Samsung partnered with Lunit on AI for Enhanced Chest Screening

On January 25, 2024, Samsung entered into a supply collaboration with Lunit, in order to employ its AI-powered technology for conducting chest screenings.  The agreement was signed by Boston Imaging, which serves as the U.S. hub for Samsung’s digital radiography and ultrasound operations.

Lunit provides AI technology for cancer diagnosis and treatment. The collaboration between the two companies aims to enhance chest screenings by facilitating quicker and more precise assessments, leading to timely interventions and better patient results. Both the companies intend to integrate Lunit’s Insight CXR and Insight CXR Triage with Samsung’s computer-aided detection (CAD) AI. By leveraging Lunit’s chest X-ray analysis technology and FDA-cleared AI triage solution, the CAD AI assists radiologists in prioritizing patient examinations, particularly those with suspected abnormalities.

As of the first quarter of 2024, the companies have introduced the Lunit AI solution on Samsung digital radiology products. As the part of the agreement, Samsung aims to further validate the AI solution by extending its capabilities to detect the ten most prevalent abnormalities in chest X-rays. These abnormalities include nodules, pneumothorax, atelectasis, cardiomegaly, calcification, consolidation, pleural effusion, pneumoperitoneum, mediastinal widening, fibrosis, and support for tuberculosis screening.

Samsung Head of Digital Radiography, Eric Sumner, said “Chest X-rays are the most requested exam in radiography. By partnering with Lunit, our Samsung digital radiology products will now have computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence of suspected pleural effusion or pneumothorax. Patients with suspected findings will move to the top of the radiologist queue, allowing patients to be diagnosed more quickly. This will provide critical information to radiologists as they triage urgent cases.”

As per DelveInsight’s “Interventional Radiology Devices Market” report, the global interventional radiology devices market is expected to grow at a CAGR of 5.23% during the forecast period of 2023-2028. The increase in demand for interventional radiology devices is primarily attributed to the increasing patient pool due to an increasing prevalence of chronic disorders & cancer and due to the increasing number of geriatric patients globally. The interventional radiology devices works on minimally invasive techniques so it involves less severe surgical procedures, thereby leading to less hospitalization period. Thus, the rising demand of the reducing healthcare expenditure across the world is anticipated to bolster the market of the devices.

Furthermore, the rising awareness and the demand of minimally invasive techniques and the technological advancements in the devices such as illumination rendering technology, real-time images, and others across the world are anticipated to bolster the market, thereby contributing to the growth of the interventional radiology devices market during the forecast period from 2023-2028.

Boston Scientific Launched VersaVue single-use Flexible Cystoscope 

On January 25, 2024, Boston launched its VersaVue single-use flexible cystoscope. VersaVue broadens the company’s range of products designed to assist clinicians in diagnosing and treating urinary tract conditions. This FDA-approved device, facilitates visualization of the bladder and urethra lining, presenting images essential for conducting diverse diagnostic procedures. The scope has the potential to enhance scheduling and workflow efficiency by eliminating the time needed for reprocessing, repairing, and maintaining reusable scopes. Providing a sterile-as-packaged cystoscope for each patient can mitigate the risk of infection due to cross-contamination. Additionally, VersaVue could aid in reducing patient wait times caused by the shortage of reusable scopes.

The lightweight and compact nature of the system simplifies transportation across diverse clinical environments, including rural clinics. The portable 14-inch VersaVue tablet also presents high-definition images and video, without the need for extra equipment to view the live image. Medimaging Integrated Solution is responsible for the development and manufacturing of the VersaVue single-use flexible cystoscope. Through a distribution agreement, Boston Scientific exclusively markets and sells the product. Presently, it is only commercially available in the United States.

“By utilizing a new cystoscope for every procedure, the VersaVue single-use flexible cystoscope can help reduce post-procedure infections like urinary tract infections (UTIs) that can be associated with improper reprocessing of reusable scopes,” said Dr. Ron Morton, chief medical officer, Urology, Boston Scientific. “The addition of the VersaVue Single-Use Flexible Cystoscope helps round out the comprehensive suite of urologic solutions we’re able to offer to our customers and their patients.”

According to DelveInsight’s “Urinary Tract Infection Devices Market” report, the global urinary tract infection devices market is estimated to grow at a CAGR of 4.50% during the forecast period from 2023 to 2028. The urinary tract infection market is slated to witness prosperity owing to factors such as the increasing prevalence of urinary tract infections and kidney stones, growing burden of the geriatric population, and the rising launch of combination drugs are further expected to result in the appreciable revenue growth in the Urinary Tract Infection Devices market during the forecast period (2023-2028).

Element Science Won CE Mark for Patch-wearable Cardioverter Defibrillator

On January 26, 2024, AnX Robotica announced that it had received CE mark approval or its novel patch-wearable cardioverter defibrillator (P-WCD). The Jewel P-WCD has also received the U.K. Conformity Assessed (UKCA) marking, granting approval for its marketing in the U.K. Element Science, headquartered in San Francisco, designed Jewel with a focus on enhancing the patient experience, crafting a low-profile and lightweight design. This water-resistant device enables patients to comfortably wear Jewel during everyday activities such as showering and exercising. 

The device provides continuous monitoring of a patient’s heart and administers targeted therapy for specific life-threatening rhythms. The Jewel Mobile App facilitates prompt patient care by transmitting therapy data to the patient’s medical team almost instantly.

“Gaining the CE mark under the rigorous European Union Medical Device Regulation (EU MDR) as well as the UKCA mark are testaments to the strength of the development, testing, and clinical results of the Jewel P-WCD,” said Dr. Uday Kumar, founder, president and CEO.

Former Boston Scientific CEO Hank Kucheman said “Element Science is on the leading edge of leveraging advancements in machine learning, wearable technologies, and miniaturization to revolutionize the way patients receive care.”

According to DelveInsight’s “Defibrillator Market” report, the global Defibrillators Market was valued at USD 10.19 billion in 2022, growing at a CAGR of 3.11% during the forecast period from 2023 to 2028, to reach USD 12.24 billion by 2028. The demand for defibrillators is primarily associated with the growing incidence of cardiac disorders, integration of advanced technology, increasing investments by government and private manufacturers, and rising awareness programs regarding cardiovascular disorders and the usage of defibrillators, among others.

BIOCORP Received 510(k) FDA Clearance for SoloSmart®, Sanofi’s Smart Cap for Disposable Insulin Pens

On January 25, 2024, Novo Nordisk, a French company specializing in the design, development, and manufacturing of novel medical devices, announced that it had received 510(K) clearance from the U.S. Food & Drug Administration (FDA) to market SoloSmart®.

Exclusively designed, developed, and manufactured for Sanofi by BIOCORP, SoloSmart is an intelligent sensor directly integrated with Sanofi’s SoloStar insulin pen platform, transforming the pens into connected devices. SoloSmart seamlessly gathers and logs crucial treatment details such as selected insulin units, injection date, and time, transmitting them to a dedicated digital application. This innovation provides healthcare professionals with a convenient means to monitor patients, particularly in scenarios involving multi-therapy treatments, such as combining basal and rapid insulins.

Eric Dessertenne, CEO of BIOCORP, said: “This approval is a major achievement for SoloSmart and our commercial partner, Sanofi. We have brought together our unique expertise in medical devices and innovative therapies to allow the commercial launch of SoloSmart in the United States, answering to patients’ needs to simplify their treatment journey. It also illustrates BIOCORP’s ability to meet the highest regulatory requirements and reinforces the Mallya platform as the best in class in the smart pen market”.

According to DelveInsight’s “Insulin Pens Market” report, the global insulin pens market will grow at a CAGR of 3.45% during the forecast period from 2023 to 2028. The increase in demand for insulin pens is primarily attributed to the increase prevalence of diabetes mellitus due to genetic factor, age, obesity, and unhealthy lifestyles, increasing number of geriatric patients, enhanced awareness of self-management through insulin pens and advancements in telemedicine across the world are anticipated to bolster the market, thereby contributing to the growth of the insulin pens market during the forecast period from 2023-2028.

CroiValve Won FDA IDE for Tricuspid Heart Valve 

On January 25, 2024, CroiValve, initiated feasibility study for its Duo tricuspid coaptation valve system. The study commences after obtaining approval from the FDA for investigational device exemption (IDE). Tandem II is a prospective, multi-center, non-randomized, single-arm study examining the safety and performance of Duo in patients with severe or more symptomatic tricuspid regurgitation (TR).

CroíValve, headquartered in Dublin, Ireland, developed a simple implant procedure. It utilizes standard imaging techniques and adapts to the significant anatomical variations observed in the target patient group. The company’s Tandem I trial, the first of its kind in Europe, revealed significant symptomatic improvement in patients across all primary metrics. Moreover, these cases underscored the procedure’s ease of learning and execution.

“We are delighted to initiate TANDEM II, with strong interest in participation in the study from leading U.S. centers. This marks a significant step forward in our efforts to continue generating clinical evidence demonstrating the safety and effectiveness of Duo,” said Lucy O’Keeffe, CEO of CroíValve. “We are confident it has the potential to revolutionize the standard of care by redefining how TR is treated, and ultimately enhancing the lives of patients in need.”

According to DelveInsight’s “Tissue Heart Valve Market” report, the global Tissue Heart Valves market is, growing at a CAGR of 10.14% during the forecast period from 2023 to 2028. The demand for tissue heart valves is primarily witnessing growth on account of the high prevalence of heart valve diseases such as aortic valve degeneration and aortic stenosis, the increase in demand for minimally invasive procedures, technological advancements of the tissue heart valves and longer life expectancy of the geriatric population.

FastWave Medical Started First-in-human Study of its IVL Tech

On January 17, 2024, FastWave announced the completion of enrollment for its first-in-human study for peripheral intravascular lithotripsy (IVL) system in order to treat calcified cardiovascular disease.  

The procedures were successfully carried out by Dr. Miguel Montero-Baker from Houston Methodist Hospital and the Hope Vascular & Podiatry Clinic, along with Dr. Venkatesh Ramaiah from HonorHealth Vascular Group and the Pulse Cardiovascular Institute, under the supervision of the hosting investigator, Dr. Antonio Muñoa.

The IVL platform developed by FastWave, which is headquartered in Minneapolis, is designed to address calcific artery disease by utilizing a balloon catheter to deliver shock waves that fracture calcium deposits. FastWave asserts that its peripheral IVL technology boasts a user-friendly design featuring a deliverable, low-profile, and rupture-resistant balloon. The system applies durable and predictable circumferential ultrasonic pressure to effectively fracture calcium.

“I am excited to be part of the initial cases to evaluate FastWave’s peripheral IVL platform. Their team has rapidly developed an easy-to-use system to address existing technological gaps, marking a significant milestone in achieving the company’s near-term goals,” said Montero-Baker. 

“Calcium poses significant therapeutic challenges in treating peripheral artery disease, and many of the existing modalities are not optimal for addressing medial and deep plaque,” Ramaiah said. “FastWave’s peripheral IVL technology is a promising advancement in calcium modification, and I am excited by the procedural success in these initial cases.”    

According to DelveInsight’s “Lithotripsy Market” report, the Global Lithotripsy Devices Market was valued at USD 1.44 billion in 2022, growing at a CAGR of 4.35% during the forecast period from 2023 to 2028, to reach USD 1.87 billion by 2028. The Lithotripsy Devices market is expected to witness growth owing to the rising prevalence of urolithiasis, technological advancements in product development, increased risk of end-stage renal failure, rising awareness for the procedure, and the growing geriatric population.