Major Global Medical Device Innovations in September 2024: From AI-Enhanced Imaging to Breakthrough Heart Failure Therapies

In September, the U.S. Food and Drug Administration (FDA) issued a statement officially reclassifying four medical devices into Class II (special controls) to strengthen regulation and ensure their safety and effectiveness, thereby improving the quality of healthcare services. These four devices include clinical chemistry and clinical toxicology devices (clozapine testing systems), immunology and microbiology devices (head and neck cancer-related virus nucleic acid detectors), therapeutic devices (pediatric continuous renal replacement therapy systems), and another immunology and microbiology device (whole exome sequencing component devices).

FDA Defines Class II Medical Devices as Products for Which General Controls Are Insufficient to Assure Safety and Effectiveness, Typically Involving Moderate to High Risk, Especially Those Related to Internal Organs, the Cardiovascular System, and Diagnostic Tools. Starting from August 2024, the FDA Has Gradually Reclassified 17 Medical Devices as Class II, with the Above Four Being the Latest Adjustments.

FDA Implements Strict Classification Management for Medical Devices, Divided into Class I, Class II, and Class III, with Increasing Levels of Risk. The Classification Expert Committee, Composed of Experts in Science, Engineering, Clinical Fields, as Well as Representatives from Consumer and Industry Organizations, Provides Classification Recommendations to the FDA. Enterprises Must Clarify Product Classification and Regulatory Requirements, Prepare Application Materials, and Submit Them to the FDA According to Procedures to Obtain Certification Approval.

September,Senseonics (NYSE: SENS) and Ascensia Diabetes Care jointly announced that their Eversense 365-Day Continuous Glucose Monitoring System (CGM) has received FDA approval in the United States. This system is the first implantable glucose sensor that can be used continuously for one year, with a usage duration twice as long as previous products.

On September 17, Boston Scientific Corporation (BSX) announced the completion of its acquisition of medical device company Silk Road Medical (SILK). Silk Road Medical is renowned for its innovative TransCarotid Artery Revascularization (TCAR) procedure, which offers a new approach to stroke prevention and the treatment of carotid artery disease.

Boston Scientific values the advantages of Silk Road Medical's TCAR procedure and products in treating carotid artery disease and preventing strokes. Compared with traditional carotid endarterectomy (CEA) and carotid artery stenting (CAS), TCAR has demonstrated a lower risk of early complications and mortality, as well as long-term stroke risk, in multiple randomized trials.

TCAR Procedure

Recently, Angio Dynamics (ANGO) announced that its Auryon laser atherectomy system received the CE mark. This innovative technology is designed for treating peripheral artery disease (PAD) and is suitable for various lesions below the groin, including above-the-knee, below-the-knee, and in-stent restenosis. The system was approved by the FDA under 510(k) clearance in the United States in 2020 and has successfully treated over 50,000 patients.

The advantage of the Auryon system lies in its intraluminal interventional approach, which accesses blood vessels through a small catheter. Compared to traditional plaque removal surgery, it causes less trauma and offers faster recovery. The high precision and energy of laser technology ensure the accuracy of the procedure while avoiding damage to surrounding blood vessels.

The development of new technologies is crucial for reducing the risk of acute vascular injury and embolic events while improving treatment efficacy. The market for atherectomy devices is experiencing significant growth, with the global market size reaching $29 billion in 2024 and expected to expand at a compound annual growth rate (CAGR) of 6.1% through 2031.

The successful approval of the Auryon system marks a significant advancement in the field of PAD treatment, providing patients with a safer and more effective treatment option.

On September 11, medical imaging company SpectraWAVE announced that it had raised $50 million in a Series B financing round for commercial expansion and new product approvals.

Its HyperVue intravascular imaging system received U.S. FDA 510(k) clearance in 2023, followed by additional clearance for enhanced functionalities, including contrast-free saline imaging and AI algorithm-based clinical structure identification. HyperVue integrates DeepOCT and NIRS technologies to optimize image quality and efficiency in the catheterization lab. OCT displays lumen and vessel wall structures, while NIRS performs spectral chemical analysis to identify lipid-rich areas.

The system also includes a catheter preparation tool that requires no flushing, a rapid pullback design, and a comprehensive AI workflow. The Starlight™ imaging catheter is suitable for vessels ranging from 2.0 to 5.2 millimeters, enabling rapid pullback between two imaging modes. Physicians can control image acquisition and AI review to optimize percutaneous coronary intervention (PCI). The system is supported by extensive clinical trials, with initial in-human studies already conducted in Colombia. Additionally, the company is developing a wireless physiology software plugin for rapid assessment of coronary pressure drops.

On September 11, global renowned medical company Getinge announced the completion of its $477 million acquisition of Paragonix Technologies. Paragonix, a leading provider of organ transport products and services in the United States, will strengthen Getinge's global medical product portfolio and enhance its ability to meet the global demand for organ transplantation.

In recent years, the transplantation market has developed rapidly and is expected to continue growing at a double-digit rate, with the market size surpassing 10 billion US dollars by 2034. Paragonix has achieved significant growth in organ preservation systems and services, with a growth rate as high as 136% in 2023, far exceeding the average market level. Since Paragonix sales are almost exclusively in the United States, there is enormous potential for global growth.

Elin Frostehav, President of Getinge's Acute Care Division, stated that Getinge is excited to enter the organ preservation and transport market, as it is rapidly developing with a global shortage of transplantable organs and a growing number of transplant surgeries. Paragonix has a strong team and proven technology that will help Getinge redefine market standards post-acquisition.

Paragonix's products include transportation and preservation systems for organs such as the heart, lungs, and liver, utilizing clinically validated cooling technology to provide medical professionals with comprehensive solutions. In the future, the two parties will leverage Getinge's global commercial infrastructure to jointly drive the global growth of this business.

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