All Blogs
Sep 25, 2025
Medtronic Gains FDA Clearance for Altaviva™ Device to Simplify Treatment of Urge Urinary Incontinence; FDA Grants Breakthrough Device Status to Virtuoso’s Surgical Robot; Lunit and Agilent Strike Partnership to Integrate AI into Biomarker-Based Diagnostics; QuidelOrtho Launches QUICKVUE Influenza + SARS Test for Clinical Use; Transpara® Breast AI Chosen to Power $16M PRISM Clinical Trial in the U.S.; IceCure Showcases ProSense® at CIRSE 2025 with Strong Clinical Evidence from 4 Independent Cryoablation Studies
Medtronic Secured FDA Approval for the Altaviva™ Device, Delivering a Simpler Experience in Treating Urge Urinary Incontinence On September 19, 2025, Medtronic plc, a global leader in healthcare technology, announced that it had received U.S. Food and Drug Administration (FDA) approval for the Altaviva™ de...
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Sep 24, 2025
Smart Inhalers: Redefining Respiratory Care with Technology and Data
The smart inhalers market has been rapidly evolving as digital health and connected medical devices gain traction worldwide. With increasing adoption of telemedicine, remote monitoring, and personalized healthcare, smart inhalers are emerging as a transformative solution for both patients and healthcare providers. ...
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Sep 23, 2025
Merck Wins FDA Approval for KEYTRUDA QLEX for Subcutaneous Use in Adults With Solid Tumors; Incyte Gains FDA Nod for OPZELURA Cream in Children Aged 2–11 With Atopic Dermatitis; Minovia Therapeutics Receives FDA Fast Track Designation for MNV-201 in Myelodysplastic Syndrome; MavriX Bio Secures FDA Fast Track for MVX-220 Gene Therapy in Angelman Syndrome; Biocon Biologics Gets FDA Approval for Denosumab Biosimilars BOSAYA and AUKELSO
FDA Approves Merck’s KEYTRUDA QLEX for Subcutaneous Use Across Multiple Solid Tumors Merck announced that the FDA has approved KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) for subcutaneous administration in adults across most of KEYTRUDA’s approved solid tumor indications. Unlike the intravenous...
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Sep 22, 2025
Sanofi’s WAYRILZ Approval Ushers in New Era for Immune Thrombocytopenia Treatment
Immune thrombocytopenia is a rare autoimmune disorder, affecting both children and adults. The global incidence of ITP is estimated at around 2–5 cases per 100,000 people annually, with prevalence higher in adults and a slight female predominance. In 2024, the total cases of immune thrombocytopenia were approxim...
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Sep 19, 2025
Alcohol Use Disorder: A High-Burden Disease with Untapped Market Promise
Insights around AUD patient burden Over the years, AUD has emerged as a pressing global health challenge, with prevalence steadily rising, particularly in the United States and parts of Europe. This upward trend is fueled by modern lifestyle pressures, work-related stress, anxiety, and shifting social habits, as...
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Sep 18, 2025
Amber Implants Wins FDA 510(k) Clearance for VCFix® Spinal System; Merit Medical’s Embosphere Microspheres Receive CE Mark for Genicular Artery Embolisation in Knee OA; Rejuva Fresh® Introduces REVIVO™ Dual Summit 1927/1550 Fractional Laser System; GE HealthCare Eyes Acquisition of icometrix to Enhance Neurology Imaging and Brain MRI Assessment Tools; Diality Reports First Patient Dosed in Moda-flx Home IDE PRESCRIBE Trial; DUBSTENT DIABETES Trial Begins Enrollment: Aiming to Optimize PCI Outcomes in Patients with Diabetes
Amber Implants Secured FDA 510(k) Clearance for VCFix® Spinal System: A Next-Generation Solution for Vertebral Compression Fractures On September 17, 2025, Amber Implants, a pioneering medical technology company focused on developing advanced solutions for spinal injuries, announced that it received cleara...
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Sep 17, 2025
The Rise of AI-Powered Point-of-Care Diagnostics: Transforming Real-Time Patient Care
Point-of-care (POC) diagnostics have revolutionized healthcare by enabling rapid, on-site testing that delivers actionable results without the delays of traditional laboratory processes. For instance, over 1.5 billion POC tests are performed annually worldwide, ranging from portable blood glucose monitors to point-...
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Sep 16, 2025
Lion TCR Secures Triple FDA Milestones with IND Clearance for Chronic Hepatitis B; Corstasis Therapeutics Wins FDA Approval for ENBUMYST Nasal Spray to Treat Edema in CHF, Liver, and Kidney Disease; Amneal Gains FDA Approval for Sodium Oxybate Oral Solution in Narcolepsy Patients with Cataplexy and Excessive Daytime Sleepiness; Greenwich LifeSciences’ GLSI-100 Granted FDA Fast Track Designation; Akeso’s Ligufalimab Granted FDA Orphan Drug Designation for Acute Myeloid Leukemia
Lion TCR Secures Triple FDA Milestones for Chronic Hepatitis B with IND Clearance of TCR-T Therapy Lion TCR announced that the FDA has cleared its Investigational New Drug (IND) application for LioCyx-M004, authorizing the initiation of phase Ib/II clinical trials in patients with chronic hepatitis B (CHB). The ...
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Sep 15, 2025
The Race for Next-generation Wet AMD Therapies: Shaping the Future of Vision
Neovascular age-related macular degeneration (nAMD or Wet AMD) is a progressive retinal condition and a primary cause of central vision loss among individuals over 60 years old. While it represents only 10–15% of overall AMD cases, it is responsible for nearly 90% of severe vision impairment linked to the disease. ...
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Sep 11, 2025
ONWARD Medical’s ARC-EX System Gains CE Mark; Microbot Medical Secures FDA 510(k) Clearance for LIBERTY® Endovascular Robotic System; Fraiya Launches Major NHS Clinical Trial Using AI for Pregnancy Ultrasounds; Medtronic Hugo™ Robotic-assisted Surgery System in Hernia Repair Met Safety and Effectiveness Endpoints; Willow Launches Willow Wave, Pioneering a New Standard in Breastfeeding; Vivalink Launches New Adhesive to Improve Wearable ECG Performance
ONWARD Medical Received CE Mark for ARC-EX, Enabling Commercial Launch of Breakthrough Spinal Cord Stimulation System in Europe On September 8, 2025, ONWARD Medical N.V., a leading neurotechnology company developing therapies to restore movement, function, and independence for individuals with spinal cord ...
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