- Wysa Partners with RxCap to Advance Medication Adherence
- ACIP Recommends Use of Merck’s ENFLONSIA for Prevention of Respiratory Syncytial Virus Lower Respiratory Tract Disease in Infants Younger than 8 Months of Age Born During or Entering Their First RSV Season
- Liviniti Achieves HITRUST i1 Certification for Industry-leading Security Practices
- STAAR Surgical Announces Appointment of Deborah Andrews as CFO | Forms Capital Stewardship Committee of the Board of Directors
- Breakthrough in Patient-Derived Stem Cells for Therapeutic Regenerative Medicine
Medical Device News Magazine
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"Medical Device and Biotechnology Sector News: Essential Key Insights and Noteworthy Developments that are Shaping the Future"
InspireMD Announces CE Mark Approval for CGuard ® Prime Embolic Prevention System (EPS) Under European MDR for the Prevention of Stroke
CGuard® Prime was developed incorporating extensive user feedback and optimizes deliverability and deployment of the proven CGuard stent.
Nectero Medical Secures Category III CPT Codes for Investigational Therapy to Treat Small- to Medium-Sized AAAs
This designation represents a key milestone toward future reimbursement and broader clinical adoption.
Medtronic Announces MiniMed as Name for Planned New Diabetes Company
The name honors the company’s roots, reflecting its original name prior to its acquisition by Medtronic in 2001, and a deep 40-year history of being at the forefront of transforming diabetes care around the world.
Project Uses AI to Develop an Innovative System for Diagnosing and Rehabilitating Joint Conditions
This tool offers comprehensive monitoring of musculoskeletal disease progression in each patient, enabling more effective medical and rehabilitation interventions while reducing economic impact. The KINESSENSOR project, funded by IVACE+i and the ERDF, facilitates personalized treatments, thereby improving their effectiveness.
Innovative Solutions for Today's Challenges, Secured Funding for a Brighter Future
Materna Medical Announces Ellora™ and Additional Close on $20M Series B2
The round welcomed new funds GLIN Impact Capital, Wealthing VC Club, and Citrine Angels, and was led by InnovaHealth Partners and other key existing investors.
Glytec Secures $36 Million Growth Investment to Accelerate AI-Powered Diabetes Technology Platform Innovation
This significant funding will fuel the continued expansion of Glytec’s platform, including its flagship Glucommander® SaaS solution, accelerate the development of innovative new technologies to address the growing global health crisis of diabetes and related co-morbidities, and support the continued rapid response to upcoming CMS quality measures that will hold health systems accountable for inpatient glycemic control.
Alithea Genomics Launches MERCURIUS™ Total DRUG-seq: A Next-Generation Full-Length Transcriptome Profiling Platform for High-Throughput Compound Screening and Target Validation
“MERCURIUS™ Total DRUG-seq represents a new frontier in transcriptome-scale compound screening,” said Riccardo Dainese, CEO and Co-founder of Alithea Genomics. “We are empowering scientists to capture the full complexity of transcriptional responses—at a massive scale and with minimal cost. This product opens the door to discovering new biology, new targets, and new drugs faster than ever before.”
1Elevan Biopharmaceuticals Announces the Development of Its Next-Generation Peptide Therapeutics Headquarters in Fishers, Indiana
The new 133,500-square-foot headquarters at 12001 Exit 5 Parkway will house an advanced pharmacy featuring category III, 503A/503B compounding capabilities alongside integrated telemedicine services for peptide therapy management and prescription fulfillment.
Comprehensive Insights into Medical Device and Biotechnology Company Mergers and Acquisitions Trends and Strategies
Poseida Therapeutics Announces Agreement to be Acquired by Roche Holdings, Inc.
The proposed acquisition will establish a new core capability for Roche in allogeneic cell therapy, with lead opportunities focused on CAR-T programs covered by the existing strategic collaboration between Poseida and Roche in hematologic malignancies. It will include CAR-T programs for solid tumors and autoimmune diseases, along with Poseida’s genetic engineering platform and related preclinical medicines.
Boston Scientific Closes Acquisition of Axonics
Meghan Scanlon, senior vice president and president, Urology, Boston Scientific. “By closing this acquisition, we’re pleased to welcome the Axonics team into Boston Scientific. The addition of the Axonics product portfolio enables us to expand into sacral neuromodulation, a high-growth adjacency for our Urology business, while bringing a comprehensive portfolio of products to patients around the world who are seeking tailored treatment options based on their life stage and incontinence severity.”
FDA Medical Device Updates
Neuspera Medical Receives FDA Approval for First Integrated Sacral Neuromodulation (iSNM) System for Urinary Urge Incontinence
Neuspera’s iSNM system offers patients with UUI an alternative to traditional SNM. UUI is a major component of overactive bladder, a condition that affects approximately 1 in 5 women in the U.S. UUI has a major impact on quality of life, driving the demand for more effective and patient-friendly treatment options.
TYBR Health Announces FDA 510(k) Clearance for B3 GEL™ System
A flowable bio-gel to protect healing tissue and preserve function.
Non-Profit Organization News and Updates
Medical Imaging Technologies and Their Impact on Modern Healthcare
Healing Headlines, Transforming Lives: Hospitals in the News
CT Colonography Beats Stool DNA Testing for Colon Cancer Screening
“Among the safe, minimally invasive colorectal cancer screening options, CT colonography is more effective at preventing and detecting cancer—and is also more cost-effective—than stool DNA testing,” Dr. Pickhardt said. “Furthermore, CT colonography can provide for extracolonic screening for things like osteoporosis and cardiovascular disease.”
Carotid Plaque May Pose Danger Over Time
Data from the Rotterdam Study in the Netherlands.
Hyperfine Announces FDA Clearance of Optive AI™ Software, Introducing the Most Substantial Image Quality Improvement Ever for the Swoop® System
Latest Swoop® System software delivers a substantial leap in image quality for AI-powered portable MR brain imaging.
Delray Medical Center Acquires Intuitive da Vinci 5 Surgical System
Da Vinci 5 is the newest entry to the da Vinci portfolio of systems, which also includes da Vinci X®, da Vinci Xi®, and da Vinci SP®. The system can be used for minimally invasive surgical procedures for urology, gynecology, thoracic, and general surgeries.
Adventist HealthCare Emergency Departments Launch AI Initiative to Help Enhance Patient Safety and Care Efficiency
The software, KATE AI, is helping care teams ensure the safety and consistency of triage at Adventist HealthCare Shady Grove Medical Center, Adventist HealthCare White Oak Medical Center and Adventist HealthCare Fort Washington Medical Center. Emergency teams at the hospitals are using KATE AI to help verify care plans for patients who are at higher risk or have more complex conditions.
Medical Device and Biotechnology Executives: Innovative Professionals on the Move and Making Waves in the Industry
Clinilabs Expands Executive Leadership Team With Key Appointments
Clinilabs, LLC, a leading full-service contract research organization (CRO) specializing in central nervous system (CNS) drug and medical technology development, today announced the appointments of
Rad AI Names Demetri Giannikopoulos as Chief Growth Officer to Accelerate AI-Driven Radiology Healthcare Growth
Mr. Demetri brings over 20 years of experience in healthcare technology, with a track record of advancing AI adoption in complex clinical settings.
RapidRatings Appoints Charlie Minutella as CEO to Accelerate Strategic Growth and Innovation
Charlie Minutella brings a wealth of industry knowledge and a strong track record of leadership, innovation, and operational excellence. His appointment ushers in a new chapter for RapidRatings as it continues to shape the future of financial risk intelligence.
Dr Ray Kotwicki, Chief Medical Officer of Hightop Health, Appointed President of the Southern Psychiatric Association
Dr Ray Kotwicki will lead the SPA into its next chapter, focusing on education, collaboration, and advocacy for psychiatrists across the region.