Magbot™ incorporated advanced design features that significantly enhanced the efficiency, effectiveness, and safety of robotic magnetic catheter ablation. Robotically navigated using low-intensity magnetic fields, the Magbot™ catheter was able to reach areas of the heart that were otherwise difficult to access with traditional methods and maintain precise positioning and stability on cardiac anatomy with millimeter-level accuracy. Full integration with Columbus™ allowed real-time location tracking and 3D cardiac modeling, enabling physicians to accurately record electrocardiographic data and pinpoint lesions for the precise diagnosis and treatment of arrhythmias. A unique six-electrode design enhanced safety during procedures by providing visibility of the catheter shaft without the need for fluoroscopy. The NMPA-approved Magbot™ for the ablation of drug-resistant persistent atrial fibrillation, atrioventricular nodal reentrant tachycardia, and atrioventricular reentrant tachycardia.
“The approval of the Magbot™ Catheter signifies a major breakthrough for MicroPort EP in cardiac electrophysiology and a significant milestone for robotic navigation technology in China,” emphasized Dr. Yiyong Sun, President of MicroPort EP. “Our recent technological advances with Stereotaxis offer a safer and more precise minimally-invasive treatment solution for complex arrhythmia patients. We are excited about its potential to benefit physicians and patients alike and to strengthen our partnership with Stereotaxis to drive innovation in electrophysiology.”
As per DelveInsight’s “Surgical Robotic System Market Report”, the global surgical robotic systems market was valued at USD 5.02 billion in 2023, growing at a CAGR of 11.50% during the forecast period from 2024 to 2030 to reach USD 9.64 billion by 2030. The demand for surgical robotic systems is witnessing a surge due to increasing surgical procedures which can be attributed to various factors such as the increasing geriatric population who form a big part of the at-risk population for prostate cancer, valvular diseases, endometriosis among others, growing need for robot-assisted surgery systems due to the growing inclination towards minimally invasive surgical approaches, and the innovation in product development which is paving the way for miniaturized surgical robots ultimately contributing in the overall growth of the surgical robotic systems market during the forecast period from 2024-2030.
AngioDynamics Received FDA Clearance for NanoKnife® System for Prostate Tissue Ablation
On December 9, 2024, AngioDynamics, Inc., a leading medical technology company focused on restoring healthy blood flow in the vascular system, expanding cancer treatment options, and improving patient quality of life, announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for the NanoKnife System for prostate tissue ablation.
The company obtained clearance for the NanoKnife System for prostate tissue ablation after completing the pivotal PRESERVE clinical study and submitting the results to the FDA in September. The study assessed the safety and effectiveness of the system in ablating prostate tissue in patients with intermediate-risk prostate cancer (PCa). Conducted in collaboration with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC), PRESERVE enrolled 121 patients across 17 clinical sites.
“We are incredibly proud to receive FDA clearance for the NanoKnife System’s use in prostate tissue,” said Jim Clemmer, President and Chief Executive Officer of AngioDynamics. “This milestone is the first step in recognizing our vision to become the standard, function-preserving treatment for men with prostate tumors. The NanoKnife System minimizes the life-altering complications often associated with traditional treatments by selectively targeting prostate tissue while preserving critical functions. As we expand our global footprint and increase access to our technology, we are launching comprehensive education and awareness campaigns to empower physicians with hands-on training and clinical support while engaging patients through innovative outreach initiatives.”
As per DelveInsight’s “Radiofrequency Ablation Devices Market Report”, the radiofrequency ablation devices market was valued at USD 3.64 billion in 2023, growing at a CAGR of 9.37% during the forecast period from 2024 to 2030 to reach USD 6.19 billion by 2030. The demand for radiofrequency ablation devices is growing due to the growing prevalence of chronic diseases such as cardiovascular diseases, and cancers, the rising geriatric population, and technological advancements in product development and design improvement.
Zynex Announced Completion of Its Laser Pulse Oximetry Trial
On December 5, 2024, Zynex, Inc., an innovative medical technology company specializing in the manufacture and sale of noninvasive medical devices for pain management, rehabilitation, and patient monitoring, announced the completion of its clinical verification trial for the NiCO™ pulse oximeter.
The completion of the trial marked a key milestone required by the FDA prior to the submission of a 510(k) application for clearance to market and sell the NiCO device for clinical use. Following this achievement, Zynex moved on to final testing to ensure the operational safety of the device before submitting the 510(k) application.
The NiCO pulse oximeter utilized highly precise laser technology to directly measure blood oxygenation levels, unlike current pulse oximeters that estimate oxygenation levels using LEDs. Studies had shown that LED pulse oximeters often mismeasured oxygen levels in several populations, particularly in individuals with darker skin pigmentation.
Zynex Monitoring Solutions’ NiCO product line represented a strategic investment by Zynex to enter the multi-billion-dollar pulse oximetry market with a groundbreaking technology. The Company expressed confidence that the clinical value of NiCO’s unparalleled precision, accuracy, and safety would establish a strong foothold in this market.
The fully enrolled Phase 3 trial, which included 594 patients, was a prospective, double-blind, multicenter, saline-controlled, parallel-group, randomized control trial (RCT) of ReNu ASA for the treatment of subjects with moderate to severe symptomatic knee OA. Patients were randomized to receive a single intra-articular (IA) injection of either the saline control or ReNu. The primary endpoint was the reduction in knee pain, assessed by the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain scale, performed on subjects treated with ReNu or saline.
“The completion of our verification study is a pivotal event for Zynex Monitoring and the result of an enormous team effort. The bulk of the hard work is behind us at this point as we turn to submit NiCO for FDA clearance officially,” said Donald Gregg, President of Zynex Monitoring Solutions.
According to DelveInsight’s “Pulse Oximeters Market Report”, the pulse oximeters market was valued at USD 2.16 billion in 2023, growing at a CAGR of 10.73% during the forecast period from 2024 to 2030 to reach USD 3.98 billion by 2030. The pulse oximeters market is expanding rapidly due to the rising prevalence of respiratory conditions such as asthma & chronic obstructive pulmonary disease (COPD), coupled with advancements in technology, and rising government initiatives concerning the usage of pulse oximeters are expected to escalate the overall growth of the pulse oximeters market during the forecast period from 2024 to 2030.
Study Results From COTA, PreciseDx, and Baptist Health South Florida Validated AI Test PreciseBreast as Equivalent to Oncotype DX in Predicting Breast Cancer Recurrence
On December 9, 2024, COTA Inc., a leader in real-world data (RWD) and analytics for oncology, PreciseDx, an innovator in AI-powered digital pathology focused on oncology diagnostics, and Baptist Health South Florida announced new study results validating that the artificial intelligence (AI)-enabled PreciseBreast™ test was equivalent to the Oncotype DX test in predicting breast cancer recurrence.
Breast cancer accounted for 32% of all new cancer diagnoses in women, with one in eight women in the U.S. diagnosed with breast cancer during their lifetime. Amidst strained healthcare resources and rising breast cancer incidence, diagnostic tools harnessing the power of real-world data (RWD) and artificial intelligence (AI) proved to be valuable for improving early detection, enhancing diagnostic accuracy, and reducing time to treatment – crucial components of optimized patient care. This announcement followed a collaboration earlier in the year between COTA, PreciseDx, and Baptist Health South Florida to assess and validate the performance of the AI-enabled PreciseBreast™ (PDxBr) test in predicting the likelihood of invasive breast cancer (IBC) recurrence.
PreciseBreast is an AI-enabled digital test that integrated demographic and pathology data – such as age, tumor size, stage, and lymph node status – with early-stage invasive breast cancer biomarkers to assess the recurrence risk. After demonstrating improved risk discrimination on a Mount Sinai Health System cohort, the study extended these findings to a diverse cohort of 425 patients from Miami Cancer Institute and Baptist Health South Florida, utilizing COTA’s curated RWD. Based on six-year outcome data, the study results demonstrated equivalence between PreciseBreast and Oncotype DX.
- Identifying Recurrence: Both tests demonstrated an equivalent Negative Predictive Value (NPV) of 93%.
- Risk Classification and Treatment Decisions: PreciseBreast classified 79% of patients as low risk, while Oncotype DX identified 81% as low or intermediate risk, with both showing comparable effectiveness in supporting chemotherapy avoidance.
- Event Confirmation: Among patients who experienced recurrences, PreciseBreast correctly identified 38% as high risk, compared to 35% identified by Oncotype DX.
“AI-powered tools may have the potential to successfully augment medical practice. The results from this study demonstrate the great potential that PreciseBreast holds to fundamentally enhance cancer diagnostics and treatment precision,” said Dr. C.K. Wang, chief medical officer, COTA. “Using research-grade RWD to train and validate AI technology is critical for building trust in AI and ensuring its responsible integration into oncology practice.”
According to DelveInsight’s “Breast Cancer Diagnostics Market Report”, the global breast cancer diagnostics market was valued at USD 4.20 billion in 2023, growing at a CAGR of 6.67% during the forecast period from 2024 to 2030 to reach USD 6.16 billion by 2030. The breast cancer diagnostics market is witnessing positive growth owing to factors such as the increasing prevalence of breast cancer, increasing age and sedentary lifestyle, technological advancements, and government initiatives to increase the rate of screening and diagnosis, thereby all factors contributing to the growth of Breast cancer diagnostics market during the forecast period from 2024 to 2030.
Medtronic Launched Percept™ RC Rechargeable Neurostimulator in India
On December 5, 2024, Medtronic, a global leader in healthcare technology, launched Percept™ RC in India following its FDA approval. This device was introduced as the smallest and thinnest dual-channel neurostimulator for the Deep Brain Stimulation (DBS) system, representing the latest advancement in the Percept™ family. The rechargeable neurostimulator complemented Medtronic’s existing portfolio of devices. The Percept™ neurostimulators were the only DBS systems with integrated sensing capabilities, enabling physicians to deliver highly personalized treatments for patients with movement disorders such as Parkinson’s disease, essential tremor, dystonia, and epilepsy.
Mr. Prateek Tiwari, Sr. Director, Neuroscience and Specialty Therapies, Medtronic India said, “We are elated to bring the latest innovation in DBS technology to patients and clinicians in India. This cutting-edge solution aligns with the increasing demand for advanced healthcare innovations and promises a transformative impact on the treatment of complex neurological disorders. With its ability to deliver highly personalized, data-driven therapy, our new rechargeable Percept™ RC neurostimulator with BrainSense™ technology has the potential to significantly improve patient outcomes and offer a new hope for those managing the challenges of chronic neurological conditions. We look forward to empowering healthcare providers in India to set a new standard in precision care and enhanced quality of life.”
According to DelveInsight’s “Neurostimulation Devices Market Report”, the neurostimulation devices market was valued at USD 5.82 billion in 2023, growing at a CAGR of 11.77% during the forecast period from 2024 to 2030, to reach USD 11.34 billion by 2030. The market for neurostimulator devices is experiencing significant growth, driven by several key factors. The rising incidence of chronic diseases, such as migraine, headaches, and epilepsy, has created a greater demand for effective treatment options, leading to increased use of neurostimulators. Additionally, the prevalence of lifestyle-related diseases like depression and chronic pain has surged, further boosting the need for these devices as they offer promising solutions for managing these conditions. Technological advancements in neurostimulator devices have also played a crucial role, with regulatory bodies across the globe approving a growing number of innovative and advanced products. This regulatory support has facilitated the widespread adoption of neurostimulators, enhancing their market growth. Collectively, the increasing incidence of chronic and lifestyle diseases, along with the adoption of advanced, approved neurostimulator devices, is driving the expansion of this market during the forecast period from 2024 to 2030.
Crown Aesthetics Introduced SkinPen® Precision Elite in the US, Setting a New Standard in Microneedling
On December 10, 2024, Crown Aesthetics, a division of Crown Laboratories and a leader in the dermatologic and aesthetics medical device industry, announced the official launch of the SkinPen® Precision Elite, a revolutionary FDA-cleared device (Elite Cartridge Unit) that set a new benchmark in microneedling.
SkinPen introduced this state-of-the-art device, designed to enhance the user experience for aesthetic practitioners. The SkinPen Precision Elite featured significant upgrades, including an innovative, one-time-use, easy-to-install cartridge that minimized the risk of accidental lockouts with active retraction technology powered by the all-new ActiSine™ technology. This breakthrough ensured the smoothest glide on the skin, making it comfortable for both providers and patients and prevented common issues like scratching or dragging associated with traditional spring mechanism cartridges.
Most notably, the SkinPen Precision Elite was equipped with an Interactive Digital Display that offered intuitive guidance throughout the treatment process. Key features included prompts for cartridge installation, a battery charge indicator, and on-screen troubleshooting assistance. To streamline operations, the SkinPen Precision Elite featured an Elite Efficiency Timer (EET), helping providers maintain efficiency and optimize ROI. The device was powered by a rechargeable lithium-ion battery with inductive charging, eliminating the risk of battery failure during procedures and ensuring a seamless experience for practitioners.
“The time and dedication poured into these advancements for our flagship product, SkinPen, reflect the passion of our entire team,” said Jeff Bedard, Founder and CEO of Crown Laboratories. “With Precision Elite, we’re not just enhancing a device—we’re redefining the microneedling standard for performance, reliability, and ease of use. This launch is the culmination of years of collaboration and listening to the needs of our providers. We are proud to deliver a device that combines cutting-edge technology with meaningful feedback from the aesthetics community.”
According to DelveInsight’s “Medical Aesthetic Devices Market Report”, the global medical aesthetic devices market was valued at USD 13,533.26 million in 2023, growing at a CAGR of 11.46% during the forecast period from 2024 to 2030, to reach USD 25,808.43 million by 2030. The increase in the market for medical aesthetic devices is predominantly owing to an exponential rise in the aging population and an increase in the adoption of various aesthetic procedures. Additionally, the growing awareness among the population to look aesthetically presentable and also regarding the various cosmetic procedures performed across the globe is likely to boost the market. Also, shifting preferences towards less complex minimally invasive or non-invasive aesthetic procedures, a rise in obesity among the population, and growing technological advancement in the product arena, among others are some of the key factors expected to raise the market for these devices during the forecast period from 2024 to 2030.
