Article Name Regulatory
CathVision Secures CE Mark for ECGenius System, Expanding Electrophysiology Innovation Across Europe
With CE Mark certification, the AI-powered ECGenius System is now approved for commercialization in the European Economic Area, enhancing real-time electrogram recording and clinical decision-making for healthcare providers.
20th February, 2025
QuantalX Secures CE MDR Approval for Delphi-MD, Paving the Way for EU Commercialization
Breakthrough Neurodiagnostic Device Aims to Transform Early Detection and Treatment of Neurological Disorders Across Europe
18th February, 2025
NX Taiwan Secures TFDA Certification for Medical Device Quality Management—A First for a Japanese Company
Nippon Express (Taiwan) Co., Ltd. earns medical device QMS certification for its NEXT3 warehouse in Taoyuan, reinforcing its capabilities in compliant storage, packaging, and labeling of medical devices to meet Taiwan’s stringent quality control standards.
17th February, 2025
Sanofi’s Merilog Wins FDA Approval as First Rapid-Acting Insulin Biosimilar for Diabetes
The U.S. FDA has approved Merilog (insulin-aspart-szjj), Sanofi’s biosimilar to Novolog, marking a significant step toward expanding access to affordable insulin. The approval strengthens competition in the diabetes treatment market, offering a new rapid-acting insulin option for millions of patients.
17th February, 2025
Navi Medical Secures FDA Clearance for Neonav® Pediatric Vascular Access System
The first-of-its-kind system, designed specifically for neonatal and pediatric patients, leverages real-time ECG signal analysis to improve CVAD placement, enhance patient safety, and reduce complications, marking a major milestone in global pediatric healthcare.
17th February, 2025
Evolus Secures FDA Approval for Evolysse™ Hyaluronic Acid Gels
New Evolysse™ Form and Smooth injectables enhance aesthetic treatment options.
14th February, 2025
PHC and CCRM Partner to Optimize T-Cell Expansion for Advanced Cell Therapies
Collaboration aims to enhance efficiency and improve cell quality in primary T-cell culture processes.
10th February, 2025
Wyss Center Partners with BrainScape Medical to License Groundbreaking Epios® Technology
The collaboration aims to drive long-term brain monitoring and neurostimulation innovations into clinical applications.
06th February, 2025
BD Announces Intent to Separate Biosciences and Diagnostic Solutions Business to Enhance Focus, Drive Growth and Unlock Value
Compelling opportunity expected to unlock substantial value through enhanced focus, tailored investment and capital allocation, and optimized market valuation
06th February, 2025
Womens Wellness brand NUA Raises Rs 35 Crore in Pre-Series C led by Mirabilis Investment Trust
● Round also saw participation from notable investors including Samir Singh, EVP - Asia, Colgate Palmolive & Former Chair of Unilever SE Asia, Shuchi Kothari, Head of DSP Family Office and SRF Limited ● Company turned profitable in Q2 FY24-25 and crossed Rs. 100 Cr net revenue ARR in Q3 ● Company aims to clock Rs. 150 Cr net revenue ARR in the next quarter. ● Funds raised will be deployed for retail expansion and new product introduction across key channels ● Nua, A new age women’s wellness brand offers a wide range of products ranging from toxic-free sanitary pads to period panties, intimate hygiene products, cramp-care solutions, post-partum care and products to manage cyclical acne and more
06th February, 2025
EyeYon Medical expands operations with New Subsidiary in China
The move aims to strengthen EyeYon’s presence in Asia and enhance access to its innovative ophthalmic solutions.
05th February, 2025
FDA approves Roche’s Susvimo as first continuous delivery treatment for Diabetes-Related Blindness
Susvimo becomes the only FDA-approved therapy offering continuous drug delivery for diabetic eye disease.
05th February, 2025
Gyder Surgical secures FDA 510(k) clearance for GYDER® Hip System
World’s first pin-less, image-less solution for precise acetabular cup positioning in anterior hip arthroplasty.
04th February, 2025
Median Technologies' eyonis™ LCS Achieves Primary Endpoint in RELIVE Trial
Successful results from the pivotal study pave the way for regulatory submissions in lung cancer screening.
03rd February, 2025
Intelligent Bio Solutions expands global reach with Drug Screening System upgrade
The enhanced system now supports multiple languages, improving accessibility for global drug screening operations.
03rd February, 2025
QR678® Partners with Spectra Medical to Expand Access Nationwide
The partnership aims to make QR678®'s advanced, non-surgical hair regrowth treatment more accessible across the country through Spectra Medical’s distribution network.
31st January, 2025
Vertex Secures FDA Approval for JOURNAVX™ (suzetrigine), a Novel Non-Opioid Treatment for Acute Pain
JOURNAVX™ introduces a first-in-class approach to managing moderate-to-severe acute pain, offering an alternative to traditional opioid therapies.
31st January, 2025
Ryoncil® commercial launch progress and upcoming product pipeline developments
The latest updates on the market rollout of Ryoncil® and insights into the company’s expanding pipeline of innovative therapies.
31st January, 2025
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