
Medical Device Manufacturer

Provider of Health Diagnostic Products and Health Diagnostic Management Solutions
During the 42nd JPM Healthcare Conference (JPM24), global giants in the medical device field were also highly active, with Boston Scientific, Abbott, Medtronic, GE Healthcare, and others announcing their latest strategies and future development trends.
On the first day, Boston Scientific Corporation announced that it had reached a definitive agreement to acquire Axonics, Inc., a publicly traded medical technology company and manufacturer of sacral neuromodulation therapies. The acquisition price is $71 per share, with a total equity value of approximately $3.7 billion; subtracting about $300 million in cash and equivalents held by Axonics, the total enterprise value is approximately $3.4 billion.
Abbott and Tandem announced that the FreeStyle Libre 2 Plus CGM is now compatible with Tandem Diabetes Care's t:slim X2 insulin pump and Control-IQ algorithm.
Medtronic Plans Limited Release of Combo Set for Diabetes Patients Aged 7 and Above in Europe Starting Spring 2024, with Commercial Rollout Expanding Throughout Summer. The Combo Set (MiniMed 780G Pump and Simplera Sync System) marks the first integration of Medtronic's latest automated insulin pump with its newest glucose sensor, functioning as a disposable all-in-one blood glucose sensor. It can be inserted under the skin in less than 10 seconds and eliminates the need for fingersticks.
GE Healthcare Announces Plan to Acquire MIM Software, a Provider of Artificial Intelligence and Medical Imaging Analysis. The two parties have reached an acquisition agreement, and the specific financial terms have not been disclosed.
What "器械" News is Worth Paying Attention to in the Medical Device Circle This Week? Insights into New Industry Policies, Observations of Corporate Movements, and a Review of Market Investments and Financing, as Reported by the Pharmaceutical Economy News!
CMDE Solicits Relevant Units for the Development of Review Key Points and Guidelines for BNCT and Other Active Products
In order to further improve the technical review of certain active products, the Center for Medical Device Evaluation of the National Medical Products Administration has initiated the drafting of eight registration review guidelines, including the "Key Points for the Review of Boron Neutron Capture Therapy Systems (BNCT)" and the "Guiding Principles for Registration Review of Hemodynamic Monitoring Products." Relevant entities with experience, such as domestic and overseas enterprises, testing institutions, research organizations, and clinical institutions, are invited to actively participate in the drafting process.

Guiding Principles for the Registration Review of Peripheral Vascular Stent Systems (Draft for Public Comment) Released
To further standardize the registration application and technical review of peripheral vascular stent systems, the Center for Medical Device Evaluation of the National Medical Products Administration has organized the drafting of the "Guiding Principles for the Registration Review of Peripheral Vascular Stent Systems" (Draft for Comments).

This guidance principle applies to peripheral vascular stent systems, which typically consist of a stent and a delivery system. The stent is generally made of metal materials such as nitinol and usually has a mesh-like structure. After being placed intraluminally, the expanded implant provides mechanical support to maintain or restore the integrity of the vascular lumen and ensure the patency of the blood vessel.
Ophthalmic Vision Care Plans to Launch a Restricted Stock Incentive Plan of 2,699,900 Shares
On January 10, Oupukang Vision disclosed the 2024 Restricted Stock Incentive Plan (Draft). The Company's incentive plan proposes to grant 2,699,900 restricted shares, involving the type of target stock as RMB A-share common stock, accounting for 0.30% of the Company's total share capital of 897,145,269 shares at the time of the announcement of this incentive plan draft. This grant will be a one-time grant without reserved rights, and the grant price is 14.27 yuan per share.
The total number of incentive targets granted under this incentive plan is 69 people, including management personnel and core technology (business) personnel who are employed by the company (including the company's controlled subsidiaries) at the time of the announcement of this incentive plan. The validity period of this incentive plan starts from the date of granting restricted shares and ends on the date when all the restricted shares granted to the incentive targets have been fully vested or become void, with a maximum duration of no more than 72 months.
Sepure Tech's Sci-Tech Innovation Board IPO Application Approved
On January 11, the Listing Committee of the Shanghai Stock Exchange announced that the initial public offering (IPO) application of Suzhou Sepax Technologies Co., Ltd. on the STAR Market had been approved. It is reported that the company's main products include liquid chromatography media, analytical and testing liquid chromatography columns and consumables, chromatography consumables and reagents for medical diagnostic blood sample testing. The company provides customers with separation and purification process development services, as well as comprehensive industrial purification solutions including media, processes, and instrument systems.
DAAN Gene Obtains Two Medical Device Registration Certificates
On January 11, Daan Gene announced that recently, the company has obtained two medical device registration certificates issued by the National Medical Products Administration. The names are: Human APOE Genotyping Kit (PCR-Fluorescence Probe Method), and Human CYP2D6 Genotyping Kit (PCR-Fluorescence Probe Method).
Capricorn Biotech's "Human CYP2C9 and VKORC1 Gene Detection Kit (Fluorescent PCR Melting Curve Method)" Obtains Medical Device Registration Certificate
On January 11, Capricorn Biotech announced that its wholly-owned subsidiary, Guangzhou Capricorn Medical Technology Co., Ltd., had recently obtained the "Medical Device Registration Certificate of the People's Republic of China (In Vitro Diagnostic Reagent)" issued by the National Medical Products Administration.
Product Name: Human CYP2C9 and VKORC1 Gene Detection Kit (Fluorescence PCR Melting Curve Method). This product is used for the in vitro qualitative detection of genetic polymorphisms at three loci in human whole blood samples: the CYP2C9 gene c.430C>T locus (CYP2C9*2), the CYP2C9 gene c.1075A>C locus (CYP2C9*3), and the VKORC1 gene c.-1639G>A locus.
Pengyang Medical Receives B++ Round Investment from JCC Healthcare Growth Fund
Pengyang Fengye Technology Co., Ltd. (referred to as Pengyang Medical), a provider of intelligent cardiovascular diagnostic service platforms, recently completed a multi-million yuan B++ round of financing, invested by Jianchuang Medical Growth Fund. Through this round of financing and relying on the industrial support and resource advantages of the Lishui government, Pengyang Medical will accelerate the industrial implementation of its cardiovascular diagnostic service platform and the establishment of multi-center operations, laying a solid foundation and providing assurance for achieving a full-cycle cardiovascular diagnostic service ecosystem and IPO.
Pengyang Medical focuses on technological innovation and product research, development, production, and sales in the cardiovascular field. It has developed multiple intelligent monitoring and AI diagnostic product series, represented by the world's exclusive patented product—the 18-lead dynamic ECG analysis system. Twelve products have been approved for NMPA certification, three have obtained CE certification, and the company has been granted six national invention patents, twelve utility model patents, and twenty-six computer software copyrights.
EJIDA Completes Nearly 100 Million Yuan Pre-A+ Round Financing
Recently, EJET Medical Technology (Shanghai) Co., Ltd. ("EJET") has completed a nearly RMB 100 million Pre-A+ round of financing. This round was jointly led by Blue Hill Capital and Vision Plus Capital, with participation from Hotang Venture Capital. The proceeds will be used for EJET's continuous innovation, pipeline expansion, and clinical research in urology and pelvic floor health products.
"射手座" is a new generation of long-term implantable suspension bracket product independently developed by EJADA. It features suitability for a wider range of glands, one-touch operation, and reduced rates of surgical failure and equipment malfunction. While maintaining excellent surgical outcomes (e.g., basic functional evaluation indicators such as IPSS and urinary flow rate), it significantly mitigates the risks of potential complications associated with traditional procedures (such as urinary tract infections, incontinence, and sexual dysfunction). At the same time, without increasing the financial burden on patients, it simplifies what was originally an inpatient surgery into an outpatient procedure, with an extremely short learning curve.
B&A Regenerative Medicine, a Leading Company in the Regenerative Medicine Sector, Completes C Round Financing Worth Hundreds of Millions of Yuan
Bao Ao Regenerative Medicine recently completed a C-round financing of several hundred million yuan, led by Chang'an Huitong, with investments from Shaanxi Investment Growth, Xi'an Finance, and Yuhua Capital. This round of financing will mainly be used to accelerate the improvement of the regenerative medicine technology platform and the development of regenerative medicine products, as well as to deeply integrate into the regenerative medicine industry chain.
Regenerative medicine, as a discipline that utilizes the principles of cell, tissue, and organ regeneration to repair and replace damaged tissues, has ushered in a new era of reconstruction, regeneration, manufacturing, and replacement of tissues and organs for the medical industry. The industrialization of regenerative medicine can not only drive development and innovation in the medical field but also provide more effective and safer methods for human health and disease treatment. It will also attract more investment and talent, boosting economic growth and social progress.





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