A Proof of Concept Study on Blood Collection and Storage Using 3D Printed Caps and Sterilized 500ml Beverage Bottles – Part 2

A Proof of Concept Study on Blood Collection and Storage Using 3D Printed Caps and Sterilized 500ml Beverage Bottles - Part 2

Study on Blood Collection and Storage Using 3D Printed Caps and Sterilized 500mL Beverage Bottles Background and Purpose During wars and crises, disruptions in the blood supply chain force the search for innovative blood collection solutions. This document reports in detail on a feasibility and safety study of using 3D printed caps (BC2L) with standard … Read more

Overview of NMPA Registration for Ultrasound Imaging Diagnostic Equipment in China

Overview of NMPA Registration for Ultrasound Imaging Diagnostic Equipment in China

Advantages of Ultrasound Imaging Diagnosis include non-invasive, painless, and free from ionizing radiation, with high sensitivity and resolution, supporting repeated diagnoses. It is currently one of the best clinical examination methods for real-time observation of the internal structure of the heart. In clinical applications, ultrasound imaging diagnosis is becoming increasingly important. 1. Structural Composition The … Read more

List of Regulatory Standards and Websites for IVD (In Vitro Diagnostic Reagents/Devices) and MD (Medical Devices) in China, Europe, and the USA

List of Regulatory Standards and Websites for IVD (In Vitro Diagnostic Reagents/Devices) and MD (Medical Devices) in China, Europe, and the USA

Core Principles: Official Priority: The official websites of the regulatory authorities for drugs and medical devices in various countries/regions (NMPA, EC/EU, FDA) are the most authoritative sources for obtaining original regulations, guidelines, databases, and the latest updates. Standards Organizations: International standards organizations (ISO, IEC) and national standard organizations (such as SAC in China, ANSI in … Read more

Case Study on Femtosecond Laser Depth Etching for Removing PI Coating from Medical CGM Sensors

Case Study on Femtosecond Laser Depth Etching for Removing PI Coating from Medical CGM Sensors

With the rapid development of manufacturing processes, the complexity of miniaturized devices is increasing day by day. In cutting-edge industries such as microelectronics, medical technology, and photonics, micro-devices often adopt multilayer stacked structures made of different materials to meet increasingly complex multifunctional requirements. Especially in the healthcare sector, the application of Continuous Glucose Monitoring (CGM) … Read more

Intravascular Shockwave Balloon Catheter: Key Shockwave Patent Invalidated, Is a Spring for Domestic Devices Approaching?

Intravascular Shockwave Balloon Catheter: Key Shockwave Patent Invalidated, Is a Spring for Domestic Devices Approaching?

Introduction Vascular calcification is a common pathological manifestation associated with atherosclerosis, hypertension, diabetic vascular lesions, vascular injury, chronic kidney disease, and aging. It primarily manifests as increased stiffness of the vascular wall, decreased compliance, and can easily lead to myocardial ischemia, left ventricular hypertrophy, and heart failure, triggering thrombosis and plaque rupture, making it one … Read more

Advancements in Magnetic Microrobots for Cancer Treatment: Performing Specific Tasks Independently

Advancements in Magnetic Microrobots for Cancer Treatment: Performing Specific Tasks Independently

The limbs of the LEGO figure in the image can move independently because the magnetic screws connecting its limbs are in a specially designed layered magnetic field. On February 23, Beijing time, foreign media reported that a recent study suggests that magnetically controlled microrobots may one day help us combat cancer. Over the past decade, … Read more

Exoskeleton Robots: Four Industry Leaders

Exoskeleton Robots: Four Industry Leaders

Exoskeleton robot industry chain listed companies and business layout analysis1. Zhenjiang Co., Ltd. (603507) ◦ Core business: The holding subsidiary Haipuman Robotics focuses on the research and development of industrial exoskeletons, utilizing bionic structural design and continuous carbon fiber 3D weaving technology, resulting in a 50% reduction in product weight, suitable for high-altitude operations and … Read more

Managing and Securing Medical Devices through IoT

Managing and Securing Medical Devices through IoT

The value generated by data far exceeds the value of global goods trade —— McKinsey “Digital Globalization” (2016) Protect Your Devices to Protect Your Patients The quality of patient care is at the core of healthcare. In a rapidly evolving world of medical devices, software is at the center of innovation, with manufacturers shifting from … Read more

3D Printing a Kidney? Where Are We in the Development of Artificial Kidneys?

3D Printing a Kidney? Where Are We in the Development of Artificial Kidneys?

3D printing technology has entered the medical field, particularly in orthopedics. For example, through 3D printing technology, it is possible to create highly precise and personalized bone prosthetics that are best suited for patients, which can better assist doctors in handling some difficult cases. Therefore, many kidney patients are very concerned about this issue! Since … Read more

The Ambition of Smartwatches: Huawei Enters the Medical Device Market, Aiming to Dominate Digital Healthcare?

The Ambition of Smartwatches: Huawei Enters the Medical Device Market, Aiming to Dominate Digital Healthcare?

Say goodbye to nightmares? The Apple Watch application NightWare has recently received approval from the U.S. Food and Drug Administration (FDA) for market sales. NightWare, which sounds like “nightwear,” uses data from the smartwatch’s motion and heart rate to detect the wearer’s nightmares and vibrate the wristband accordingly, interrupting nightmares without disturbing sleep, effectively terminating … Read more