Eric Smith, MIMEDX Senior Vice President, Marketing & International, added, “HELIOGEN—named for the product’s triple helical collagen structure—is an exciting addition to our portfolio and provides another tool to help our customers manage complex wounds. With a solid foundation of initial case studies and real-world evidence, we are excited for customers in various surgical settings to build on this evidence and realize improved outcomes for their patients.”
As per DelveInsight’s “Skin Grafting Devices Market Report”, the global skin grafting devices market is estimated to grow at a CAGR of 7.31% during the forecast period from 2024 to 2030. The demand for skin grafting devices is primarily being boosted by the increasing wounds such as deep burns, skin cancer or reconstructive surgeries, skin cancer, increasing prevalence of burn injuries, leg ulcers including pressure and diabetic foot ulcers and skin infections, technological advancements in dermatomes such as the development of electric and air dermatomes, rising product launch and approvals, among others are thereby contributing to the overall growth of the skin grafting devices market during the forecast period from 2024 to 2030.
DocGo Launched Mobile X-ray Program in Partnership with MinXray
On August 05, 2024, DocGo Inc., a leading provider of technology-enabled mobile health services, announced the launch of a groundbreaking mobile X-ray program in partnership with MinXray. This program, introduced in New York City, aims to provide rapid and accessible chest X-rays for vulnerable populations, helping to identify active Tuberculosis (TB) cases.
As TB cases continue to rise in cities across the US, this program serves as a timely response to an increasing public health challenge. DocGo’s mobile units, equipped with MinXray’s advanced ultra-portable, battery-powered x-ray system, provide chest x-rays for patients who test positive for TB through blood tests. The program utilizes third-party artificial intelligence technology to rapidly analyze X-ray images and prioritizes likely cases for immediate review by a board-certified radiologist. This approach ensures that individuals with active TB receive quick confirmation and appropriate referrals for further care.
“DocGo is on a mission to make healthcare accessible and immediate for those who need it most,” said Lee Beinstock, CEO of DocGo. “By integrating our extensive mobile health infrastructure and partnering with leaders in x-ray and AI technology, we can provide timely x-ray screenings and diagnosis. We’re pleased to launch this program to help reduce the spread of TB in our communities, and look forward to expanding this mobile health program for a range of diagnostic applications.”
The program is designed to provide fast and efficient services, which is crucial for effectively managing and treating TB, especially among high-risk populations.
Jeanne Walter, VP of Marketing & Sales at MinXray, added, “MinXray is committed to providing reliable and portable x-ray solutions that can be deployed anywhere, and we’re pleased to partner with DocGo on this innovative program.”
In the future, DocGo plans to expand this mobile X-ray program to more locations across New York City and offer this flexible service to additional municipalities and partners. The goal is to provide X-ray diagnostics directly to patients with limited mobility and to help treat vulnerable populations.
According to DelveInsight’s “X-ray Devices Market Report”, the global X-ray devices market was valued at USD 10.57 billion in 2023, growing at a CAGR of 8.36% during the forecast period from 2024 to 2030 to reach USD 17.10 billion by 2030. The demand for X-ray devices is primarily being boosted by the rising incidence observed in different types of cancer cases and rising prevalence observed in patients affected with cardiovascular diseases, rise in the number of orthopedic disorders such as injuries and diseases affecting the musculoskeletal system in humans, and technological advancements in the X-Ray devices arena which are expected to increase the product demand thereby contributing in the growth of the X-Ray devices market during the forecast period.
Labcrop Received FDA De Novo Marketing Authorization for PGDx elioTM plasma focus Dx
On August 02, 2024, Labcorp, a global leader in laboratory services, announced that it received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for PGDx elio™ plasma focus Dx. This is the first and only kitted liquid biopsy test available for pan-solid tumors in the industry.
“The launch of PGDx elio plasma focus Dx represents a landmark expansion of Labcorp’s suite of precision oncology solutions,” said Shakti Ramkissoon, M.D., Ph.D., MBA, vice president, medical lead for oncology at Labcorp. “This latest liquid biopsy test offers laboratories and oncologists a convenient, cost-effective and highly targeted tumor-profiling solution that spans a wide range of solid-tumor types – particularly when tumor tissue is limited or unavailable. When paired with PGDx elio tissue complete, Labcorp now offers laboratories access to tissue and liquid genomic-profiling assays that operate on the same instrument, enabling seamless integration of these precision oncology products into routine laboratory workflows. The ability to test tissue or liquid will provide critical data and insights needed to inform more personalized treatments and care plans for patients.”
PGDx elio plasma focus Dx is a qualitative next-generation sequencing-based in vitro diagnostic device that employs targeted high-throughput hybridization-based capture technology. It detects single nucleotide variants (SNVs), insertions and deletions (indels) in 33 genes, copy number amplifications (CNAs) in five genes, and translocations in three genes. The assay focuses on guideline-recommended biomarkers to provide more accurate clinical assessments and is paired with automated bioinformatics for faster results. This solution enhances oncologists’ ability to make timely treatment decisions when combined with other laboratory and clinical findings and also supports sample and data ownership.
As per DelveInsight’s “Biopsy Devices Market Report”, the global biopsy devices market is anticipated to grow at a CAGR of 5.1% during the forecast period from 2024 to 2030. The biopsy device market is witnessing positive growth owing to various factors such as the increasing prevalence of breast cancer, the rise in the geriatric population, the rising incidence of lung cancer, and rising technological advancements to the product offerings. Therefore, the market for biopsy devices is estimated to grow during the biopsy devices market forecast period from 2024 to 2030.
Inspire Medical Systems, Inc. Announced FDA Approval of the Inspire V System
On August 02, 2024, Inspire Medical Systems, Inc., a medical technology company specializing in innovative, minimally invasive solutions for patients with obstructive sleep apnea (OSA), announced that the FDA approved the Inspire V therapy system. This system includes the next-generation neurostimulator, along with a Bluetooth® patient remote and physician programmer.
“We are thrilled to announce the FDA approval of our next-generation Inspire neurostimulation system,” said Tim Herbert, Chairman and Chief Executive Officer of Inspire Medical Systems. “The FDA approval marks a key milestone for the future of Inspire therapy and reinforces the many years of hard work by our team members.”
The company is concentrating on operational readiness, which involves product manufacturing and building inventory levels to support a comprehensive commercial launch in the United States. They are planning for a soft launch in late 2024, followed by a full launch in 2025.
As per 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.
Alcyone Therapeutics Announced Continued Enrollment Approval from the FDA of the PIERRE Pivotal IDE Clinical Study of the ThecaFlex DRXTM System for Administration of Nusinersen
On July 31, 2024, Alcyone Therapeutics Inc. (Alcyone), a clinical-stage biotechnology company at the forefront of next-generation precision genetic therapies and delivery solutions for complex neurological conditions, announced that the U.S. Food and Drug Administration (FDA) had approved the continuation of enrollment for the PIERRE study. This study aims to assess the safety and effectiveness of the ThecaFlex DRx™ subcutaneous port and intrathecal catheter system for chronic intrathecal access, CSF aspiration, and the delivery of SPINRAZA® (nusinersen) in SMA patients, offering an alternative to repeat lumbar punctures.
As previously announced, the PIERRE IDE trial was designed to enroll up to 90 SMA patients, aged 3 years and older, and was conducted in two stages. The first stage, which involved enrolling and implanting 10 SMA patients, administering nusinersen, and monitoring them for 30 days, had been completed. During this stage, all attempts to aspirate and infuse through the ThecaFlex port were successful, with no infections or device-related adverse events reported. Following a review of the data from this initial stage, the FDA approved the continuation of the trial, allowing the enrollment of an additional 80 SMA patients across up to 30 centers in the U.S. and Europe.
From the experience with the first 10 SMA patients in the trial, the implantation of ThecaFlex took between one and two hours, depending on the patient’s spinal complexity. Most SMA patients were discharged from the hospital within 24 hours of implantation. After implantation, the infusion procedure was usually carried out in a standard exam room rather than a specialized setting. The entire infusion procedure lasted less than 30 minutes, with the actual nusinersen subcutaneous infusion taking under 10 minutes.
“As we approach the next stage of the PIERRE IDE study, we will continue to evaluate the safety and efficacy of the ThecaFlex system to help patients with spinal muscular atrophy receive the SPINRAZA® (nusinersen) therapy,” said Dr. Scellig Stone, M.D., Ph.D., FRCSC the Boston Children’s Hospital primary investigator for the PIERRE study. “The initial data and patient feedback are optimistic and a key first step toward developing a less invasive, more accessible procedure that may improve the overall dosing experience for SMA patients and may help optimize hospital resources.”
“We were pleased to receive the recommendation from the independent data monitoring safety committee to continue enrollment without any changes to the PIERRE study protocol as well as the FDA’s subsequent approval to continue enrollment,” said Dr. Kathrin Meyer, Ph.D., Alcyone’s Chief Scientific Officer and Head of Research & Development. “This represents a tangible step toward our goal of substantially improving treatment experience for patients requiring repeat intrathecal delivery of medications for the treatment of neurological disorders.”
The PIERRE study is currently evaluating the potential clinical benefits of the ThecaFlex DRx System, which may include: (a) facilitating routine subcutaneous administration of ASO (antisense oligonucleotide) therapies to the cerebrospinal fluid, and (b) decreasing the need for anesthesia and radiation exposure compared to repeated lumbar punctures for SPINRAZA infusion in SMA patients.
“For those who currently require anesthesia and radiographic guidance for delivery of nusinersen, which exposes them to radiation, ThecaFlex could shift administration from a specialized visit to an exam room setting,” said Dr. Michael Muhonen, M.D. at the Children’s Hospital of Orange County in California. “I look forward to the continued enrollment of the study and future learnings from the patient therapy administration experience with this innovative device.”
According to DelveInsight’s “Chest Drainage Catheters Market Report”, the global chest drainage catheters market is estimated to grow at a CAGR of 4.78% during the forecast period from 2024 to 2030. The demand for chest drainage catheters is primarily being boosted by the increasing patient population suffering from various cardiovascular diseases (CVDs) requiring surgeries, the increasing burden of spontaneous pneumothorax, the growing preference for minimally-invasive surgeries, continuous innovation in product development, and others, thereby contributing to the overall growth of the chest drainage catheters market during the forecast period from 2024 to 2030.
Lunit’s AI for Tuberculosis Detection Toped in 12-Product Comparative Study
On August 06, 2024, Lunit, a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, announced that its AI-powered chest X-ray analysis software, Lunit INSIGHT CXR, had shown superior performance in detecting tuberculosis (TB) in a large-scale, independent study published in The Lancet Digital Health.
Despite being a curable disease, tuberculosis (TB) remains the world’s second leading cause of death from a single infectious agent, with an estimated 10.6 million new cases reported in 2022. A significant challenge in controlling TB is underdiagnosis, with 3.1 million cases remaining undetected that year. Although chest X-rays are more sensitive than symptom screening, their effectiveness is often hindered by variability in human interpretation and a shortage of radiologists in high-burden countries. This situation highlights the crucial need for advanced AI assistance.
The study, led by Dr. Zhi Zhen Qin and a research team from the Stop TB Partnership at UNOPS and Heidelberg University Hospital, assessed 12 commercially available AI products for TB detection using data from South Africa’s national TB prevalence survey. Lunit INSIGHT CXR achieved the highest area under the receiver operating characteristic curve (AUC) at 0.902, significantly outperforming the other products.
Key findings for Lunit INSIGHT CXR include:
- The highest AUC (0.902) among all tested products.
- 89.9% sensitivity at 67.7% specificity, aligning with the WHO target product profile.
- 89.5% sensitivity at 70.2% specificity, also meeting the WHO target product profile.
- Consistent high sensitivity (>90%) across a broad range of thresholds.
The study, which included 774 participants (258 bacteriologically confirmed TB cases), is the first to comprehensively evaluate multiple AI products in a high TB setting.
“This landmark study not only showcases our AI’s superior accuracy but also demonstrates its alignment with WHO standards,” said Brandon Suh, CEO of Lunit. “Lunit INSIGHT CXR’s ability to maintain high sensitivity across diverse populations and thresholds is particularly crucial in resource-limited settings, where every undetected case can have far-reaching consequences. By bridging the gap in TB diagnosis, we are contributing to a future where no case goes undetected, especially in regions where it matters most.”
The study’s findings have important implications for TB screening in high-burden areas. Lunit INSIGHT CXR’s strong performance, especially its ability to maintain high sensitivity across various thresholds, supports the development of customized screening strategies. This flexibility allows healthcare systems to enhance detection rates while efficiently managing resources for confirmatory testing, potentially making TB programs more accessible and cost-effective across different healthcare settings.
According to DelveInsight’s “Tuberculosis Diagnostics Market Report”, the global tuberculosis diagnostics market is estimated to grow at a CAGR of 5.11% during the forecast period from 2024 to 2030. The demand for tuberculosis diagnostics is primarily being boosted by the increasing prevalence of tuberculosis and multidrug-resistant tuberculosis (MDR-TB). Moreover, the availability of technologically advanced Point-of-Care (POC) diagnostic methods, increasing awareness about early diagnosis, increasing product launches and approvals, and innovation in product development among others, thereby contribute to the overall growth of the tuberculosis diagnostics market during the forecast period from 2024 to 2030.
