Borui Kang Updates IPO Prospectus: First Invasive Brain-Computer Interface Sells 13 Units; Joint Procurement Office Revokes One Company's Centralized Procurement Qualification

Medical News Brief · Issue 4329

October 4 · Sunday

Medical Device Professionals' Daily Intelligence Hub · Understand Major Medical Device News in 5 Minutes a Day

Today's Topic

The Commercial Ledger of the First Brain-Computer Interface Stock

? In-Depth: Neuracle Updates Prospectus, Sells 13 Units of Its First Invasive Brain-Computer Interface Product
📋 Policy: Tianjin Publicizes Two Class II Innovative Medical Devices; Joint Procurement Office Disqualifies Youkang from Winning Bid
? Global Expansion: FDA Releases FY2027 Guidance Priority List; Yisi Stapler Receives 510(k) Clearance

Neuracle Updates STAR Market IPO Prospectus: 13 Units of Its First Invasive Brain-Computer Interface Product Sold

Updated Disclosure on 2026-09-29 · Response to the First Round of Inquiries · Proposed Fundraising of RMB 2.5 Billion

? Core Summary

On September 29, Neuracle Technology (Shanghai) Co., Ltd. updated its prospectus for the initial public offering on the STAR Market and disclosed its response to the first round of regulatory inquiries, planning to raise RMB 2.5 billion. According to the prospectus, the company’s first-generation flagship product under the NEO platform, the NEO-ONE SCI (Implantable Brain-Computer Interface System for Hand Motor Function Compensation), was approved by the National Medical Products Administration in March 2026 and obtained a Class III medical device registration certificate. As reported by the STAR Market Daily, this product is the world’s first approved and marketed invasive brain-computer interface (BCI) product. In the non-invasive field, the company has launched more than 20 products. According to data from Frost & Sullivan, its electroencephalogram (EEG) machine shipments and sales revenue both rank among the top three nationwide and first among domestically produced brands. According to the response to the first round of inquiries, since July, the NEO-ONE SCI has achieved sales of 13 units, with 8 units implanted in end-users, and has secured over 70 units in hand and intended orders. The product has been listed on provincial procurement platforms in 27 provinces at a price of RMB 475,000 per unit, and expert training has been completed for relevant departments in 42 tertiary Grade A hospitals. The raised funds will be allocated as follows: RMB 1.776 billion for BCI research and development projects, RMB 174 million for production and construction projects, and RMB 550 million for supplementing working capital. Notably, the R&D budget was increased from RMB 1.54 billion in the June acceptance draft, while the production and construction budget was reduced from RMB 410 million. In the first half of 2026, the company reported operating revenue of RMB 46.344 million and a net loss of RMB 65.4797 million, with R&D expenditure accounting for 103.58% of its operating revenue.

? Background Interpretation

Brain-computer interfaces (BCIs) have been designated as a strategic direction for future industries. However, between "obtaining the registration certificate" and "selling to hospitals," there are three major hurdles: clinical access approval, online listing and pricing, and physician training. Neuracle’s prospectus provides the first quantifiable financial record for this sector: its product received regulatory approval in the first half of the year, sales commenced in July, and 13 units were sold by the end of September. This also explains why the allocation of raised funds has shifted from "production capacity building" to "R&D"—at this stage, the industry’s primary investments remain focused on product development and clinical pipelines, rather than production capacity.

? Industry Impact

This disclosure brings the pricing and adoption rate of invasive brain-computer interfaces (BCIs) into the spotlight for the first time: a listed price of RMB 475,000 per unit, sales of 13 units within three months, listing progress across 27 provinces, and training coverage in 42 Grade A tertiary hospitals collectively establish a benchmark for the pricing and promotional pacing of subsequent similar products. For supply chain companies, the more certain opportunities lie in electrodes, packaging, signal chains, and surgical accessories—the invasive approach imposes significantly higher requirements on long-term electrode stability and surgical instruments than non-invasive products.

✅ Actionable Recommendations

Two Key Points: First, pay attention to the changes in the number of NEO-ONE SCI implantations and hospital coverage disclosed in the fourth quarter and annual report, as these are the key indicators for validating the sustainability of commercialization. Second, the fact that R&D expenditure accounts for 103.58% of revenue indicates that the company is still in an investment phase; when evaluating such companies, it is important to place equal emphasis on pipeline progress and cash flow dynamics.

Source: Shanghai Stock Exchange (September 29) · Cailian Press · STAR Market Daily (September 30)

Tianjin Medical Products Administration Announces Review and Recognition of Class II Innovative Medical Devices: Two Products Proposed for Special Review Procedure

On September 30, the Tianjin Municipal Drug Administration released the public notice on the review and determination of Class II innovative medical devices (2026, Issue No. 6). According to the notice, based on the “Special Review Procedures for Class II Innovative Medical Devices in Tianjin” (Jin Yao Jian Gui [2023] No. 2), and following expert review, it is proposed to approve the inclusion of two products into the special review procedure: the “Objective Assessment System for Auditory Perception Capability” from China Electronics Cloud Brain (Tianjin) Technology Co., Ltd., and the “Disposable Artificial Lens Implantation System” from Tianjin Shiji Kangtai Biomedical Engineering Co., Ltd. The public notice period is from October 1 to October 20, 2026. For objections or feedback, please contact Wang Long at 022-63088347.

▶The Provincial Innovation Review Division constitutes the first tier of the two-tier “Provincial and Municipal Preliminary Review + National Re-examination” system: provincial-level drug regulatory authorities first organize expert reviews and publicize the results, after which the application proceeds to national-level innovation designation. For enterprises, the practical implication is that this 20-day public notice period serves as the window for filing objections and also provides a public opportunity for competitors to monitor each other’s R&D directions.

Source: Tianjin Municipal Medical Products Administration (September 30)

Joint Procurement Office Revokes Wuhan Youkang Technology’s Winning Bid Status in the Sixth Batch of Centralized Procurement: 18-Month Suspension of Bidding Eligibility

On September 30, the Joint Procurement Office for Nationally Organized High-Value Medical Consumables issued an announcement canceling Wuhan Youkang Technology Co., Ltd.’s selected bidder status in the sixth batch of nationally organized centralized procurement of high-value medical consumables. The company was placed on the list of violators, and its eligibility to submit bids for nationally organized centralized procurement of medical consumables was suspended from September 30, 2026, to March 29, 2028 (18 months). According to media reports, the product involved is the “disposable flexible ureteroscope catheter (without the function of measuring physiological pressure at the target site).” Previously, on September 28, the Hubei Provincial Drug Administration released a notice determining that the company’s quality management system had serious deficiencies and failed to comply with the Good Manufacturing Practice for Medical Devices. Accordingly, administrative measures were taken under the Measures for the Supervision and Administration of Medical Device Production, ordering the suspension of production.

▶The procedural sequence is “local production suspension first, centralized procurement disqualification second”: the drug regulatory authorities identify deficiencies in the quality system and order a production halt, after which the centralized procurement agency subsequently revokes the winning bid status. The message to winning bidders is straightforward—winning the bid is not the endpoint; compliance with the quality system is an ongoing obligation. Once production is suspended, supply assurance will be taken over by alternative suppliers, and market share will consequently shift.

Source: Hubei Provincial Medical Products Administration (September 28) · Joint Procurement Office for National Organization of High-Value Medical Consumables (September 30)

Mindray Medical Dangshan Medical Technology Industrial Park Opens: Total Investment of RMB 2 Billion, Positioned for Precision Machining of Core Components

On September 30, Mindray Medical announced the opening of its Dangshan Medical Technology Industrial Park. According to the company’s official website, the park was signed in 2020 and construction began in 2022. Covering an area of approximately 298 mu, it is one of Mindray’s seven global supply chain bases, focusing on the precision machining and production of human implantable devices such as bone screws, nano-ceramic glass, polymer materials, and metal materials. According to a report by Zhong’an Online on September 3, 2025, the total investment in the project amounts to RMB 2 billion, with a total construction area of nearly 200,000 square meters, of which nearly 100,000 square meters are designated for precision machining workshops. At present, the production lines are divided into three major categories: precision machining for general surgery, precision machining and injection molding for instruments, and assembly of core instrument components. Mass production has been achieved for products including ultrasonic scalpel shafts, bone screws, ceramic plungers, blood pressure cuffs, and SpO2 probes. The output value reached RMB 70.6081 million in 2024. According to reports on the park’s opening, the output value increased to RMB 234 million in 2025, and upon full completion, the park is expected to provide 1,500 jobs.

▶This analysis focuses on the direction of "in-house manufacturing of components." Historically, the weakness of domestically produced imaging and surgical equipment often lay in precision machining. Bringing key components such as bone screws, ceramic parts, and ultrasonic scalpel shafts into its own industrial park means that costs and delivery schedules are now under its control. It is worth noting that the park is still in a ramp-up phase—its output value was RMB 70.6081 million in 2024 and increased to RMB 234 million in 2025. While the ramp-up speed is not slow, there is still a gap compared to the scale of traditional complete-unit production lines.

Sources: Mindray Medical (September 30) · MedTech Home (September 30) · Zhong'an Online (September 3, 2025)

Lead Health Technology (Guangzhou) Completes Tens of Millions of Yuan in Pre-A++ Round Financing: Shanghai International Group Leads Investment

Recently, Lead Health Technology (Guangzhou) Co., Ltd. announced the completion of its Pre-A++ financing round, raising tens of millions of yuan. This round was strategically invested by Shanghai International Group Investment Co., Ltd. According to the company’s official website, Lead Health was established in October 2023. It independently develops life science instruments, biopharmaceutical equipment, associated consumables, and algorithm systems centered around the cell industry chain. Its product portfolio covers areas such as single-cell multi-omics characterization, high-throughput AI-based cell observation and sorting, cell and organoid culture, live-cell imaging, and protein purification. As reported on September 28, the company has launched more than 20 products. The funds from this financing round will be primarily used for business layout in the East China region, talent acquisition, development of AI for Science initiatives, capacity expansion, and market channel construction.

▶The key highlight here lies in “life science tools + AI integration”: the cell preparation and biomanufacturing segments have long been dominated by imported instruments, while domestic manufacturers are pursuing substitution across the entire chain, from observation and sorting to culture. It is worth noting that their product portfolio spans both research instruments and medical devices, which differ in the degree of medical device classification and regulatory pathways; therefore, the progress of clinical registration submissions following financing warrants close monitoring.

Source: Lead Health Technology (September 30) · Cailian Press · STAR Market Daily (September 30)

[Overseas Policies]

FDA Releases Fiscal Year 2027 Guidance Priority List: Draft Guidance on the Lifecycle of AI-Enabled Devices

On October 1, the U.S. FDA released the Priority List of Medical Device Guidance Documents for Fiscal Year 2027. According to RAPS, citing the FDA’s official list, the highest-priority items include: finalizing the “Guidance on Marketing Submission and Lifecycle Management for AI-Enabled Devices” (draft released in January 2025); drafting evidence recommendations for generative AI-enabled conversational devices for mental health conditions (not included in the previous fiscal year’s list); and accelerating the finalization of the guidance on premarket submissions for robot-assisted surgical devices, released on September 25. The list comprises 11 Category A priority final documents and 3 Category B priority draft documents. The Predetermined Change Control Plan (PCCP) guidance remains listed as a legacy item. Category B also includes the finalization of the pulse oximetry guidance. The deadline for comments is November 30, 2026, submitted to docket FDA-2012-N-1021.

▶This list highlights three key points for Chinese companies to note: First, the requirements for “post-market continuous learning” of AI medical devices are nearing finalization, necessitating advance planning for model change management and data governance. Second, generative AI-powered mental health conversational devices have received specialized evidentiary guidance for the first time. Third, the Predetermined Change Control Plan (PCCP) has remained on the list for two consecutive years—incorporating anticipated changes into the authorized scope is transitioning from a competitive advantage to a standard practice.

Source: U.S. FDA (October 1) · RAPS (October 1)

[Overseas Approval]

Shanghai Yisi Medical's Electric Endoscopic Stapler Receives FDA 510(k) Clearance

According to the U.S. FDA database, Shanghai Yisi Medical’s independently developed electric laparoscopic stapler, easyEndo E-Lite, received 510(k) clearance on September 25, 2026 (Clearance Number K254291; approximately 268 days from acceptance to decision). According to the company’s official website, the product features one-button electric firing, 120-degree large-angle articulation, short jaws adapted for confined spaces such as the pelvic cavity, and a patented detachable beak design, which can reduce the learning curve and the frequency of instrument exchanges. The company states that its self-developed products have entered nearly 90 countries and regions worldwide, with cumulative sales exceeding 5.2 million units; it had previously been included in the Vizient Group Purchasing Organization catalog.

▶A noteworthy strategy is the pathway: first enter the GPO catalog, then obtain registration approval—establishing channel access upfront so that products can immediately enter hospitals upon regulatory clearance. In the North American market, Chinese-made high-value consumables face incumbent competitors such as Ethicon and Medtronic. Product differentiation (e.g., large-angle steering and adaptability to confined spaces) often proves more effective than price in gaining initial market entry.

Source: U.S. FDA (September 25) · Shanghai Yisi Medical (September 25)

Tanner Health Deploys PMcardio Across Its Entire Network: AI-Powered ECG Integration into the Full Emergency Care Workflow

On October 1, Tanner Health in Georgia, USA, announced the system-wide commercial deployment of the PMcardio AI platform, covering western Georgia and eastern Alabama. According to the company’s announcement, this marks the first such deployment of its kind by a healthcare system in the United States. At the core of the platform is the “Queen of Hearts” ECG AI model developed by Powerful Medical, designed to identify acute coronary syndromes, including occult occlusive myocardial infarctions that are often missed by traditional STEMI criteria. The platform has been integrated into the Epic electronic health record (EHR) system and synchronized with emergency care workflows. It is accessible across 911 ambulances, community hospital emergency departments, and heart centers. After healthcare providers complete a 12-lead electrocardiogram, the AI provides real-time assessments shared with the care team, facilitating earlier cardiology consultations and timely decisions regarding catheterization lab activation.

▶The value of AI-enabled ECG lies not in “detecting one additional condition,” but in shifting diagnostic decision-making earlier to the ambulance setting: while the ECG data is still being transmitted, the algorithm has already generated a conclusion, allowing the catheterization lab to be activated in advance. The key highlight here is the deployment model—rather than licensing a single device, it involves platform-based implementation covering the entire emergency care continuum. For similar domestic products, the next major hurdle will be achieving seamless integration between pre-hospital emergency systems and in-hospital electronic medical record systems.

Source: Powerful Medical (October 1) · Business Wire (September 30)

OSMUNDA Perspective · OSMUNDA VIEW

The Distance from "Obtaining the Certificate" to "Selling Out"

Neuracle’s disclosure lays bare, for the first time, the commercial ledger of invasive brain-computer interfaces (BCIs): a listed price of RMB 475,000 per set, 13 units sold within three months, procurement listing completed in 27 provinces, and training delivered at 42 Grade-A tertiary hospitals. For competitors in the same field, these figures serve as both a benchmark and a reminder: what truly determines the pace of adoption is not technical specifications, but rather hospital access, physician training, and reimbursement arrangements. The competitiveness of medical devices must ultimately be validated in both the operating room and on the financial statements.

Source: Compiled by OSCADA

— Data Snapshot —

47.50

Ten Thousand Yuan/Set: The listed prices for NEO-ONE SCI have been completed in 27 provinces.

According to the updated STAR Market prospectus and the response to the first round of inquiry letters disclosed by Neuracle Technology on September 29, its implantable brain-computer interface hand motor function compensation system, NEO-ONE SCI, has been listed on the procurement platforms of 27 provinces in China, with a listing price of RMB 475,000 per set. Since July 2026, the product has achieved sales of 13 sets, completed terminal implantation for 8 sets, secured over 70 sets in hand and intended orders, and completed expert training for relevant departments in 42 top-tier tertiary hospitals across China.

— Word of the Day —

Motor Function CompensationMotor Function Compensation

This refers to an intervention pathway that, following damage to neural pathways, does not rely on the self-repair of the damaged site but instead utilizes external devices to substitute for or compensate for motor function. According to Neuracle Technology (Shanghai) Co., Ltd.’s updated prospectus for listing on the STAR Market, released on September 29, the registered name of its NEO-ONE SCI product is the “Implantable Brain-Computer Interface System for Compensation of Hand Motor Function.” The prospectus states that the system, designed for patients with quadriplegia resulting from cervical spinal cord injury, was approved by the National Medical Products Administration and obtained a Class III medical device registration certificate in March 2026.

Technical Key Points ·The boundary between “compensation” and “treatment” is key to regulatory review and promotional claims: compensatory products do not claim to restore damaged nerves per se, but rather aim at functional substitution; thus, clinical evaluation focuses on functional improvement and safety of use, rather than on disease cure rates.

— Morning Greetings —

“Obtaining certification is merely the ticket to entry; sales are the true report card: Brain-computer interfaces are now speaking in ‘units sold.’”

— A Shared Commitment with Medical Device Professionals

Today's Source:Shanghai Stock Exchange · Cailian Press · Science and Technology Innovation Daily · Tianjin Municipal Medical Products Administration · Hubei Provincial Medical Products Administration · Joint Procurement Office for High-Value Medical Consumables Organized by the State · Mindray Medical · MedDevice Home · Anhui Online · Lead Health Technology · U.S. FDA · RAPS · Shanghai Easysight Medical · Powerful Medical · Business Wire · Osida

[Disclaimer] The content of this morning briefing is sourced from public channels and is intended solely for reference and exchange among professionals in the medical device industry. It does not constitute any legal, regulatory, or compliance advice. For authoritative information, please refer to the original official texts.

— Medical News Morning Brief · Issue 4329 · See You Tomorrow —

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