Article Name Regulatory
Hesperos Unveils First Digital Twin of Human Disease with Organ-on-a-Chip Breakthrough
Landmark integration of in vitro organ-on-a-chip and computational modeling marks a pivotal advancement in disease simulation, drug testing, and personalized medicine.
23rd July, 2025
Canada Grants Patent to bioAffinity Technologies for CyPath® Lung Diagnostic Test
New patent strengthens global IP portfolio for noninvasive lung cancer detection platform, expanding bioAffinity’s reach into international markets
23rd July, 2025
Autonomix Medical Secures New U.S. Patent for Advancing Nerve-Targeted, Minimally Invasive Therapies
Patent strengthens company’s IP portfolio as it expands innovative treatments for chronic pain, oncology, and other high-need conditions
22nd July, 2025
Takeda Secures FDA 510(k) Clearance for HyHub™ and HyHub™ Duo Devices
New devices designed to streamline and personalize HYQVIA® administration for patients receiving subcutaneous immune globulin therapy
22nd July, 2025
Medtronic Earns CE Mark for Expanded Use of MiniMed™ 780G Insulin Pump System
Approval now includes children as young as two, pregnant individuals, and people with type 2 diabetes across Europe
22nd July, 2025
Spirair Secures FDA Clearance for TurbAlign™ Bioabsorbable Nasal Implant
Innovative device designed to maintain sinus patency post-surgery, enhancing healing and patient comfort without the need for removal
22nd July, 2025
Johnson & Johnson’s TAR-200 for Bladder Cancer Granted FDA Priority Review
NDA for TAR-200 targets high-risk non-muscle invasive bladder cancer, highlighting potential to transform treatment for patients unresponsive to BCG therapy
21st July, 2025
Texas Cardiac Arrhythmia Institute Becomes First in U.S. to Use FDA-Approved Wireless System for Arrhythmia Treatment
St. David's Medical Center pioneers clinical use of innovative wireless EP solution, marking a new chapter in minimally invasive cardiac care.
21st July, 2025
ZEISS CLARUS 700 Gains Regulatory Nod in China, Expanding Ophthalmic Portfolio
The NMPA approval of the ZEISS CLARUS 700 represents a major leap forward in ultra-widefield retinal imaging, offering high-resolution, true color visualization to support early detection and management of complex eye diseases across China.
21st July, 2025
Fulgent Genetics Secures EU CE Mark for FulgentExome and FulgentPLM
Certification Advances Global Access to Comprehensive Genetic Testing and Precision Medicine Solutions in Europe
18th July, 2025
UroMems Secures FDA and ANSM Clearance to Begin Pivotal Study of UroActive® Smart Implant for Male SUI
Landmark trial to evaluate world’s first autonomous, electronic artificial urinary sphincter for stress urinary incontinence in men
18th July, 2025
Medtronic Secures CE Mark for LigaSure™ Integration on Hugo™ Robotic System, Advancing the Future of Surgery
The regulatory milestone enables the use of Medtronic’s trusted vessel sealing technology on its Hugo™ robotic-assisted surgery platform, enhancing precision and expanding clinical versatility across Europe.
16th July, 2025
HistoSonics Secures Expanded Insurance Coverage for Liver Tumor Therapy
Non-Invasive Histotripsy Treatment Now Accessible to 7 Million Blue Cross Blue Shield Highmark Members Across U.S.
15th July, 2025
Zimmer Biomet to Acquire Monogram Technologies in Strategic Move to Enhance Robotic Surgery Portfolio
Definitive agreement strengthens Zimmer Biomet’s position in orthopedic innovation by integrating autonomous robotic technology into its surgical solutions suite.
14th July, 2025
Medtronic Responds to CMS Proposed National Coverage Determination for Symplicity Spyral™ RDN System
Company Welcomes Milestone Toward Expanding Medicare Access to Innovative Renal Denervation Therapy for Uncontrolled Hypertension
14th July, 2025
AirLife and Vyaire Recall Infant Ventilation Circuits Over Life-Threatening Disconnection Risk
FDA issues Class I recall for AirLife Infant Heated Wire Circuits following reports of adapter disconnections that could lead to hypoxia or respiratory failure in neonatal patients.
14th July, 2025
FDA Lists 200+ Sensor-Based Digital Health Devices Cleared Between 2014–2025, Redefining Remote Patient Monitoring
From smartwatches to continuous glucose monitors, the growing FDA list highlights how wearable sDHTs are transforming healthcare beyond the clinic into homes and everyday life
14th July, 2025
FDA Lists 90+ AR/VR Medical Devices Approved Between 2015–2025, Cementing a Decade of Immersive Tech in Clinical Care
With dozens of approved devices across neurology, orthopaedics, and radiology, the FDA underscores its commitment to guiding safe, innovative integration of augmented and virtual reality in healthcare
14th July, 2025
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