GE Healthcare Acquires Full Stake in Nihon Medi-Physics, Siemens Healthineers Announces $105M Collaboration, and Four Medical Device Registrations Revoked

Dec 08, 2024 12:30 CST Updated 12:30

Nihon Med-Physics

Radiopharmaceuticals and Diagnostic Reagents R&D Manufacturer

GE Healthcare

Digital Solution Provider

On December 2, GE Healthcare announced that it will acquire the remaining 50% stake in Nihon Medi-Physics (NMP), a leading Japanese radiopharmaceuticals company, from Sumitomo Chemical, thereby assuming full ownership of Nihon Medi-Physics Co., Ltd. (NMP). Sumitomo Chemical and GE Healthcare expect the transaction to be completed in early 2025, subject to regulatory approval.

NMP, headquartered in Tokyo, was founded in 1973 and generated revenue of 28.2 billion yen (approximately 183 million USD or 1.368 billion CNY) in 2023. In addition to its 13 manufacturing plants, NMP focuses on R&D, including non-clinical and clinical development of radiotracers and theranostic drugs. Since the acquisition of Amersham plc in 2004, GE Healthcare has held a 50% stake in NMP and occupies three seats on its board of directors.

As part of GE Healthcare, NMP will leverage its expertise to develop and manufacture proprietary and licensed radiopharmaceuticals for Single Photon Emission Computed Tomography (SPECT) and Positron Emission Tomography (PET) molecular imaging procedures to detect and diagnose diseases. NMP's portfolio includes radiopharmaceuticals used in clinical imaging for neurology, cardiology, and oncology procedures. Examples include VIZAMYL® Injection, a radiotracer for amyloid visualization in the Alzheimer's pathway; DaTSCAN® Injection for evaluating patients suspected of having Parkinson's disease or dementia with Lewy bodies; and MYOVIEW® for SPECT myocardial perfusion imaging to assess known or suspected coronary artery disease.

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Four Medical Device Registration Certificates Cancelled

In accordance with the Regulations on the Supervision and Administration of Medical Devices, and based on the enterprise's application, the National Medical Products Administration hereby cancels the following:Medical Device Registration Certificates for 4 Products from 3 Companies:

1. Two products of Lutronic Corporation: Intense Pulsed Light Therapy Device, Registration Certificate No.: China Medical Device Registration No. 20182091613; Carbon Dioxide Laser Therapy Device, Registration Certificate No.: China Medical Device Registration No. 20173016670.

2. One product from XINTEC CORPORATION DBA CONVERGENT LASER TECHNOLOGIES, a U.S.-based company: Vectra TM Family of Laser Systems and Accessories (Semiconductor Laser Therapy Device and Accessories), Registration Certificate No.: China Medical Device Registration No. 20163011953.

3. One product of Kowa Company, Ltd.: Non-contact tonometer, Registration Certificate No.: China Medical Device Registration No. 20212160354.　　

"Key Points for Registration Review of Remote Transmission Function in Medical Devices" Open for Public Comment

According to the requirements of the second batch of key projects "Research on the Safety and Effectiveness Evaluation of Medical Device Products Based on Remote/Wireless Transmission Technology" in the China Drug Regulatory Science Research Action Plan by the National Medical Products Administration, our center has organized the drafting of the "Key Points for Registration Review of Remote Transmission Functions of Medical Devices." After research and discussion, a draft for public comment has been formed and is now open for online public feedback starting today.　　

Siemens Healthineers Announces €760 Million in New Collaborations

Recently, Siemens Healthineers announced that it has signed a contract with the Wexner Medical Center at Ohio State University for a period ofA 10-year, $105 million (approximately 760 million RMB) agreement to accelerate clinical care innovation.The partnership will focus on diagnostic and therapeutic imaging in radiology and radiation oncology, artificial intelligence, and machine learning, aiming to expand care opportunities for underserved patients.The two parties will create a "Center of Excellence for Imaging" and jointly develop technologies to enhance patient care, leveraging their combined strengths to benefit local and global patients.

The Ohio State University Wexner Medical Center, located in Columbus, Ohio, is a renowned academic medical institution celebrated for its comprehensive patient care, cutting-edge research, and top-tier educational programs. As part of The Ohio State University, it encompasses various specialty hospitals, including the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, which provide advanced cancer care and innovative research initiatives.

China's National Healthcare Security Administration Advances the Construction of a Medical Insurance Imaging Cloud Sharing Path

Recently, the National Healthcare Security Administration (NHSA) announced at the launch ceremony of the medical insurance imaging cloud sharing pathway held in Nanjing, Jiangsu, that it is accelerating the construction of this pathway. Efforts are being made to enable healthcare institutions across China to access medical imaging information from leading medical centers in Beijing, Shanghai, Guangdong, and other prominent regions via the national medical insurance imaging data cloud sharing center as soon as possible.The Medical Insurance Imaging Cloud enables doctors to quickly access patients' historical examination data and make diagnoses by storing and sharing medical imaging data in the cloud.The massive amount of medical imaging data gathered on this platform can be intelligently analyzed to effectively identify improper behaviors in the use of medical insurance funds. Additionally, through AI training, it can promote advancements in intelligent diagnostic technology, disease research, and new drug development.

China's National Healthcare Security Administration Seeks Opinions on the Generic Names for 7 Types of Medical Consumables under Medical Insurance

ForEstablish a standardized and unified medical insurance generic name system, merge similar items for consumables with similar functions and minor differences in clinical value, reasonably determine the medical insurance generic names, and address current issues such as difficulty in identifying, distinguishing, clinically selecting, and managing medical consumables under medical insurance.On November 30, the National Healthcare Security Administration organized efforts to revise the medical insurance generic names (hereinafter referred to as "medical insurance generic names") for seven categories of medical consumables, including vascular interventional stents, and publicly solicited opinions.

It is of great significance to promote the establishment and improvement of the medical consumables Medicare access system, and to help make Medicare payment more scientific, meticulous, and efficient. It also helps standardize and guide technological innovation in the medical device field, promoting the development of new quality productive forces. The categories for this consultation include vascular stents, vascular interventional balloons, staplers and accessories, artificial trachea, tissues and accompanying materials, non-vascular interventional stents, non-vascular interventional balloons, and implantable cardiac rhythm management devices.

Editor: Vanilla