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KORU Medical Submits FDA 510k For FreedomEDGE Use With PHESGO In HER2 Positive Breast Cancer

KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on t...

January 01, 2026 | News

StimLabs Secures FDA 510k Clearance For Theracor Advancing Wound Care Innovation

StimLabs announces that the U.S. Food & Drug Administration (FDA) has granted 510(k) clearance for Theracor, the first human umbilical cord-derived med...

December 31, 2025 | News

Medtronic Files For MiniMed IPO As Diabetes Business Prepares For Public Market Separation

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, announced that its Diabetes business, which as previously announced will operate under...

December 29, 2025 | News

Abbott Secures FDA Approval For Volt PFA System, Advancing Atrial Fibrillation Treatment In The United States

Abbott's Volt™ PFA System, the latest generation of cardiac ablation technology, is designed for people battling heart rhythm d...

December 29, 2025 | News

Galaxy Therapeutics Completes Enrollment In Landmark U.S. IDE Trial For Brain Aneurysm Device

Galaxy Therapeutics, a privately held, clinical-stage medical device company focused on treating brain aneurysms, announced it has successfully completed e...

December 26, 2025 | News

Mondego Bio Selects ZE00 0388 As Lead Clinical Candidate And Prepares For Phase One Entry In 2026

Mondego Bio, a clinical-stage biotechnology company developing next-generation small-molecule immuno-oncology therapies, today announced the formal selecti...

December 25, 2025 | News

Enveda Advances Third Asset Into The Clinic As FDA Clears IND For ENV 6946 In Inflammatory Bowel Disease

Enveda achieves a significant milestone with three assets now in clinical development, further validating its platform’s ability to deliver differe...

December 25, 2025 | News

Solventum Completes Acquisition Of Acera Surgical To Strengthen MedSurg And Wound Care Portfolio

Expands MedSurg portfolio into the fast-growing synthetic tissue matrices technology space in acute care settings in the U.S. Accelerates Solventum's bu...

December 24, 2025 | News

Promontory Therapeutics Exceeds Interim Efficacy Bar In Thymoma Study With PT 112

Three of the first 10 patients with thymoma evaluated by RECIST have partial responses. Findings exceed protocol requirement of two re...

December 24, 2025 | News

NeuroSense Reports Clean Safety Profile From Phase 2 PrimeC Study In Alzheimer’s Disease

NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for&nbs...

December 24, 2025 | News

Samsung Biologics Acquires GSK Rockville Facility To Establish First US Manufacturing Site

- Secures the company’s first U.S.-based manufacturing site, strengthening and diversifying its global supply network - Additional investments plann...

December 22, 2025 | News

Soin Neuroscience And BIOTRONIK Neuro Advance Personalised Spinal Cord Stimulation Research

Soin Neuroscience and BIOTRONIK Neuro announced a research collaboration to advance personalized spinal cord stimulation (SCS) tuning using Soin Neuroscien...

December 22, 2025 | News

Atom Therapeutics Secures FDA Approval To Advance Phase II Trial Of ABP 745 In Atherosclerosis

Atom Therapeutics, a clinical stage biotechnology company developing best-in-class treatments for inflammatory and metabolic diseases, today announced FDA ...

December 18, 2025 | News

Sanofi And Dren Bio Expand Strategic Collaboration To Advance Next Generation B Cell Depleting Therapies In Autoimmune Disease

– New collaboration builds on Sanofi’s prior acquisition of DR-0201 and further leverages Dren Bio’s proprietary Targeted Myeloid Engag...

December 17, 2025 | News

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