FDA Recalls Abbott's Heart Failure Devices Amid Fatalities; Johnson & Johnson Reports Q1 Revenue of $21.38B; Innovative Medical Devices Enter Special Review

Apr 21, 2024 13:43 CST Updated 13:43

Johnson & Johnson

Medical Device R&D and Manufacturer

Abbott

Provider of Health Diagnostic Products and Health Diagnostic Management Solutions

Recently, Johnson & Johnson (hereinafter referred to as "J&J") announced its Q1 financial report for the fiscal year 2024, with total revenue of $21.383 billion (approximately RMB 154.789 billion), representing a year-on-year increase of 2.3%.

Financial reports show that Johnson & Johnson's medical technology business revenue reached $7.821 billion (approximately RMB 56.633 billion), a year-on-year increase of 4.5%. The full-year operational sales growth was 6.3%, primarily driven by electrophysiology products in the cardiovascular field, EDOF intraocular lens products in the vision field, and biosurgery products in the advanced surgery field. Johnson & Johnson forecasts its total sales for 2024 to be between $88.7 billion and $89.1 billion, higher than the previous estimate of $88.2 billion to $89.0 billion.

By region, the medical technology business achieved sales of $4 billion (approximately RMB 28.965 billion) in the U.S., representing a year-over-year increase of 6.6%; international sales reached $3.81 billion (approximately RMB 27.589 billion), marking a year-over-year growth of 2.4%.

By field, the sales revenue in the surgical field was $2.416 billion (approximately RMB 17.495 billion), representing a year-on-year increase of 0.7%; the sales revenue in the orthopedics field was $2.340 billion (approximately RMB 16.944 billion), representing a year-on-year increase of 4.3%; the sales revenue in the cardiovascular field was $1.806 billion (approximately RMB 13.077 billion), representing a year-on-year increase of 20.2%; the sales revenue in the vision field was $1.258 billion (approximately RMB 9.109 billion), representing a year-on-year increase of 3.3%.

What "instrument" 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 are all covered in "Pharmaceutical Economy News"!

Insights into New Industry Policies

Guidelines for the Inspection of Quality Management Standards for the Production of Artificial Intelligence Medical Devices Released

Recently, the Beijing Municipal Drug Administration formulated and released the "Beijing Artificial Intelligence Medical Device Production Quality Management Standard Inspection Guidelines (2024 Edition)" to strengthen quality and safety supervision, promote high-quality development with new productive forces, and fully ensure the healthy development of Beijing's artificial intelligence medical device industry.

The guideline starts from the key links that affect the whole life cycle quality and safety of artificial intelligence medical devices, making specific regulations on regulatory requirements, inspection priorities, and inspection methods for demand analysis, data collection, algorithm design, verification and validation, update control, traceability analysis, continuous learning, and adaptive learning in the process of research and development, production, and after-sales use of related products. While guiding regulators on "what to inspect, how to inspect, and how to handle identified issues," it also instructs relevant enterprises in Beijing to scientifically improve their quality management systems.

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Observation of New Trends in Enterprises

FDA Recalls Heart Failure Devices Linked to Injuries and Deaths

Recently, the FDA announced a recall of the HeartMate II and HeartMate 3 devices produced by Thoratec Corp., a subsidiary of Abbott Laboratories, due to these devices causing 273 injuries and 14 deaths. Approximately 14,000 devices are affected, but they have not yet been removed from the market. These devices are used to support patients with severe left ventricular heart failure by replacing the pumping function of the heart. However, in rare cases, the accumulation of biological material can form clots, leading to device blockage and potential injury or death. It is understood that Thoratec has notified all affected customers of this recall.

A batch of innovative medical devices enters the special review process

On April 19, according to the announcement of the review results of the special review application for innovative medical devices (No. 4 of 2024) published on the official website of the Center for Device Review of the National Medical Products Administration, a batch of innovative medical devices has entered the special review process.

According to the requirements of the National Medical Products Administration's "Special Review Procedure for Innovative Medical Devices" (Announcement No. 83 of 2018 by the National Medical Products Administration), the Office for the Review of Innovative Medical Devices organized relevant experts to review applications for the special review procedure. The following seven application projects are proposed to enter the special review process: Intravascular Left Ventricular Assist System (Shanghai Heart Power Ray Medical), Disposable Coronary Intravascular Shockwave Guidewire and Intravascular Shockwave Treatment Device (Shanghai MicroPort Melody Medical), Intraocular Lens (Tianjin Century Kangtai), Transcatheter Myocardial Radiofrequency Ablation System (Hangzhou Dejin Medical), Transcatheter Mitral Valve System (Jiangsu Zhenyi Medical), MRI-monitored Semiconductor Laser Therapy Equipment and Disposable Laser Fiber Kit (HuaKe Precision), Carotid Artery Stent System (Suzhou Zhongtian).

China's First "Combination Blood Glucose Meter" Approved for Marketing

Recently, the National Medical Products Administration approved the innovative product registration application for the "Combined Blood Glucose Meter" by Jiangsu Jingce Medical Technology Co., Ltd.

The product consists of an invasive blood glucose detection module, a non-invasive blood glucose detection module, a metabolic heat probe, an ambient temperature and humidity monitoring module, and a display screen. It serves as a supplement to the existing fingertip blood glucose monitoring and is suitable for daily self-blood glucose monitoring by patients with type 2 diabetes. The product estimates blood glucose concentration through non-invasive detection of metabolic heat levels, which is a first in China. Patients with diabetes can achieve blood glucose measurement by measuring the dynamic characteristics of deep oral temperature, helping to reduce patient discomfort and lower measurement costs.

Market Investment and Financing Review

Zhi Qin Instruments Completes Tens of Millions of Yuan in A+ Round Financing

Recently, Shenzhen Zhiqin Instrument Co., Ltd. completed an A+ round of financing worth tens of millions of yuan and was renamed Zhiqin Instrument (Hefei) Co., Ltd. This round of financing was jointly invested by Hefei Feixi Industrial Investment, Hefei Innovation Investment, and Shenzhen Junsheng Runshi, with Shenzhen High-Tech Investment acting as the exclusive financial advisor for this round. The funds raised in this round will be used for investments in Zhiqin's headquarters, R&D, and production base construction.

The head of Feixi Industrial Investment team stated: "This investment sees Feixi Industrial Investment joining hands with Zhiqin Instruments to jointly explore a new phase in the development of the mass spectrometer industry. We aim to support Zhiqin Instruments in continuously achieving greater success and realizing the miniaturization, China-based production, and industrialization of high-performance mass spectrometers. Feixi Industrial Investment will grow together with Zhiqin Instruments."

Intalight Secures Over 100 Million Yuan in Series D Financing Again

Recently, following the over 300 million yuan C-round financing in 2023 and a strategic financing of tens of millions from Huaxia Eye Group, Intalight Saiwei – Viewlight Imaging (Henan) Technology Co., Ltd. (hereinafter referred to as "Intalight Saiwei" or "Viewlight Imaging"), a global high-end optical ophthalmic diagnosis and treatment equipment brand, received another capital boost. It has recently completed a D-round financing of over 100 million yuan led by Haitong Kaiyuan. The funds will mainly be used to increase R&D investment, expand product lines, and accelerate overseas market layout.

Shen络 Medical Completes Hundreds of Millions of B+ Round Financing

Recently, Hangzhou Shenluo Medical Technology Co., Ltd. announced that it has secured hundreds of millions of yuan in B+ round financing. This round of financing was led by OrbiMed, with participation from existing shareholder Boyuan Capital. The funds will mainly be used for the company's new product development, clinical research, registration applications, core technology iteration, and commercial expansion. Currently, the company has successfully developed multiple implantable neurostimulators for different diseases. Some products have completed clinical enrollment, while others are about to initiate clinical trials.

Editor: Cheng Lin