Insights - SI-Bone Inc. (NASDAQ:SIBN) shares experienced a 3.65% increase in after-hours trading, closing at $21.14, following a regular trading session close of $20.40, which was up 2.15% [1] Executive Share Sales - Three executives sold shares to cover tax obligations from restricted stock unit vesting, with Chief Financial Officer Anshul Maheshwari selling 5,229 shares for a total of $102,710.61 [2] - Senior Vice President and Chief Legal Officer Michael Pisetsky sold 3,460 shares totaling $67,896.05, while President of Commercial Operations Anthony Recupero sold 3,677 shares for $72,143.84 [3] Trading Metrics and Performance - SI-Bone has a Relative Strength Index (RSI) of 62.48 and a 12-month return of 44.48%, indicating strong performance and an upward trend [5] - The company's market capitalization is approximately $885.2 million, with shares trading between a 52-week high of $21.06 and a low of $12.50 [5] - Currently, SIBN is trading at 92.2% of its 52-week range, suggesting it is near its annual highs [6] Analyst Ratings - Analysts from Truist Securities, Canaccord Genuity, Needham & Company, and Morgan Stanley have maintained bullish ratings and raised price targets for SIBN [6] - Benzinga's Edge Stock Rankings indicate a positive price trend for SIBN across all time frames [7]
威高股份-WEGO 交易预案更新:我们的解读与后续步骤
2026-01-07 03:05
Summary of Shandong Weigao Conference Call Company Overview - **Company**: Shandong Weigao (Ticker: 1066.HK) - **Industry**: China Healthcare - **Market Position**: - WEGO Prefills holds over 50% market share in pharma packaging in China, serving 700-800 domestic and 200+ international biopharma clients [2] - Weigao Blood Purification is the leading player in blood purification in China with over 30% market share, primarily serving hospitals' hemodialysis departments [2] Key Points Strategic Developments - **Synergies**: Post-integration of WEGO Prefills and Weigao Blood, the latter can leverage its filtration technology to develop upstream solutions for biopharma clients, targeting a Rmb21 billion market in China [2] - **Growth Strategy**: Weigao plans to enhance investment in perioperative and interventional device sectors, utilizing cash flow from its consumable business and considering M&A opportunities [3][8] Financial Outlook - **2025 Earnings Preview**: Expected low single-digit revenue growth and a slight decline in net profit, attributed to negative foreign exchange impacts [3] - **Valuation**: The deal valuation of Rmb8.5 billion suggests a profit multiple of 14.7x for 2024 and 13.3x for 2026, with a high single-digit organic CAGR for WEGO Prefills considered fair [8] Market Performance - **Stock Rating**: Equal-weight with a price target of HK$6.20, indicating a 19% upside from the current price of HK$5.23 [5] - **Market Capitalization**: Approximately HK$23.65 billion with an average daily trading value of HK$72 million [5] Risks and Considerations - **Upside Risks**: Better-than-expected core business performance, favorable government policies, successful product rollouts, and accretive M&A [13] - **Downside Risks**: Regulatory challenges, intense competition affecting growth and margins, and potential underperformance in orthopedics and interventional devices [13] Additional Insights - **Integration Impact**: The integration of WEGO Prefills and Weigao Blood is subject to minority shareholder approval and regulatory approvals, with Weigao expected to hold a 52.1% stake post-deal [8] - **Financial Metrics**: Projected EPS growth from Rmb0.45 in 2024 to Rmb0.49 in 2027, with revenue expected to rise from Rmb13.09 billion in 2024 to Rmb15.73 billion in 2027 [5] This summary encapsulates the strategic direction, financial outlook, and market positioning of Shandong Weigao, highlighting potential investment opportunities and risks within the healthcare sector in China.