Sonomotion Announced FDA Clearance for its Break Wave™ Lithotripsy Device for Treatment of Kidney Stones
On January 21, 2026, SonoMotion, a venture-backed medical device company focused on developing non-invasive solutions for kidney stone treatment, announced that it had received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Break Wave lithotripsy device. Break Wave used low-pressure focused ultrasound to fragment kidney stones by generating standing stress waves within the stone under real-time ultrasound image guidance. The procedure was completely non-invasive and did not require anesthesia, enabling patients to drive themselves to and from the procedure and to eat and drink normally beforehand.
The company was developing and commercializing a comprehensive kidney stone treatment platform comprising multiple devices, including Break Wave and Stone Clear™. Together, these devices offered an anesthesia-free, non-invasive treatment pathway, in which Break Wave fragmented kidney stones while Stone Clear facilitated the clearance of residual fragments following lithotripsy. Stone Clear had received FDA 510(k) de novo clearance in October 2024.
“Break Wave provides a new option for the safe and effective treatment of kidney stones that can be performed in nearly any healthcare setting and does not require a ureteral stent,” said Helena Chang, MD, Kaiser Permanente. “Patients with symptomatic obstructing ureteral stones can move immediately to treatment, saving weeks of pain and discomfort trying to pass a stone. Additionally, patients with asymptomatic kidney stones have an option to treat stones before they cause a painful event.”
As per DelveInsight’s “Lithotripsy Devices Market Report,” the Lithotripsy devices market was valued at USD 1.39 billion in 2023, growing at a CAGR of 4.32% from 2024 to 2030 to reach USD 1.78 billion by 2030. The lithotripsy devices market is growing significantly due to the rising prevalence of urolithiasis, technological advancements in product development, increased risk of end-stage renal failure, and rising awareness of the procedure, which is expected to escalate the demand for lithotripsy devices during the forecast period from 2024 to 2030.
Aidoc Secured FDA Clearance for Healthcare’s First Comprehensive Foundation Model AI
On January 22, 2026, Aidoc, a pioneer and global leader in clinical AI, announced that the U.S. Food and Drug Administration (FDA) had cleared the healthcare industry’s first comprehensive AI triage solution, enabling health systems to identify critical findings earlier and reduce delays in patient flow amid Emergency Department (ED) crowding and imaging backlogs. The clearance was enabled by CARE™, Aidoc’s self-developed AI foundation model. The solution combined 11 newly cleared indications with three previously cleared indications into a single, unified workflow, allowing triage across a broad range of acute findings during periods of high clinical demand.
Emergency Departments continued to face sustained pressure from rising patient volumes and growing imaging backlogs, resulting in crowding and delays. Traditional ED imaging workflows relied on first-in, first-out reading, whereas Aidoc’s comprehensive body CT triage approach provided a safety net that surfaced acute findings earlier, supporting timely clinical decision-making and improved patient throughput.
This safety net also extended to ambulatory care settings, where unexpected critical findings could arise from routine imaging studies delayed by backlogs. By flagging these cases earlier, the solution helped reduce patient safety risks and supported timely clinical follow-up.
The FDA clearance validated Aidoc’s foundation-model strategy for delivering comprehensive clinical AI at scale and marked the first FDA clearance of a double-digit set of acute indications powered by a single foundation model. The solution demonstrated substantially improved signal quality, achieving approximately an order-of-magnitude reduction in false alerts compared with leading single-condition AI solutions. In the FDA-reviewed pivotal study, the 11 indications achieved mean sensitivities of 97% (up to 98.5%) and mean specificities of 98% (up to 99.7%), meeting the safety, quality, and reliability requirements for real-world clinical adoption.
The comprehensive body CT triage solution was delivered through Aidoc aiOS™, the company’s enterprise AI operating system. aiOS supported foundation-model–scale deployment through data normalization, continuous performance monitoring, and built-in governance, enabling health systems to deploy and manage multi-condition clinical AI without re-architecting existing infrastructure. With more than 100 million patient cases analyzed, aiOS had become the most widely deployed clinical AI platform in healthcare.
“The ability to bring key acute conditions together into a single workflow is a fundamental shift in how radiology departments operate,” said Heidi Beilis, MD, FACR, Chief Medical Officer of Diagnostics at WellSpan Health. “We’ve integrated numerous AI tools across our imaging operations, but this comprehensive triage solution can directly address core challenges in the field, including how we manage workflow, accelerating time-to-diagnosis for acute conditions and, ultimately, improving patient outcomes.”
As per DelveInsight’s “Artificial Intelligence (AI) In Medical Imaging Market Report,” the global artificial intelligence in medical imaging market is expected to increase from USD 1,673.03 million in 2024 to USD 13,181.93 million by 2032, growing at a CAGR of 29.48% during the forecast period from 2025 to 2032. The global artificial intelligence in medical imaging market is being driven by the rising prevalence of chronic diseases such as cancer, cardiovascular disorders, and neurological conditions, which increase demand for accurate and efficient diagnostics. Government initiatives and funding are promoting healthcare digitization and AI adoption, while key players are investing in product development and strategic collaborations to enhance imaging solutions. Rapid advancements in deep learning, machine learning, and computer vision are further improving diagnostic accuracy, workflow efficiency, and predictive capabilities, collectively accelerating market growth across regions.
BD and Ypsomed Expanded Partnership to Address Rapidly Growing Biologics Market
On January 21, 2026, BD (Becton, Dickinson and Company) and Ypsomed announced that they had strengthened their collaboration by developing a 5.5 mL version of the BD Neopak™ XtraFlow™ Glass Prefillable Syringe. The newly developed syringe is fully compatible with Ypsomed’s YpsoMate® 5.5 autoinjector platform, expanding treatment options for pharmaceutical companies and patients who require large-volume subcutaneous self-injections.
The 5.5 mL BD Neopak™ XtraFlow™ Glass Prefillable Syringe incorporated BD’s advanced delivery technologies, including a shorter 8-millimeter needle and thinner-wall cannulas, to support the administration of higher-volume, higher-viscosity medicines. These design enhancements were intended to improve injection times and optimize flow performance, addressing common challenges associated with large-volume biologics and enabling drug developers to move beyond the constraints of conventional syringe formats.
Patrick Jeukenne, Worldwide President of BD Pharmaceutical Systems, stated that the next-generation syringe directly addressed the growing demand for patient-friendly solutions in the high-dose biologics segment. He noted that by combining BD’s expertise in drug delivery with Ypsomed’s leadership in autoinjector technologies, the collaboration aimed to simplify self-injection for patients managing complex and chronic conditions.
Large-volume subcutaneous injections exceeding 1 mL had become increasingly common in therapeutic areas such as oncology, autoimmune disorders, rare diseases, and metabolic conditions. Ypsomed’s YpsoMate® 5.5 autoinjector, which was introduced in 2022, was developed to address this need, offering an ergonomic design, intuitive two-step activation, and clear user feedback to enhance patient confidence and ease of use.
The newly developed BD Neopak™ XtraFlow™ 5.5 mL Glass Prefillable Syringe was designed to further enhance the YpsoMate® 5.5 platform by maximizing flow efficiency and reducing injection time, factors that have become increasingly critical as dosing volumes and drug viscosities continue to rise.
“Ypsomed and BD, in close collaboration with our pharmaceutical partners, are expanding the subcutaneous delivery design space to accommodate high-dose therapies, both volume and viscosity,” said Ulrike Bauer, Chief Business Officer at Ypsomed. “These partnerships are critical as we jointly drive the future of high-dose biopharmaceutical delivery.”
As per DelveInsight’s “Biologics Market Report,” the global biologics market was valued at USD 333.10 billion in 2023, growing at a CAGR of 9.59% during the forecast period from 2024 to 2030, in order to reach USD 577.03 billion by 2030. The biologics market is witnessing a positive market growth owing to factors such as the rising prevalence of autoimmune disorders, such as rheumatoid arthritis, the rising prevalence of cancers, increasing prevalence of infectious diseases, the increasing cases of genetic disorders, and increasing product development activities with latest innovation with respect to biologics, among others.
Omnia Medical Announced Commercial Launch of FDA-Cleared PsiF DNA™ System
On January 20, 2026, Omnia Medical, a medical technology company focused on developing surgical solutions for spine and interventional pain physicians, announced the commercial launch of its FDA-cleared PsiF DNA™ Sacroiliac Joint Stabilization System.
The company received U.S. Food and Drug Administration (FDA) 510(k) clearance for the PsiF DNA™ System in May 2025. Following the clearance, Omnia Medical conducted an initial alpha launch to obtain physician feedback and further refine its commercial strategy. The positive outcome of this early rollout enabled the company to move forward with a broader market launch.
The PsiF DNA™ System was indicated for sacroiliac joint fusion in patients with conditions such as degenerative sacroiliitis and sacroiliac joint disruptions. Designed for a minimally invasive posterior surgical approach, the system aimed to stabilize the sacroiliac joint and promote fusion. During implantation, the PsiF DNA™ device was inserted through the ilium, crossed the sacroiliac joint, and anchored into the sacrum, a configuration intended to enhance fixation strength and reduce the risk of implant migration. Bone graft material was placed within the implant to support bone growth and fusion following surgery.
A distinguishing feature of the system was its double-helix design, which utilized autograft bone from both the ilium and sacrum to support arthrodesis and provide durable, long-term stabilization of the sacroiliac joint.
“The FDA clearance and commercial launch of PsiF DNA™ represent important milestones for Omnia Medical,” said Abigail Mann, Project Manager, SI Technologies. “They reflect our commitment to delivering physician-driven technologies that support procedural consistency while addressing the complexity of SI joint pathology.”
According to DelveInsight’s “Spinal Fusion Devices Market Report”, the spinal fusion devices market was valued at USD 7,139.71 million in 2024, growing at a CAGR of 5.31% during the forecast period from 2025 to 2032 to reach USD 10,762.88 million by 2032. The spinal fusion devices market is experiencing steady growth, driven by the rising instances of spinal disorders along with the growing global prevalence of chronic pain. Additionally, conditions such as degenerative disc disease, spondylolisthesis, and spinal stenosis are becoming increasingly common, particularly among the aging population. The surge in road traffic accidents further highlights the urgent need for effective spinal fusion solutions to restore mobility and reduce long-term disability. Additionally, the increase in product development activities among key market players is further driving the overall market for spinal fusion devices. Collectively, these factors are anticipated to fuel the expansion of the spinal fusion devices market over the forecast period from 2025 to 2032.
Kardium Announced Publication of PULSAR Pivotal Trial Results in JACC
On January 21, 2026, Kardium Inc., an emerging leader in advanced solutions for atrial fibrillation, announced that the results of the PULSAR clinical trial had been published in the Journal of the American College of Cardiology (JACC). The landmark study evaluated Kardium’s Globe® Pulsed Field System for the treatment of paroxysmal atrial fibrillation (PAF).
The multicenter pivotal trial demonstrated that the Globe® System achieved durable pulmonary vein isolation (PVI) in 95% of treated veins with a single pulsed field application, while maintaining a 0% rate of device-related primary safety events. At 12-month follow-up, 78% of patients remained free from atrial arrhythmias, highlighting the system’s effectiveness in treating drug-refractory PAF.
The study enrolled 183 patients across leading clinical centers in North America and Europe, with procedures showing high efficiency in mapping, ablation, and overall treatment times. Importantly, the trial confirmed the strong safety profile of the technology, reporting a 0% primary device-related safety event rate throughout the study period.
“The Globe Pulsed Field System has the potential to transform how we treat atrial fibrillation by delivering durable pulmonary vein isolation with remarkable efficiency and safety,” said Dr. Vivek Reddy, Principal Investigator of the trial. “These results show that this technology can make a real difference for patients, offering them better outcomes and a safer path to long‑term relief from arrhythmias.”
“The publication of the PULSAR pivotal trial results in JACC is a tremendous validation of the safety, efficacy and efficiency of the Globe System. At Kardium, we are committed to delivering the most advanced system for the treatment of atrial fibrillation,” said Kevin Chaplin, Chief Executive Officer of Kardium.
According to DelveInsight’s ”Ablation Devices Market Report,” the global ablation devices market size is expected to increase from USD 8,090.31 million in 2024 to USD 15,347.69 million by 2032, growing at a CAGR of 8.38% during the forecast period from 2025 to 2032. The market for ablation device solutions is primarily driven by the rising prevalence of chronic diseases such as cancer and cardiovascular diseases, as well as by global technological advancements.
Hyperfine Announced NEURO PMR Study Results Showing High Diagnostic Value and Superior Patient Experience in Neurology Clinics
On January 20, 2026, Hyperfine, Inc. (Nasdaq: HYPR), a health technology company known for pioneering the first FDA-cleared AI-powered portable MRI system for brain imaging, announced the results of its NEURO PMR study, which were presented by Dr. Laszlo Mechtler at the American Society of Neuroimaging (ASN) Annual Meeting held in San Juan, Puerto Rico, on January 16, 2026.
The NEURO PMR (Neurological Evaluation in the Office with Portable MR) study was the first prospective, multicenter, real-world investigation to assess the clinical utility and patient experience of portable MRI compared with standard-of-care MRI in outpatient neurology clinics. Two clinical sites, the DENT Neurologic Institute and Texas Neurology, enrolled 125 patients presenting with commonly encountered neurological conditions, including headaches, dementia, multiple sclerosis follow-up, and tumor surveillance. Each patient underwent brain imaging using both the portable Swoop® system (0.064T) and a conventional high-field MRI system, primarily 3T, enabling direct comparison between modalities.
The study showed that portable MRI achieved 92% concordance with standard MRI in detecting the presence or absence of intracranial pathology during blinded reviews conducted by independent neuroradiologists. When unblinded paired image reviews incorporating clinical history were performed, concordance increased to 98%, as assessed by a neurologist and a neuroimager. Patients reported a strong preference for portable MRI, indicating they were four times more likely to choose it over standard MRI. Across all patient experience metrics, including comfort, anxiety, claustrophobia, noise, and overall satisfaction, portable MRI was rated superior to conventional MRI (p<0.0001).
In addition, trained clinical staff successfully operated the portable MRI system within neurology offices without the need for dedicated MRI technologists, demonstrating a safe, simplified workflow suitable for outpatient clinical settings.
“From a clinical perspective, I have been impressed by the image quality delivered by the Swoop® system. The study results give me confidence in its ability to detect structural abnormalities encountered in routine neurological care,” said Laszlo Mechtler, MD, Chief Medical Officer at DENT Neurologic Institute and Principal Investigator of the NEURO PMR study. “Portable MRI represents a groundbreaking innovation for neurology clinics, complementing tools like EEG and ultrasound to expand diagnostic capabilities at the point of care. Neuroimaging is not merely an ancillary test but an extension of the neurological examination—expanding access to this technology will put imaging back into the neurologist’s hands and meaningfully improve the quality of patient care.”
According to DelveInsight’s “Magnetic Resonance Imaging (MRI) Devices Market Report”, the magnetic resonance imaging devices market was valued at USD 8,207.06 million in 2024, growing at a CAGR of 6.54% during the forecast period from 2025 to 2032 to reach USD 13,553.33 million by 2032. The rising prevalence of various chronic disorders, such as cardiovascular diseases, cancer, and neurological conditions, is fueling the demand for precise diagnostic tools like MRI, which offers superior imaging capabilities for soft tissues and organs. Additionally, the increasing awareness and the emphasis on early diagnosis of chronic disease are encouraging patients and healthcare providers to adopt MRI for timely intervention. Furthermore, technological advancements play a crucial role in boosting the MRI market, with innovations such as high-field and open MRI systems, functional MRI (fMRI), and faster scan times improving the accuracy, comfort, and efficiency of the imaging process. Collectively, these factors are expected to increase global demand for magnetic resonance imaging devices during the forecast period from 2025 to 2032.
