Recently, Medtronic announced that its Affera mapping and ablation system has received FDA approval for marketing in the United States. This includes the Sphere-9™ catheter and Affera™ Prism-1 mapping software. The system integrates three functions: three-dimensional mapping (HD), radiofrequency ablation (RF), and pulsed field ablation (PFA). It is used to treat persistent atrial fibrillation and tricuspid isthmus-dependent atrial flutter. Previously, it received CE mark approval in March 2023.

In addition, its Evolut FX+ Transcatheter Aortic Valve Replacement (TAVR) System has also received CE Mark approval for the treatment of symptomatic severe aortic stenosis (AS). This system had previously received FDA approval in March 2024. The Evolut FX+ features an opening size four times larger than the previous Evolut TAVR systems to facilitate access to coronary arteries with varying anatomical structures.

Notably, prior to acquiring Affera for $1 billion in 2022, Medtronic did not have its own mapping system. The recent approval of the Affera system has strengthened Medtronic's position to compete with the other three major players in the electrophysiology field (Boston Scientific, Johnson & Johnson, and Abbott). Medtronic has also become the first company globally to offer two FDA-approved PFA systems for treating atrial fibrillation. Medtronic’s PulseSelect PFA system received FDA approval in December 2023.

What "械" news in the medical device industry is worth paying attention to this week? Insights into new industry policies, observations of corporate developments, and a review of market investments and financing, all tracked and reported by the Pharmaceutical Economy News!

On November 5, the Center for Medical Device Evaluation of the National Medical Products Administration releasedNotice on Publicly Soliciting Opinions on the Directory of In Vitro Diagnostic Reagents Exempt from Clinical Trials。

In order to implement the Opinions of the General Office of the Central Committee and the General Office of the State Council on Deepening the Reform of the Review and Approval System to Encourage the Innovation of Drugs and Medical Devices (Hall Word [2017] No. 42), further standardize the clinical trial work of in vitro diagnostic reagents, and expand the scope of the List of In Vitro Diagnostic Reagents Exempt from Clinical Trials (hereinafter referred to as the In Vitro Diagnostic Reagents Exemption List), the Device Review Center has initiated the formulation and revision work of the 2024 In Vitro Diagnostic Reagents Exemption List.

Based on previous work, the Center for Devices Review has developed the "List of In Vitro Diagnostic Reagents Exempt from Clinical Trials (2024 Draft for Public Comment)," which is now open for public comment on the center's website. Meanwhile, all relevant organizations are also invited to provide suggestions for additions and revisions to the 2021 List of Exemptions for In Vitro Diagnostic Reagents (Announcement No. 70 of 2021 by the National Medical Products Administration).

Recently, the National Medical Products Administration approved the innovative product registration application for the "intracranial aneurysm embolization assist stent" from Shanghai Xinwei Medical Technology Co., Ltd.

The product consists of three parts: a stent, a delivery guidewire, and an introducer sheath. The stent is made from nickel-titanium alloy tubing through laser cutting, with platinum-iridium marker points at both ends and in the middle of some models to facilitate precise clinical judgment of stent deployment and wall apposition. Under standard interventional surgical conditions, the location of intracranial aneurysms is determined by angiography, and the device is used for endovascular adjunctive embolization and blood flow reconstruction in patients with intracranial aneurysms.

The drug regulatory department will strengthen the post-marketing supervision of this product to protect the safety of patients using the device.

Recently, the National Medical Products Administration approved the innovative product registration application for the "Knee Joint Prosthesis System" submitted by Yabone Medical Technology (Suzhou) Co., Ltd.

This product is composed of femoral components, tibial components, and patellar components, and is suitable for primary knee replacement surgery in patients with mature bone development. Among these, the femoral condyle and tibial tray incorporate trabecular porous structures manufactured using additive manufacturing processes on their bone-contacting surfaces, offering a high friction coefficient and excellent bone integration properties.

The drug regulatory department will strengthen the post-marketing supervision of this product to protect the safety of patients using the device.

Recently, Femtosecond Laser Research Center (Guangzhou) Co., Ltd., a fully independent innovation-driven label-free bioimaging technology company, announced the completion of nearly 100 million yuan in Series A financing.This round of financing was jointly led by Oriza Ventures and Taiyi Fund, with participation from Noyou Capital, Deshi Capital, and Guoju Venture Capital. Existing shareholder Yuan Yi Capital also increased its investment.

The funds from this round of financing will be mainly used for three purposes: 1. To promote the mass production of the research products in the FemtoVision (FV) series for live cell imaging and the registration of clinical products. 2. To accelerate the registration and approval, mass production, and market promotion of the FemtoIris (FI) series for tissue imaging. 3. To initiate the development of the next generation of in vivo imaging series products.

Recently, Medtronic Technology announced that the company will divest its photovoltaic cell business for a total transaction value of 6.34 billion yuan.In addition, Medtronic Technology recently established a joint venture with UBTECH Robotics, dedicated to deep cooperation in the fields of AI intelligent services and medical care, jointly creating an innovative model of "healthcare + humanoid robots."

This major asset sale is expected to help Medtronic achieve capital recovery through restructuring and focus on the development and upgrading of its core business. Medtronic officially disclosed the "Report on Major Asset Sale and Related Party Transactions," marking the company's implementation of a significant strategic adjustment.

According to the announcement, Meditech has decided to divest its photovoltaic cell business and focus entirely on the research, development, and promotion of Clinical Information System (CIS) application software and comprehensive clinical informatization solutions, further expanding its presence in the healthcare IT and medical services sectors.

Recently, Horizon Surgical Systems, which focuses on developing automated, AI-powered robotic tools for ophthalmic surgeries, announced the completion of a $30 million (approximately 210 million RMB) Series A financing round.

This financing was led by ExSight Ventures and a major corporate investor, including Main Street Advisors and the University of California. The funds will be used to further develop the Polaris surgical robot, conduct the first human study, and expand the company's team.

DayPreviously, Jierkang Medical Technology Co., Ltd. (hereinafter referred to as "Jierkang Medical") announced that its initial public offering of ordinary shares in Renminbi has been reviewed and approved by the Listing Review Committee of the Shanghai Stock Exchange.

Jianerkang Medical is a high-tech enterprise mainly engaged in the research, development, production, and sales of disposable medical devices such as medical dressings and disinfection hygiene products.

In 2020, affected by the broader environment, Jianerkang earned 1.6 billion yuan by selling masks, with a net profit of nearly 400 million yuan; afterwards, the proportion of medical dressing products increased, revenue remained around 1 billion yuan, and net profit stayed at about 100 million yuan, meeting the performance requirements for going public.

It is reported that this IPO issued a total of 30,000,000 shares, including 12,000,000 shares for online issuance and 18,000,000 shares for offline placement, with zero shares transferred from existing shareholders. The subscription code is 732205, and the maximum subscription quantity is 12,000 shares. Investors participating in online subscription are required to pay for allotted shares on October 29, 2024.

Through this IPO, Jianerkang plans to raise 720 million yuan, of which 420 million yuan will be used for high-end medical dressings, non-woven fabrics and their products projects, 55 million yuan for the R&D center construction project, and 65 million yuan for the information system upgrade and transformation project.

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