MedTech Spectrum

Article Name Regulatory

Medtronic Secures FDA Approval for BrainSense™ Adaptive DBS, Pioneering Largest BCI-Enabled Therapy Launch

New real-time, self-adjusting deep brain stimulation system transforms Parkinson’s care with personalized neuromodulation

25th February, 2025

Japan Approves Sarclisa-VRd for Newly Diagnosed Multiple Myeloma Patients

Regulatory green light follows IMROZ Phase 3 study results showing significant progression-free survival benefit

25th February, 2025

CathVision Secures CE Mark for ECGenius System, Expanding Electrophysiology Solutions Across Europe

With CE Mark approval, CathVision’s AI-powered ECGenius System is set to launch in the European market, enhancing real-time electrogram recording and clinical decision-making for healthcare providers.

25th February, 2025

EMA Approves Takeda’s TAKHZYRO Pre-Filled Pen for Subcutaneous Administration in Adolescent and Adult HAE Patients

The new 2 mL pre-filled pen option expands individualized treatment choices for hereditary angioedema (HAE) patients, reinforcing Takeda’s commitment to reducing disease burden and improving quality of life.

25th February, 2025

IceCure Medical Seeks Israeli Regulatory Approval for Next-Gen XSense™ Cryoablation System

Building on FDA clearance, IceCure files for Israeli approval of its XSense™ System, expanding minimally invasive cryoablation solutions across multiple medical specialties in line with the growing trend of surgical de-escalation.

25th February, 2025

Co-Diagnostics Withdraws 510(k) Submission for COVID-19 Test to Pursue Enhanced Version

Following constructive discussions with the FDA, Co-Dx shifts focus to an improved test submission, incorporating platform advancements and optimizing long-term performance.

24th February, 2025

South Korea’s PranaQ Secures FDA Clearance for AI-Powered Sleep Apnea Wearable, Backed by NAVER D2SF

With FDA 510(k) clearance for TipTraQ, PranaQ is set to transform home-based sleep diagnostics. The AI-driven wearable, supported by NAVER D2SF, delivers clinical-grade sleep and respiratory insights, ensuring accessible, multi-night testing and seamless remote monitoring. With FDA 510(k) clearance for TipTraQ, PranaQ is set to transform home-based sleep diagnostics. The AI-driven wearable, supported by NAVER D2SF, delivers clinical-grade sleep and respiratory insights, ensuring accessible, multi-night testing and seamless remote monitoring.

21st February, 2025

Medcrypt Enhances Helm to Help Medical Device Manufacturers Streamline Cybersecurity Compliance

With advanced SBOM management, automated vulnerability tracking, and FDA-ready reports, Helm reduces risk, lowers costs, and accelerates regulatory approval for medical device manufacturers.

20th February, 2025

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