Accel Groups select ten medical devices or in vitro diagnostic reagents from the monthly 510(k) clearance list (five from Chinese manufacturers and five from foreign manufacturers) for brief introductions. This aims to provide the latest global updates on medium and low-risk devices or reagents. If you have similar devices you wish to bring to the US market, please contact us at info@accelgroups.com.
Chinese Manufacturers
Polyisoprene Surgical Gloves – Suzhou Jialiwei New Material Co., Ltd.
Latex-free to eliminate allergy risks and minimize sensitivity to Type IV chemical allergies. Tested per ASTM D6978, suitable for use with various chemotherapy drugs. Applicable for all surgeries, especially high-risk orthopedic trauma and cardiac surgeries. After passing the Mouse Embryo Assay (MEA), it can be used in in vitro fertilization (IVF) procedures.
Portable Ultrasound System – Beijing Kuntai De Medical Technology Co., Ltd.
Utilizes single-crystal technology for outstanding image resolution. Can double as a protective case and portable charger, ensuring readiness at all times. Features a waterproof and dustproof design, allowing for complete immersion in compatible disinfectants for easy sterilization.
Catheter Kit – Beijing Dimak Pharmaceutical Technology Co., Ltd.
The catheter kit includes a 0.035-inch double-ended J-tip guidewire, 4 or 5F sheath, and dilator. The sheath length ranges from 25 to 85 cm, with depth markers from 35 to 65 cm. An independent dilator is provided.
Electric Wheelchair – Shanghai Bangbang Robotics Co., Ltd.
An upgraded version of a traditional manual wheelchair, enhanced with high-performance power drive components, intelligent control systems, and a battery. Powered by a lithium battery, it is rechargeable, compact, lightweight, energy-efficient, and environmentally friendly.
Disposable High-Pressure Angiographic Injector – Beijing Chao Si Electronic Technology Co., Ltd.
Suitable for CT, MR, DSA—used in computed tomography, angiography, magnetic resonance, and imaging. The included contrast agent is the gold standard for identifying cancerous tissue, presenting high-definition images of lesions. Maximum pressure can reach 350 Pa or 1200 Pa, providing enhanced high-temperature and high-pressure resistance with good breathability. The transparent body offers excellent clarity to detect bubbles and contrast agents.
Foreign Manufacturers
Miniature Orthopedic Surgery Robot – Think Surgical Inc.
Based on CT-based 3D surgical planning, the robotic arm automatically compensates for the surgeon’s hand movements to position bone pins along precisely defined planes. The cutting guide is then attached to the bone pins for accurate bone resection. The system is user-friendly and can replace many of the instruments currently used in knee replacement surgeries.
Soft Tissue Dental Laser – Fotona d.o.o.
The laser wavelengths (1064 nm and 2940 nm) are generated by a solid-state crystal laser source. Two laser wavelengths can be selected: one for optical wavelength or for deeper penetration. The system allows doctors to precisely control the laser pulse duration and energy density with the push of a button, depending on the specific application. The improved ablation efficiency of the QSP mode means that more laser energy is used for cutting, with less energy absorbed below the ablation threshold in the surrounding dental tissue, offering a method to enhance cutting speed, precision, and comfort for both hard and soft dental tissues.
Steerable Introducer – BioCardia
An 8.5 F steerable catheter used to introduce various cardiovascular catheters into the heart, including through the septum to access the left side of the heart. The bidirectional catheter features a helical pull-wire arrangement, minimizing whip during bending and providing excellent torsional stiffness for greater predictability, stability, and control during procedures.
Urology Straight Catheter – Coloplast
Features microporous technology that simplifies emptying and allows for complete bladder drainage in one free-flowing motion, reducing the risk of urinary tract infections (UTI).
Peripheral Nerve Stimulator – Nalu Medical Inc.
With the Nalu system, most patients do not feel the electrical pulses. A small percentage of patients may experience a slight tingling sensation called paresthesia. Thin wires (called leads) are placed under the skin near the nerve associated with pain, and an implanted pulse generator (IPG) is placed under the skin and connected to the leads to deliver electrical pulses.
About Accel
Accel Groups is a dedicated team of seasoned professionals in regulatory, clinical and market access. We help medical device and IVD manufacturers with complete product life cycle solutions from preclinical, strategy, clinical evaluation and trial, regulatory submission, to post market surveillance. Our regional principals have a minimum of 10+ years’ experience in their specialty to enable us to provide the regional in-depth expertise but with global one-stop shop solutions. Ask us about our Start-up kits for start-up companies with key countries regulatory pathway.
