As per DelveInsight’s “Cancer Diagnostics Market Report”, the global cancer diagnostics market was valued at USD 125.13 billion in 2023, growing at a CAGR of 9.43% during the forecast period from 2024 to 2030, to reach USD 214.88 billion by 2030. The increase in demand for cancer diagnostics products and services is predominantly attributed to the spike in cancer cases reported worldwide. In addition, growing manufacturers’ focus to develop advanced cancer diagnostic products, the establishment of various cancer diagnostic labs, and rising government initiatives to raise awareness regarding early detection and management of cancer among patients, and others are anticipated to drive the global cancer diagnostics market during the forthcoming years.
Johnson & Johnson MedTech Received IDE Approval for OTTAVA™ Robotic Surgical System
On November 12, 2024, Johnson & Johnson MedTech, a global leader in cardiovascular, orthopaedic, surgery, and vision solutions, announced that the U.S. Food & Drug Administration (FDA) approved the OTTAVA™ robotic surgical system investigational device exemption (IDE), allowing the clinical trial to begin at U.S. sites. The company then prepared clinical trial sites to receive OTTAVA systems, enrolled patients, and initiated surgical cases.
Johnson & Johnson MedTech built on its global portfolio of surgical technologies to advance OTTAVA and supported surgical teams and hospitals in providing more patients with the benefits of robotic surgery. The system was designed to address unmet needs in robotic surgery while fostering choice and competition in an underpenetrated and high-growth market.
“We are bringing the best of J&J MedTech’s surgery expertise to the OTTAVA system and taking a holistic view of the science of surgery to enable new experiences across all surgical modalities in service of patients around the world,” said Hani Abouhalka, Company Group Chairman, Surgery, Johnson & Johnson MedTech. “Meeting this milestone brings us a step closer to delivering on our promise to make technology more human, care more adaptive, and people more connected so that surgery works better for everyone.”
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, as well 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.
Organogenesis Reports Positive Interim Analysis of Second Phase 3 Clinical Trial of ReNu for Knee Osteoarthritis
On November 11, 2024, Organogenesis Holdings Inc., a leading regenerative medicine company focused on developing, manufacturing, and commercializing product solutions for the Advanced Wound Care and Surgical & Sports Medicine markets, announced the favorable outcome of the interim analysis of its second Phase 3 randomized control trial of ReNu, a cryopreserved amniotic suspension allograft (ASA) for managing symptoms associated with knee osteoarthritis (OA).
The pre-specified interim analysis was conducted on 50% of the planned 474 patients with moderate to severe knee OA (Kellgren-Lawrence [KL] severity grade 2 to grade 4), focusing on the 6-month primary endpoint for potential sample size re-estimation. The independent Data Monitoring Committee (DMC) for the trial provided directional guidance on the results of the interim analysis, rigorously maintaining all aspects of study blinding. The DMC recommended that the trial proceed without modification and without an increase in sample size. Additionally, the DMC found the safety data to be consistent with ReNu’s known safety profile.
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.
“We have passed another critical milestone in the ReNu development program,” said Patrick Bilbo, Chief Operating Officer of Organogenesis. “We are pleased with the outcome of the interim analysis which indicates the study is in the favorable zone and consistent with the assumptions for the statistical plan and efficacy expectations.”
According to DelveInsight’s “Bone Grafts and Substitutes Market Report”, the bone grafts and substitutes market was valued at USD 3.02 billion in 2023, growing at a CAGR of 6.06% during the forecast period from 2024 to 2030 to reach USD 4.29 billion by 2030. The bone grafts and substitutes market is experiencing significant growth, owing to the rising incidence of trauma cases that are often a result of road traffic accidents, widespread instances of degenerative conditions like osteoarthritis and rheumatoid arthritis, among others that are acting as key factors driving the bone grafts and substitutes market during the forecast period from 2024 to 2030.
LivaNova OSPREY Clinical Study Meets Primary Safety and Efficacy Endpoints
On November 11, 2024, LivaNova PLC, a market-leading medical technology company, announced that it met the primary endpoints for its OSPREY randomized controlled trial (RCT), which evaluated the treatment of obstructive sleep apnea using targeted hypoglossal nerve stimulation. Along with its safety endpoints, the RCT achieved statistical significance in the primary endpoint responder rates between the treatment arm and the sham arm for the LivaNova aura6000™ System. The aura6000 is an implantable hypoglossal neurostimulator intended for adult patients with moderate to severe obstructive sleep apnea (OSA).
In the OSPREY study, reductions in the apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) were analyzed as part of the study’s secondary endpoints. Comparing median values from baseline to six months with therapy (assessed at the seven-month follow-up visit), subjects in the device stimulation group experienced significant reductions in these endpoints:
- AHI was reduced by 66.2%, with the median at baseline of 34.3 decreasing to 11.6 at six months.
- ODI was reduced by 63.3%, with the median at baseline of 34.9 decreasing to 12.8 at six months.
Once the six-month results analysis is completed, LivaNova will submit the OSPREY clinical data to the U.S. Food and Drug Administration (FDA) as part of its premarket approval submission for the aura6000 System.
“The study results reinforce our belief that targeted hypoglossal nerve stimulation provides a compelling alternative for patients with obstructive sleep apnea. The significant reductions in AHI and ODI achieved after only six months of therapy gives us strong evidence of this technology’s potential at 12 months and beyond,” said Vladimir Makatsaria, Chief Executive Officer of LivaNova. “I would like to thank the patients and physicians who have participated in OSPREY to date. We look forward to evaluating the full results as patients complete 12 months of therapy.”
According to DelveInsight’s “Spinal Cord Stimulators Market Report”, the global spinal cord stimulators market size was valued at USD 2.25 billion in 2023, growing at a CAGR of 8.70% during the forecast period from 2024 to 2030 to reach USD 3.72 billion by 2030. The demand for spinal cord stimulators is primarily attributed to the growing number of patients with chronic pain, and neuropathic pain in the shoulder, legs, and knee. The technologically advanced devices that are non-invasive, eliminate targeted pains, and cause a reduction in patient discomfort, with no side effects are likely responsible for a boost in the global Spinal Cord Stimulators market growth. Moreover, favorable government regulations for commercialization and launching products in the market and the rising geriatric population are some of the factors responsible for propelling the growth of the spinal cord stimulators market.
Hyperfine Announced European Launch of the Latest Generation Swoop® System a Portable Magnetic Resonance (MR) Brain Imaging System With CE Approval
On November 7, 2024, Hyperfine, Inc., the groundbreaking health technology company that redefined brain imaging with the first FDA-cleared portable magnetic resonance (MR) brain imaging system Swoop® system, announced the launch of its latest generation of AI-powered Swoop® system software under the European Medical Device Regulation (MDR, EU No. 2017/745), following CE approval. This marked a significant step in positioning Hyperfine for a broad European launch of the Swoop® Portable MR Imaging® system, enabling faster, and high-quality MR brain imaging to support critical diagnostic decisions across diverse healthcare settings.
“We are thrilled to announce CE approval for the latest generation of AI-powered software for the Swoop® system, marking a pivotal step toward making advanced brain imaging technology accessible across the globe,” shared David Castiglioni, Hyperfine Chief Commercial Officer. “With a broad international distribution network in place and the latest software being CE-approved, we are well positioned for commercial expansion. We are committed to transforming healthcare through innovative, cost-effective solutions that address long-standing barriers to MRI access, and we look forward to expanding our collaboration with European healthcare leaders and providers to improve brain MRI access and patient outcomes across the region.”
According to DelveInsight’s “PET-MRI Systems Market Report”, the global PET-MRI systems market is estimated to grow at a CAGR of 5.71% during the forecast period from 2024 to 2030. The PET-MRI systems market is observing substantial market growth owing to the increasing prevalence of neurological disorders such as Alzheimer’s and other dementias, strokes, migraine, and other headaches, multiple sclerosis, Parkinson’s disease, neurological infections, brain tumors, and the rising prevalence of various cancers around the globe. Further, the escalating burden of the geriatric population, extensive research and development activities employing PET-MRI systems, increasing approval activities by regulatory authorities for devices, the surging new device launches, and the presence of key players in the market, among others will create a requisite for PET-MRI systems in the market. Therefore, the PET-MRI systems market is estimated to grow at a substantial CAGR during the forecast period from 2024 to 2030.
Nihon Kohden Enhanced Neurological Treatment Through The Acquisition of Ad-Tech Medical Instrument Corporation
On November 12, 2024, Nihon Kohden, a global leader in medical device innovation for high-precision patient monitoring and diagnostics, announced the acquisition of a 71.4% stake in NeuroAdvanced Corp., the parent company of Ad-Tech Medical Instrument Corporation (Ad-Tech), a trusted provider of specialized electrodes for epilepsy treatment and neurodiagnostic procedures. This acquisition further solidified Nihon Kohden’s position as an industry leader by combining its established expertise in EEG systems with Ad-Tech’s specialized intracranial electrodes enhancing the company’s ability to address complex neurological conditions, including drug-resistant epilepsy.
By merging its six decades of deep-rooted expertise in neurology diagnostics with Ad-Tech’s best-in-class consumables, Nihon Kohden positioned itself to deliver even more impactful and integrated care. With both companies already present in a majority of the top 50 U.S. hospitals, the acquisition created added synergy and facilitated ease of adoption for clinicians and hospital systems nationwide.
“This acquisition represents a pivotal step in advancing critical solutions for epilepsy care,” said Roy Sakai, President of Nihon Kohden America. “By uniting our strengths, we’re enhancing our ability to provide end-to-end support for epilepsy—from accurate diagnosis to advanced interventions.”
According to DelveInsight’s “Neurological Diagnostic and Monitoring Equipment Market Report”, the neurological diagnostic and monitoring equipment market was valued at USD 11.81 billion in 2023, growing at a CAGR of 6.66% during the forecast period from 2024 to 2030, and will reach USD 17.33 billion by 2030. The market for neurological diagnostic and monitoring equipment is experiencing robust growth driven by several key factors. First, the increasing prevalence of neurological disorders, such as brain cancer, epilepsy, Alzheimer’s disease, and Parkinson’s disease, underscores a growing demand for advanced diagnostic tools that can accurately assess and monitor these conditions. Secondly, the rising incidence of traumatic brain injuries (TBIs) globally has further bolstered the demand for neurological diagnostic equipment. Prompt and accurate diagnosis of TBIs is crucial for initiating timely treatment and minimizing long-term complications, driving the adoption of sophisticated monitoring technologies in emergency and critical care settings. Additionally, the government initiatives not only contribute to increased patient awareness and engagement but also foster a proactive approach towards healthcare, thereby stimulating the uptake of diagnostic and monitoring equipment. Furthermore, the regulatory support not only ensures the safety and efficacy of these devices but also encourages healthcare providers to invest in state-of-the-art equipment that enhances diagnostic accuracy and patient care outcomes thereby boosting the overall market during the forecast period from 2024 to 2030.
