“We’re excited to expand our portfolio with the NPseal 20 and NPseal 25. FDA clearance for the additional large sizes allows NPseal to become the dressing of choice for the treatment of closed surgical incisions in orthopedic, cesarean, and cardiothoracic procedures,” stated Machiel van der Leest, CEO of Guard Medical. “We believe that NPseal uniquely fits in the ever-increasing outpatient trend requiring higher patient mobility and self-care.”
Negative pressure wound therapy (NPWT) demonstrated effectiveness in reducing surgical site complications (SSC) across numerous peer-reviewed studies. However, traditional disposable NPWT devices faced limited adoption due to their high cost and complexity. NPseal dressings were developed to address these challenges by offering a cost-effective and user-friendly alternative, expanding NPWT’s applicability, and driving market conversion from advanced wound dressings and standard dressings.
As per DelveInsight’s “Surgical Dressing Market Report,” the global surgical dressing market was estimated to grow at a CAGR of 5.72% during the forecast period from 2024 to 2030. The demand for surgical dressings is primarily being boosted by the increasing prevalence of chronic wounds, deep injuries, burns, ulcers, and other conditions requiring surgical treatment. Moreover, rising surgical procedures owing to the increasing prevalence of chronic diseases, accidents, traumas, and others will also accelerate the demand for surgical dressings. In addition, the increasing cases of organ transplant, the growing elderly population, the number of knee and hip replacement surgeries, and innovation in product development among others, thereby contributing to the overall growth of the surgical dressings market during the forecast period from 2024-2030.
PROCEPT BioRobotics Announced FDA Clearance of the HYDROSTM Robotic System, the Next-Generation AI-Powered Platform for Aquablation® Therapy
On August 21, 2024, PROCEPT BioRobotics Corporation, a surgical robotics company committed to enhancing patient care through innovative urological solutions, received FDA 510(k) clearance for its cutting-edge HYDROSTM Robotic System. Built on insights from over 50,000 procedures, the HYDROS™ platform integrates FirstAssist AI™ for advanced treatment planning, sophisticated image guidance, robotic resection, and an optimized workflow. This next-generation system is engineered to boost operational efficiency, elevate the experience for surgeons and staff, and provide a more precise and consistent treatment plan, ultimately driving improved clinical outcomes.
“We are pleased to bring the HYDROS Robotic System to the U.S. market,” said Reza Zadno, CEO of PROCEPT BioRobotics. “This milestone marks a pivotal moment for PROCEPT as Aquablation therapy continues its rapid adoption, with over 400 robotic systems now installed across the United States. After years of research and development, HYDROS introduces significant technological advancements designed for mass-market adoption, and we believe will power the next phase of our growth.”
“As a urologist, my goal is to treat my patients’ symptoms while preserving their quality of life. Aquablation therapy has been instrumental in helping me achieve this for patients struggling with BPH,” said Dr. Steven Kaplan, Icahn School of Medicine at Mount Sinai. “The HYDROS Robotic System advances this further by utilizing the power of AI to better read and interpret ultrasound for optimal surgical planning.”
The HYDROS robotic system marked the next advancement in Aquablation therapy, merging state-of-the-art technology with intuitive features to enhance clinical outcomes for both patients and healthcare providers.
The HYDROS Robotic System features AI-powered treatment planning with FirstAssist AI, leveraging a comprehensive library of real-world Aquablation therapy procedures. This technology utilized advanced image recognition software to precisely identify critical anatomical structures on ultrasound and recommend an optimal treatment plan tailored to each patient.
Its advanced image guidance system combined next-generation ultrasound imaging, digital cystoscopy, and dual high-definition touchscreens, offering superior visualization of anatomy and the ability to view ultrasound and cystoscopy images simultaneously.
As per DelveInsight’s “Surgical Robotic Systems 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 other diseases, the 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 to 2030.
GE HealthCare Announced MASTER Trial Results of End-Tidal Control Software, Demonstrated Safety and Efficacy for Inhaled Anesthetic Administration in Surgical Patients
On August 20, 2024, GE HealthCare, a medical technology company, announced the publication of MASTER trial results in the peer-reviewed journal Anesthesia and Analgesia. The study demonstrated the safety and efficacy of End-Tidal Control software for administering inhaled anesthetics in surgical patients. This advanced software autonomously maintains clinician-set targets for end-tidal anesthetic agents and oxygen concentrations and achieves superior performance in targets compared to traditional manual control methods.
The randomized, controlled MASTER trial (Multi-site Anesthesia Randomized Controlled Study of End-Tidal Control Compared to Conventional Anesthesia Results) was carried out at four hospitals in the United States. This study evaluated 210 adult patients undergoing general inhaled anesthesia for surgical procedures. This study compared the safety and efficacy of End-Tidal Control software against conventional manual methods in maintaining provider-set targets for end-tidal anesthetic agents and oxygen concentrations throughout the procedure.
“In the dynamic surgical environment, the repeated manual adjustment of fresh gas flows and anesthetic vaporizer settings required to deliver low-flow anesthesia can be challenging for anesthesia clinicians. Results from the MASTER trial showed that End-Tidal Control software was able to achieve and sustain desired oxygen and anesthetic agent concentrations more consistently and timely compared to conventional methods,” said Trial Investigator Melinda S. Seering, MD, Clinical Associate Professor of Anesthesia at the University of Iowa Healthcare. “As less anesthetic agent is needed to maintain the respective targets, End-tidal Control software can help enhance patient safety in the operating room, while reducing greenhouse gas emissions and costs.”
“Anesthesia professionals are focused on patient safety and have a history of utilizing technology to deliver improved clinical outcomes. End-tidal Control enables clinicians to automatically manage adequate oxygen and anesthetic delivery. Clinicians no longer have to continually adjust fresh gas flow and vaporizer settings, freeing up their time to focus on other tasks,” said John Beard, MD, anesthesiologist and Chief Medical Officer of Patient Care Solutions, GE HealthCare. “Results from the MASTER trial reinforce the value of End-tidal Control software in surgical settings to potentially help reduce unnecessary variability in care and meet the unique needs of individual patients.”
As healthcare systems grapple with workforce shortages, rising patient acuity, and escalating costs and administrative pressures, the demand for efficient care solutions becomes more urgent. GE Healthcare is developing software to integrate automation in anesthesia gas delivery that offers a promising solution by reducing the need for manual intervention and alleviating the cognitive load on clinicians. This not only helps to lower costs but also enhances the overall quality of patient care.
According to DelveInsight’s “Anesthesia Machines Market Report”, the global anesthesia machines market was estimated to grow at a CAGR of 8.2% during the forecast period from 2024 to 2030. The rise in demand for anesthesia machines is primarily attributed to the growing burden of various surgeries that require the administration of anesthesia to the patient during the operation among the worldwide population, increasing chronic diseases, and amassed old age population. In addition, an increase in investment and funds by the companies for the development of Anesthesia Machines are also the factors responsible for the global Anesthesia Machines market growth during the forecast period.
CollPlant and Stratasys Announced Pre-clinical Study for Regenerative Commercial-Sized Breast Implants, Bringing Advancement in Regenerative Medicines
On August 19, 2024, CollPlant Biotechnologies and Stratasys Ltd., announced the commencement of a pre-clinical study utilizing 200cc commercial-sized regenerative implants, produced with a Stratasys Origin® 3D printer. Stratasys is pioneering in polymer 3D printing solutions, while CollPlant is at the forefront of regenerative and aesthetic medicine, specializing in advanced technologies and products based on its proprietary rhCollagen for tissue regeneration and organ manufacturing. This collaboration aims to advance the field of regenerative medicine through innovative 3D printing technologies.
The collaboration between CollPlant and Stratasys centered on developing a bioprinting solution for CollPlant’s innovative breast implants, with a focus on scaling up the fabrication process. The pre-clinical study aimed to evaluate the implants’ effectiveness in promoting natural breast tissue growth and their ability to fully degrade over time.
Advanced breast implants, developed by CollPlant, were engineered to regenerate the body’s breast tissue without triggering an immune response. This breakthrough was expected to offer a transformative alternative for reconstructive and aesthetic procedures, potentially impacting a substantial segment of the $3 billion breast implant market.
“This pre-clinical study marks a significant step forward in our effort to provide patients with care using regenerative medicine instead of traditional implants,” said Stratasys CEO Dr. Yoav Zeif. “CollPlant’s work is truly inspiring, and our collaboration exemplifies how Stratasys partners with customers to push the timeline and the boundaries of innovation. Together, we are driven by a shared mission to challenge the status quo and find new ways to improve lives and advance healthcare.”
Yehiel Tal, CEO of CollPlant, commented, “We are extremely happy about the progress we’ve made with our breast implants program, and with Stratasys’ successful achievement to develop a printer that enables us to print a commercial-size implant with high resolution and optimal physical properties. The combined pioneering technologies of both companies are expected to streamline the development and production process so that we have the most efficient means to produce our regenerative breast implants. We believe that our rhCollagen-based regenerative implant has the potential to overcome the challenges of existing breast procedures that use silicone implants or autologous fat transfer, thereby significantly improving patient outcomes.”
The study evaluated 200cc 3D-printed breast implants made from CollPlant’s rhCollagen-based bioinks, produced using a Stratasys Origin® printer. The research focused on the evaluation of the implants’ ability to promote the growth of natural breast tissue and to fully degrade over time.
According to DelveInsight’s “Breast Implants Market Report”, the global breast implants market was valued at USD 1.93 billion in 2023, growing at a CAGR of 7.00% during the forecast period from 2024 to 2030, to reach USD 2.89 billion by 2030. The increase in demand for breast implants is predominantly attributed to the growing incidence of breast cancer among the population across the globe. In addition, the rise in demand for cosmetic surgeries among women to enhance their aesthetic appeal could also be a potential factor for increasing the market for breast implants. Moreover, an increase in the number of breast augmentation surgeries and technological advancement in the product portfolio is expected to bolster the breast implant market during the forecast period.
GE HealthCare Announced Collaboration to Investigate MRI Techniques, Embarking Women-specific Disease Imaging Expertise
On August 19, 2024, GE HealthCare, a leader in medical technology, announced a collaboration with the University Of California San Diego School Of Medicine to explore advanced MRI protocols and techniques tailored to female-specific pelvic diseases and conditions. The project aimed to develop comprehensive educational materials for clinicians, to enhance women’s pelvic health. The anticipated outcomes include improved diagnostic accuracy, faster disease detection, and expanded access to high-quality pelvic care for women, addressing a critical gap in medical research and practice.
The collaboration aimed to enhance women’s pelvic healthcare by increasing access to advanced imaging solutions for female patients. This partnership seeks to enable faster diagnosis and treatment, ultimately improving overall patient care.
“We aim to democratize advanced imaging for women and increase access to high quality care in the San Diego community and beyond,” said Dr. Rebecca Rakow-Penner, Director of the Women’s Imaging Lab at UC San Diego Health. “Women’s care requires a personalized approach and we hope to advance care solutions for women by improving the diagnosis and management of female pelvic conditions, both benign and malignant. The results of the collaboration will have the potential to help improve the patient experience and equip clinicians with a toolset to deliver a higher level of care that every woman deserves access to.”
“Diseases and conditions impacting female patients bellow the belly button are often misdiagnosed, misunderstood, and understudied in our industry,” stated Erin Angel, PhD, GE HealthCare Global Vice President, Research and Scientific Affairs. “We are optimistic that the results of the project could support more standard adoption of advanced imaging techniques and ultimately empower clinicians to make more informed decisions. We believe this project can help bridge an important gap in women’s healthcare and increase access of innovative solutions to women around the world.”
The project focused on the development of training and educational materials to accompany the new MRI protocols, making these resources available to GE HealthCare MRI users worldwide. This initiative aimed to create a lasting impact both regionally and globally by enhancing access to advanced imaging techniques. By equipping clinicians with these tools, the project seeks to drive more effective diagnosis and management of pelvic diseases and conditions in female patients.
According to DelveInsight’s “Magnetic Resonance Imaging Devices Market Report”, the global magnetic resonance imaging devices market size is estimated at USD 7.79 billion in 2023 and is expected to reach USD 11.28 billion by 2030, growing at a CAGR of 6.37% during the forecast period from 2024 to 2030. The magnetic resonance imaging devices market is witnessing positive growth owing to factors such as the rising cases of severe chronic diseases like various cancers, cardiac abnormalities, and others, further rapid technological developmental activities, growing geriatric population, rising adoption owing to non-invasiveness, thereby contributing to the growth of the Magnetic Resonance Imaging Devices market during the forecast period.
NOWDiagnostics First To Know® Syphilis Test Received De Novo Marketing Authorization for Over-the-Counter Use
On August 16, 2024, NOWDiagnostics, Inc., a medical technology company pioneering in development of over-the-counter and point-of-care diagnostic tests, announced that the U.S. Food and Drug Administration (FDA) granted marketing authorization for its First To Know® Syphilis Test, marking it as the first and only rapid syphilis test available for over-the-counter (OTC) use in the United States. This innovative test provides in-home results within 15 minutes using just a single drop of blood. Proven to be user-friendly in a clinical study involving 1,270 participants, the test was authorized through the FDA’s de novo pathway, distinguishing it as a novel device for syphilis testing and setting it apart from other products in the market.
“FDA granting De Novo authorization of our First To Know® Syphilis Test could not have come at a more important juncture in our country’s efforts to slow the rise of syphilis,” said Rob Weigle, CEO of NOWDx. “Testing is one of the most important tools we have in preventing the spread of sexually transmitted infections, and for the first time ever, consumers now have a fast and simple syphilis test that can be performed in the privacy of one’s home, with a result in minutes.”
“This FDA authorization is a significant milestone in addressing the syphilis epidemic,” said Dr. Gregory Bledsoe, MD, MPH, MBA, former Surgeon General for Arkansas. “After reviewing the robust data from the clinical studies, I am impressed with the test’s performance. There is a critical need to increase public awareness about the seriousness of untreated syphilis, especially in underserved and marginalized populations. An in-home test like this has the potential to greatly impact public health by improving access to timely detection and treatment.”
This test is a patented, buffer-less lateral flow device designed for the qualitative rapid detection of Treponema pallidum (syphilis) antibodies in human whole blood (capillary) from individuals at risk for syphilis infection. Clinical validation with 1,270 participants showed an impressive negative percent agreement (NPA) of 99.5%, indicating that it accurately identified 99.5% of negative cases, and a positive percent agreement (PPA) of 93.4%, demonstrating its accuracy in detecting 93.4% of positive cases compared to three FDA-cleared laboratory tests.
According to DelveInsight’s “Sexually Transmitted Diseases Diagnostics Market Report”, the global sexually transmitted diseases diagnostics market is estimated to grow at a CAGR of 7.81% during the forecast period from 2024 to 2030. The sexually transmitted diseases (STD) diagnostics market is observing remarkable market growth due to factors such as the growing incidence and prevalence of sexually transmitted diseases, rising innovations in the development of STD diagnostics devices, rise in implementation of national screening programs by various government organizations, surging demand of rapid point of care testing over the traditional testing, increasing product launches and approvals, presence of key players in the market, and other factors will create a requisite for the sexually transmitted diseases diagnostics devices in the market. Therefore, the market for sexually transmitted diseases (STD) diagnostics is estimated to grow at a substantial CAGR during the forecast period from 2024 to 2030.
