bioMérieux Acquires SpinChip, Medtronic Launches World’s First Adaptive DBS System, and MGI’s Self-Luminous Sequencer DNBSEQ-E25 Gains NMPA Approval

Jan 19, 2025 21:25 CST Updated 21:25

Medtronic

Medical Device Manufacturer

SpinChip Diagnostics

Recently, bioMérieux, a globally renowned in vitro diagnostics company, announced that it has reached an agreement to acquire SpinChip Diagnostics ASA, a Norwegian diagnostic company.SpinChip Diagnostics ASA reaches an agreement.

SpinChip Diagnostics ASA was founded in Norway in 2012. Its compact desktop analyzer, developed with performance equivalent to high-sensitivity laboratory equipment, is particularly suitable for near-patient testing. The device can deliver results from whole blood samples within 10 minutes, making it ideal for emergency and point-of-care testing.

BioMérieux has held a minority stake in SpinChip since 2024. In March last year, BioMérieux invested 115 million Norwegian kroner (approximately 77 million RMB) in SpinChip. According to the terms of the agreement, BioMérieux will acquire 100% ownership of SpinChip at an enterprise value of 138 million euros (approximately 1.038 billion RMB). Given that BioMérieux already owns 20% of SpinChip, the cash outlay will be approximately 111 million euros (about 835 million RMB). The acquisition is expected to be completed shortly.

SpinChip Diagnostics expects to apply for CE certification for its high-sensitivity troponin I test by the end of 2025. BioMérieux announced that the first product is expected to be officially launched in 2026.

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Medtronic's Another "World's First" Approved

Recently, Medtronic announced that its BrainSense™ Adaptive Deep Brain Stimulation (aDBS) system and BrainSense™ Electrode Identifier have received CE certification in the EU and UK.

This marks the advent of the world's first approved closed-loop Deep Brain Stimulation (DBS) system, signifying a major breakthrough in the treatment of Parkinson’s Disease.

Deep Brain Stimulation (DBS) is a treatment method that involves implanting electrodes in the brain and delivering electrical signals to modulate brain activity. It is primarily used to treat Parkinson's disease, severe depression, and other movement disorders, particularly showing significant improvement in symptoms such as tremors, muscle rigidity, and bradykinesia in Parkinson's patients.

Medtronic MicroVention Europe Ltd. Voluntarily Recalls Intracranial Stent System

Beijing MicroVention Medical Technology Co., Ltd. reported that due to the stent ring being wrapped with PTFE (polytetrafluoroethylene) material, which hindered the stent from being pushed out of the delivery catheter (in-package introducer sheath), the manufacturer MicroVention Europe SARL initiated a Level 1 recall of its intracranial stent system LVIS Intraluminal Support Device (Registration No. 20213130513 for Imported Medical Devices in China). For detailed information regarding the models, specifications, and batches of the affected products, please refer to the "Medical Device Recall Event Report."

MGI Tech's "Self-Luminous" Sequencer Approved

Recently, the gene sequencer based on the self-luminescence sequencing biochemical principle — MGI’s DNBSEQ-E25 Gene Sequencer — has been approved by the National Medical Products Administration (NMPA) for medical device registration and is permitted for clinical use in the Chinese market. This means that MGI's DNBSEQ gene sequencers now cover clinical application scenarios through both "excitation light" and "self-luminescence" technologies. The number of DNBSEQ gene sequencers available for clinical testing in China will increase to 23 models. After receiving NMPA approval, the E25 can fully leverage its advantage of "anytime, anywhere" sequencing and play a significant role in clinical settings. With high cost-effectiveness in small-scale sequencing scenarios, the E25 is an ideal tool for small and medium-sized hospitals, disease control centers at all levels, customs offices, and small to medium-sized laboratories to easily establish sequencing capabilities. It supports the construction of a Healthy China and meets the growing health needs of the population.

Innovative Capsule Endoscopy System Approved for New Application

CapsoVision recently announced that the U.S. Food and Drug Administration (FDA) has approved its CapsoCam Plus system for pediatric patients aged two years and above.

CapsoVision, founded in 2006, is an innovative medical device company located in Silicon Valley. The company is mainly engaged in the research and development, production, and sales of capsule endoscopy products and is one of the leading companies in the capsule endoscopy sector. Its product, CapsoCam Plus, is the world's only capsule endoscopy system that can provide 360° panoramic images of the small intestine.

Pediatric patients can resume normal daily activities after swallowing the capsule. The user-friendly design of the retrieval system also simplifies the verification of the capsule passage, eliminating the need for additional tests or X-ray examinations. CapsoCam is also equipped with CapsoCloud, the company's advanced cloud-based software, which allows healthcare providers to easily view diagnostic results online, improving efficiency and reducing examination time.

FIRE1 Heart Failure Management System Receives FDA Breakthrough Device Designation

Recently, FIRE1 announced that it has received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA), which includes a minimally invasive sensor located within the human vein to help monitor unsafe accumulation of fluid concentration in patients. It has also been accepted into the FDA's Total Product Life Cycle Advisory Program (TAP). FIRE1’s Norm Heart Failure Management System offers patients a unique approach to managing heart failure. The Fire1 sensor is implanted in the inferior vena cava (IVC) and continuously measures the size of the IVC, providing an indication of the body’s fluid volume. Patients wear a belt reader on their abdomen for about one minute each day to retrieve readings from the sensor. The data is then sent to the patient’s clinical team at the hospital. The system is designed to alert when the patient’s condition worsens.

Over 800 Million! Latest Financing for Innovative Medical Device Company!

Recently, medical technology company CeQur announced the completion of a $120 million financing (approximately 878 million RMB). This funding will be used to drive the company's growth and accelerate commercial expansion.

CeQur is committed to providing innovative insulin delivery solutions for people with diabetes. The company plans to further expand its sales and clinical teams to drive the market promotion of the Simplicity product.

Simplicity is a patch-type insulin delivery device that breaks through traditional injection methods, eliminating the pain and inconvenience of multiple injections, and providing patients with a more convenient treatment experience.

Currently, more than 6,000 patients are using CeQur's patch-based insulin delivery device. CeQur stated that it will use the funds obtained from this financing to continue expanding and improving pharmacy channel promotion of its devices, ensuring patients can access its products more conveniently.

Editor: Wanwan