All Blogs
May 08, 2025
Teleflex Receives FDA 510(k) Clearance to Expand Use of QuikClot Control+™; Edwards Wins FDA Nod for TAVR Use in Asymptomatic Aortic Stenosis; LivaNova Announces Positive 12-Month Results from OSPREY Study in Moderate to Severe OSA; Lipogems Completes Final Patient Visit in ARISE 1 Knee Osteoarthritis Trial; Roche Launches Advanced Elecsys PRO-C3 Test for More Accurate Liver Fibrosis Grading; iRhythm Introduces Zio® Long-Term ECG Monitoring in Japan, Enhancing AI-Driven Arrhythmia Detection
Teleflex Secures FDA 510(k) Clearance for Broader Use of QuikClot Control+™ Hemostatic Device On April 30, 2025, Teleflex Incorporated, a global leader in medical technologies, announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the expanded Indications for Use ...
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May 07, 2025
Artificial Intelligence and Machine Learning in Software as a Medical Device (SaMD)
Artificial Intelligence (AI) and Machine Learning (ML) are reshaping the world of Software as a Medical Device (SaMD), bringing a new level of intelligence and efficiency to healthcare. SaMD refers to software designed for medical purposes that doesn’t rely on physical hardware. When integrated with AI/ML, these so...
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May 06, 2025
Abeona Secures FDA Nod for ZEVASKYN, the First Gene Therapy for RDEB; AbbVie Gains FDA Approval for RINVOQ in Giant Cell Arteritis; Lantern Pharma Advances LP-184 with IND Clearance for TNBC Trial; Ichnos Glenmark Earns FDA Fast Track for ISB 2001 in Multiple Myeloma; Rezolute Wins Breakthrough Therapy Designation for Ersodetug in Tumor-Induced Hypoglycemia
FDA Approves Abeona’s ZEVASKYN as First Cell-Based Gene Therapy for RDEB The FDA approved Abeona Therapeutics’ ZEVASKYN (prademagene zamikeracel, or pz-cel), the first and only autologous cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB). ZEVASKYN is d...
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May 05, 2025
Emerging Lupus Nephritis Therapies: Addressing Unmet Needs through Innovation and Mechanistic Targeting
Lupus nephritis is a serious and common complication of systemic lupus erythematosus (SLE), characterized by inflammation of the kidneys that can lead to progressive organ damage and increased mortality. Approximately one-third of adults with SLE present with lupus nephritis at diagnosis, and up to half will develo...
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May 02, 2025
New Era in Niemann-Pick Disease: A Comparative Review of MIPLYFFA and AQNEURSA
Niemann-Pick disease type C (NPC) is a rare, aggressive, and life-threatening neurovisceral disorder with a profound impact on both patients and the healthcare system. Caused by mutations in the NPC1 or NPC2 genes, NPC disrupts intracellular lipid transport, leading to toxic accumulation of cholesterol and other li...
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May 01, 2025
Medtronic Receives FDA Approval for OmniaSecure™ Lumenless Defibrillation Lead and Presents Positive Clinical Trial Results for Hugo™ Robotic-Assisted Surgery System; Roche’s AI Companion Diagnostic for NSCLC Earns FDA Breakthrough Device Designation; Boston Scientific Announces Positive 12-Month Phase 2 Results from ADVANTAGE AF Trial of FARAPULSE™ PFA System; Bausch Health Launches Fraxel FTX™ to Advance Skin Rejuvenation Treatments; Gestalt Diagnostics Secures $7.5M in Series A to Scale AI Pathology Solutions
Medtronic Received FDA Approval for Smallest-Diameter, Lumenless Defibrillation Lead, the Omniasecure™ Lead and Published Investigational Clinical Study Results, Offering New Therapy Option for Heart Rhythm Disorders On April 25, 2025, Medtronic plc., a global leader in healthcare technology, received U.S....
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Apr 30, 2025
Navigating U.S. Tariffs in 2025: Impacts and Strategies for Pharma and Healthcare
In 2025, the United States launched a bold new wave of tariffs, targeting imports critical to the pharmaceutical and healthcare industries. These policies, driven by a push to strengthen domestic manufacturing, impose a 10% tariff on all imported goods, alongside steeper levies of up to 245% on Chinese active pharm...
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Apr 29, 2025
Boston Scientific Pushes Forward Despite $200M Tariff Challenge; Northstrive Biosciences Gets FDA Green Light to Advance EL-22 Obesity Trial; Roche Acts Swiftly to Offset U.S. Tariff Impact with Global Engagements; Verastem Oncology Secures IND Clearance for KRAS G12D Inhibitor Trial; BlackfinBio Gets FDA OK for Phase I/II Trial of BFB-101 in SPG47
Boston Scientific Pushes Forward Despite $200M Tariff Challenge Boston Scientific has announced that tariffs are expected to add approximately $200 million to its costs this year, but the company remains confident in its ability to absorb the financial hit. Despite the tariff burden, the company reported robust ...
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Apr 28, 2025
European Lung Cancer Congress (ELCC) 2025 Recap: Advances in Lung Cancer Research and Treatment
The European Lung Cancer Congress (ELCC) 2025, which took place in Paris from March 26-29, 2025, brought together lung cancer experts who presented the most anticipated clinical results. The three days served as an essential platform for exchanging valuable insights and fostering connections within the lung cancer ...
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Apr 25, 2025
Late-Breaking Science at AAN 2025: Shaping the Future of Neurology
The 77th Annual Meeting of the American Academy of Neurology (AAN 2025), held from April 5–9 in San Diego and online, served as a pivotal forum for advancing research in neurology, with particular relevance to neurodegenerative diseases. As one of the largest gatherings of neurologists globally, the conference prov...
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