“We are extremely pleased that the EU market approval includes all designs and a vast number of indications. We can now immediately begin offering all RemeOs™ Trauma Screws to patients across Europe. Moreover, this approval paves the way for market entry into non-European countries that recognize the CE mark, and it empowers us to collect real-world clinical evidence. This evidence will enable the expansion of indications in the U.S., where the current approval is more limited,” comments Alan Donze, CEO of Bioretec.
As per DelveInsight’s “Orthopedic Implants Market Report”, the global orthopedic implants market is estimated to grow at a CAGR of 5.46% during the forecast period from 2024 to 2030. The orthopedic implants market is slated to witness prosperity owing to factors such as the increasing prevalence of orthopedic diseases such as arthritis, osteoporosis, and others, a growing burden of the geriatric population, the rising number of road accidents associated and other injuries, and the growing focus on improving the safety, affordability, and usability of orthopedic implants for people are further expected to result in the appreciable revenue growth in the orthopedic implants market during the forecast period 2024 to 2030.
South Korea’s Ministry of Food and Drug Safety (MFDS) Recognized HoneyNaps’ AI Sleep Diagnostic Software as 73rd and 74th Innovative Medical Device
On February 03, 2025, HoneyNaps a leading company in AI-based sleep data analysis, announced that the AI-powered sleep disorder diagnostic software “SOMNUM”, and its second-generation digital therapeutic for insomnia, “SOMNUM Medella, been designated as innovative medical devices by South Korea’s Ministry of Food and Drug Safety (MFDS).
Innovative medical devices are advanced technologies integrated with high-intensity innovations in fields such as information technology, biotechnology, and robotics. These devices offer significantly enhanced safety and efficacy compared to conventional products. The MFDS designates innovative medical devices in areas like AI medical devices, digital therapeutics, and robotic surgical systems. Products with this designation provides various benefits, such as expedited regulatory review processes and preferential participation in government-supported programs.
A representative from HoneyNaps commented, “For over a decade, we have focused on developing solutions spanning the entire spectrum of sleep data sensing, analysis, diagnosis, and treatment. We are thrilled that our technological innovations and efforts have been officially recognized through this designation.”
As per DelveInsight’s “Sleep Tech Devices Market Report”, the global sleep tech devices market was valued at USD 16,941.46 million in 2023, growing at a CAGR of 17.31% during the forecast period from 2024 to 2030 to reach USD 44,038.42 million by 2030. The demand for sleep tech devices is primarily being boosted by the increasing patient population suffering from various sleep disorders such as insomnia, obstructive sleep apnea, and others, the surge in cases of depression, increasing number of risk factors such as obesity and smoking among others associated with causing poor sleep, rise in the number of sleep awareness campaigns and programs highlighting the importance of sleep, and innovation in product development among others, thereby contributing to the overall growth of the sleep tech devices market during the forecast period from 2024 to 2030.
Movano Health Initiated Clinical Research on Innovative Cuffless Blood Pressure Monitor
On February 04, 2025, Movano Health announced that it started a blood pressure clinical trial using its newly developed cuffless blood pressure wrist wearable. The study, which included at least 70 participants and was expected to conclude in the second week of February, utilized the updated device to monitor pulse pressure waveforms against a hospital-grade blood pressure device. The wearable also gathered data on various vital signs, including pulse rate, blood oxygen saturation (SpO2), respiration rate, and ECG waveforms.
“We have learned a great deal since our last clinical trial in November 2024 and have refined the use of our proprietary cuffless blood pressure wearable to extract higher fidelity data,” said Movano Health’s CTO and Founder Michael Leabman.
The February 2025 study followed three clinical trials that took place in November 2024, June 2024, and October 2023 where the Company used its non-invasive devices to collect pulse pressure waveform data from over 60 participants of varying gender, age, ethnicity and BMI. During each session, participants wore Movano Health’s wrist-worn device along with a hospital-grade FDA-cleared vital signs monitor with cuffed blood pressure measurements or utilizing arterial blood pressure data as the control. In mid-2025, the Company plans on executing an additional 100-150-person continuous blood pressure study using an arterial line, the results of which would help finalize the algorithm expected to be used in a future FDA pivotal trial.
According to DelveInsight’s “Vital Sign Monitoring Devices Market Report”, the global vital sign monitors market was valued at USD 7.59 billion in 2023, growing at a CAGR of 7.94% during the forecast period from 2024 to 2030, to reach USD 11.97 billion by 2030. The rising prevalence of chronic conditions like hypertension, diabetes, respiratory, and cardiovascular diseases is driving the demand for vital sign monitors. Additionally, this demand is bolstered by a global shift towards health-conscious behavior, with more consumers using wearable fitness devices to track vital signs daily. The integration of these monitoring capabilities into popular devices, along with advancements in product development, and the push towards digital health and telemedicine accelerated the adoption of vital sign monitors. As a result, the market is poised for rapid growth from 2024 to 2030.
IRB Granted Approval for PathMaker Neurosystems’ Department of Defense (DoD) Funded MyoRegulator® ALS Study
On February 04, 2025, PathMaker Neurosystems Inc., a clinical-stage company specializing in neuromodulation, announced that it received Institutional Review Board (IRB) approval to start enrolling participants in the U.S. Department of Defense-funded CALM study, “Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability.”
The clinical trial, focused on PathMaker’s MyoRegulator® investigational device for ALS treatment, was conducted at Beth Israel Deaconess Medical Center (BIDMC) in Boston, MA. The study was led by Seward Rutkove, M.D., Chair of the Department of Neurology at BIDMC and Professor at Harvard Medical School, along with Courtney McIlduff, M.D., MMSc, Assistant Professor of Neurology at Harvard Medical School and Director of the Multi-Disciplinary ALS Clinic at BIDMC. The CALM study (NCT06649955) was a single-site, open-label trial aimed at assessing the feasibility and safety of the MyoRegulator® device in ALS patients and providing early evidence of its effectiveness through clinical, neurophysiological, and biochemical measurements.
Nader Yaghoubi, M.D., Ph.D., PathMaker’s Co-Founder and CEO, stated, “We are pleased to announce IRB approval for the CALM study, which allows us to commence enrollments shortly. Given the mechanisms by which our technology work, we believe our non-invasive platform represents a new treatment modality that will be broadly applicable to ALS.”
PathMaker’s approach is based on the company’s proprietary multi-site direct current stimulation (Multi-Site DCS) platform, which modulates neurons and circuits associated with ALS through the suppression of motor neuron hyperexcitability and activation of protein degradation pathways. The MyoRegulator® device already been investigated in one early feasibility trial for ALS and three clinical trials for post-stroke spasticity.
According to DelveInsight’s “Neuromodulation Devices Market Report”, the neuromodulation devices market was valued at USD 5.71 billion in 2023, growing at a CAGR of 8.95% during the forecast period from 2024 to 2030 to reach USD 9.56 billion by 2030. The demand for neuromodulation devices is primarily driven by the growing prevalence of neurological disorders and the increasing number of patients suffering from chronic pain. Additionally, increasing research and development activities, along with collaborations among key players, are significantly contributing to market growth. The rising aging population further compounds this demand, as older adults are more susceptible to neurological conditions and chronic pain. These factors collectively position the neuromodulation devices market for positive growth during the forecast period from 2024 to 2030.
Aspen Medical Products Completed the Acquisition of Advanced Orthopaedics
On January 29, 2025, Aspen Medical Products, a leader in spine innovation for pain and mobility management, acquired Advanced Orthopaedics, a prominent manufacturer and supplier of bracing solutions and orthopedic soft goods. This strategic acquisition extended Aspen’s strength beyond spine care, broadening its global reach with a more comprehensive portfolio and customer-centric solutions. Together, Aspen and Advanced Orthopaedics offered an expansive product line designed to meet the evolving needs of distributors, channel partners, hospitals, DME suppliers, and retail outlets. The integration of Advanced Orthopaedics’ portfolio not only complemented Aspen’s existing product lines but also enhanced the overall value provided to customers.
“As Aspen continues to prioritize innovation, the acquisition of Advanced Orthopaedics gives us an additional platform to deliver success-driven solutions to our customers and partners. We will soon bring the same innovative approach to the global bracing and supports market that we have successfully implemented in spine for decades,” said Jim Cloar, Aspen’s Chief Executive Officer. “Based on our success with the UK-based Promedics acquisition in 2019, and now Advanced Orthopaedics, we have created a platform for rapid growth and a strong position in the global bracing market.”
“Aspen and Advanced coming together represents a significant shift in the bracing landscape – integrating two forward-thinking organizations dedicated to improving patient care,” said Scott Geist, Chief Executive Officer of Advanced Orthopedics. “We are excited to continue our journey as a joint organization that expands our ability to serve customers and distribution partners.”
According to DelveInsight’s “Orthopedic Braces and Support System Market Report”, the orthopedic braces and support systems market was valued at USD 4.63 billion in 2023, growing at a CAGR of 5.77% during the forecast period from 2024 to 2030 to reach USD 6.45 billion by 2030. The orthopedic braces and support systems market is growing significantly due to the rising number of trauma and accident cases that cause spinal injuries, the increase in prevalence of degenerative bone disorders such as osteoarthritis and rheumatoid arthritis, rising instances of sports-related injuries, and the increasing prevalence of neuromuscular disorders that are acting as major factors in escalating the demand for orthopedic braces and support systems during the forecast period from 2024 to 2030.
Surmodics Reported Successful Early Clinical Use of Pounce™ XL Thrombectomy System for Iliac and Femoral Arteries
On February 03, 2025, Surmodics, Inc., a leading provider of medical devices and in vitro diagnostic technologies to the healthcare industry, announced the successful early clinical use of its Pounce™ XL Thrombectomy System. The Pounce XL Thrombectomy System received U.S. Food and Drug Administration (FDA) 510(k) clearance in September 2024 and was in limited market release (LMR) at that time, with a full commercial launch planned after the completion of the LMR.
Surmodics’ Pounce Thrombectomy systems was designed for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature. The new Pounce XL Thrombectomy System was meant for use in vessels ranging from 5.5-10 mm in diameter, typical of iliac and femoral arteries. It complemented the Pounce and Pounce LP Thrombectomy Systems, which were used for 3.5-6 mm and 2-4 mm vessels, respectively.
“The Pounce XL Thrombectomy System removed a significant amount of chronic material during our first use,” said Dr. Rizzoni. “In that respect, its performance was right in line with our experience using the Pounce and Pounce LP Systems.”
“We’re excited about the positive feedback we’ve received from early users of the Pounce XL System,” said Gary Maharaj, President and Chief Executive Officer of Surmodics. “The addition of this larger-profile device to the Pounce Thrombectomy Platform fulfills our goal of providing physicians a standalone solution for rapid removal of acute or chronic peripheral arterial clot throughout the lower extremity. With hospitals under growing pressure to reduce costs, we believe the standalone Pounce Thrombectomy Platform may help reduce the need for hospitalizations and follow-up procedures.”
According to DelveInsight’s “Thrombectomy Devices Market Report”, the global thrombectomy devices market is poised for significant growth, projected to achieve a remarkable CAGR of 5.24% during the forecast period from 2024 to 2030. The demand for thrombectomy devices is being boosted by the increasing prevalence of lifestyle disorders such as low blood pressure, diabetes, obesity, age, and others. Further, the increasing prevalence of venous thromboembolism, cardiovascular diseases, cancer, and neurological diseases such as ischemic stroke, hemorrhagic stroke, and peripheral diseases, among others will lead to the formation of blood clots, thereby leading to the increased demand for thrombectomy devices.
