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Philips Teamed with SyntheticMR; BioPhotas’s Celluma Light Therapy; Boston Scientific’s AGENTTM Drug-Coated Balloon; Varian’s TrueBeam and Edge Radiotherapy Systems; Carthera’s Brain-Blood Barrier Trial; Prototype Device Effectively Treated Multiorgan Failure

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Philips Teamed with SyntheticMR; BioPhotas’s Celluma Light Therapy; Boston Scientific’s AGENTTM Drug-Coated Balloon; Varian’s TrueBeam and Edge Radiotherapy Systems; Carthera’s Brain-Blood Barrier Trial; Prototype Device Effectively Treated Multiorgan Failure

Mar 07, 2024

Philips Teamed with SyntheticMR to Deliver Breakthrough AI-based Quantitative Brain Imaging in MR to Advance Neurology Care For Patients

On March 01, 2024, Philips in collaboration with SyntheticMR announced the launch of Smart Quant Neuro 3D, a significant advancement in objective decision support for diagnosing and assessing therapy effectiveness in brain disorders such as Traumatic Brain Injury, Multiple Sclerosis (MS), and Dementia. This innovation aims to assist healthcare providers in delivering high-quality care to patients.

The groundbreaking Smart Quant Neuro 3D technology offers automated measurement of diverse brain tissues, improving decision support for brain diseases, tracking progression, and monitoring the efficacy of therapy.

Smart Quant Neuro 3D integrates Philips’ AI-driven SmartSpeed image-reconstruction technology, the Philips 3D SyntAc clinical application, and SyntheticMR’s SyMRI NEURO 3D quantitative tissue assessment software. This comprehensive solution equips healthcare providers with robust tools to enhance diagnostic certainty, ultimately improving patient outcomes. Through its exclusive agreement with SyntheticMR, Philips stands as the sole provider capable of offering SyMRI NEURO 3D capability on MR scanners.

“Life-changing brain injury and neurodegenerative disease are two of the most difficult diagnoses that clinicians have to make on a daily basis, because of the different symptoms exhibited by individual patients”, said Ruud Zwerink, Business Leader of MR at Philips. “With Smart Quant Neuro 3D, clinicians have access to an easy-to-use tool to provide valuable quantitative data to track the impact of treatments and make informed decisions about adjustments or alternative interventions as needed. This continuous monitoring enhances patient care by enabling proactive management of neurological conditions and optimizing therapeutic outcomes for patients.”

“Smart Quant allows for shorter exams and exploration of quantitative metrics, which show great potential to better stratify patients with similar imaging characteristics on conventional MR sequences. It’s a fast quantitative MR technique that’s integrated into our clinical workflow, allowing us to generate multiple synthetic weighted images from a single sequence,” said Dr. Julien Savatovsky, Neuroradiologist and Head of the Radiology Department at the Hospital Foundation Adolphe De Rothschild (Paris, France).

As per DelveInsight, the Traumatic Brain Injury Assessment Devices Market was valued at USD 2.8 billion in 2023, growing at a CAGR of 8.57% during the forecast period from 2024 to 2030 to reach USD 4.57 billion by 2030. The Traumatic Brain Injury assessment devices market is witnessing a positive growth owing to various factors such as the increasing road traffic crashes cases, increasing prevalence of Traumatic Brain Injury, rising geriatric population, and increasing regulatory approvals & launches of Traumatic Brain Injury assessment devices. Therefore, the market for Traumatic Brain Injury assessment devices is estimated to grow at a significant CAGR during the forecast period from 2024 to 2030.

Celluma Light Therapy Announced The Launch of Revolutionary Body Contouring Device 

On March 01, 2024, BioPhotas, Inc., a leading provider of therapeutic LED Light Therapy Devices, announced the launch of the Celluma CONTOUR, the sole FDA-cleared light therapy device designed for addressing body contouring, aging skin, and pain management.

The Celluma CONTOUR is equipped with a unique algorithm that administers light energy to the skin and underlying fat cells. This process reduces the accumulation of fat within adipose tissue, resulting in decreased circumferential measurements of the waist, hips, and thighs, along with enhancing the overall appearance of the skin. In a recent observational study, participants utilized the CONTOUR for 30 minutes, three times a week for four weeks, and achieved an average loss of two inches, all without altering their diet or exercise regimens. 

“The Celluma CONTOUR is the first LED Light Therapy device to be FDA-cleared on an Over-The-Counter basis for body contouring,” commented BioPhotas President and CEO, Curtis Cluff. “It is also the only LED light therapy device on the market designed with multiple treatment modes for reducing wrinkles, reducing muscle and joint pain, as well as body contouring in a single device.”

Commenting further on the product launch, Mr. Cluff said, “With the development of the CONTOUR, Celluma Light Therapy firmly establishes itself as the leader in whole-body wellness, with non-toxic, non-invasive, FDA-cleared devices treating everything from body contouring to hair loss, acne, aging skin, and general pain conditions. Like all Celluma devices, the CONTOUR is made with our patented, flexible, shape-taking design that can be easily shaped around any part of the body and made to fit all different body types.”

According to DelveInsight, the Light Therapy Market is estimated to grow at a CAGR of 5.47% during the forecast period from 2024 to 2030. The light therapy market is slated to witness prosperity owing to factors such as the growing prevalence of chronic skin problems such as acne and psoriasis among others coupled with rising awareness of skincare, an increasing number of individuals suffering from mood and sleep disorders, rising technological advancements in light therapy, and the growing focus on improving the safety and usability of light therapy are further expected to result in the appreciable revenue growth in the light therapy market in the upcoming years.

Boston Scientific Received FDA Approval for the AGENTTM Drug-Coated Balloon

On March 01, 2024, Boston Scientific Corporation announced that it received approval by the U.S. Food and Drug Administration (FDA) for its The AGENT™ Drug-Coated Balloon (DCB) for the treatment of coronary in-stent restenosis (ISR) in patients diagnosed with coronary artery disease. ISR refers to the blockage or narrowing of a stented vessel due to plaque or scar tissue.

The AGENT DCB is currently available in Europe, certain regions of Asia Pacific, and Latin America for treating patients with ISR and previously untreated small vessel coronary disease. Boston Scientific intends to introduce this technology in the United States in the forthcoming months.

“With more than 100,000 patients treated globally to date in both clinical and commercial settings, we are very pleased to introduce this proven therapy as the first drug-coated coronary balloon in the U.S,” said Lance Bates, president, Interventional Cardiology Therapies, Boston Scientific. “The AGENT DCB addresses a critical unmet need by providing a dedicated treatment option for the challenging condition of ISR and we look forward to offering U.S. physicians the opportunity to treat their patients with this novel device.”

“The AGENT IDE trial demonstrated that the AGENT DCB is an effective and safe treatment option for coronary in-stent restenosis, even in a high-risk population, which included many individuals with multi-layer stents or diabetes,” said principal investigator Dr. Robert W. Yeh, section chief of interventional cardiology at the Beth Israel Deaconess Medical Center. “Treating ISR has been challenging in the U.S. with limited therapies available, and this new technology will help physicians reduce the risk of restenosis without radiation or introducing additional metal layers, which do not provide an adequate result for some patients.”

According to DelveInsight, the Drug Eluting Balloons Market is estimated to grow at a CAGR of 8.31% during the forecast period from 2024 to 2030. The demand for drug-eluting balloons is primarily being boosted by the increasing prevalence of numerous heart diseases including peripheral and coronary artery diseases. Furthermore, the increasing preference for minimally invasive procedures, the advantages of balloon catheters over drug-eluting stents, the rising elderly population base, and others will propel the demand for drug-eluting balloons in the upcoming years. In addition, growing healthcare spending, especially in emerging countries, rising product launches and approvals, and surging research and developmental activities by the key players, among others are thereby contributing to the overall growth of the drug-eluting balloon market in the upcoming years.

Varian Received FDA 510 (k) Clearance for TrueBeam and Edge Radiotherapy Systems Featuring Hypersight Imaging Solution

On February 29, 2024  Varian, a subsidiary of Siemens Healthineers, declared that it obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for TrueBeam and Edge radiotherapy systems, which incorporated the HyperSight imaging solution.

HyperSight imaging enables clinicians to capture high-resolution images throughout a patient’s daily radiation therapy sessions. This advanced imaging capability aims to enhance precision in targeting tumor volumes while minimizing damage to healthy tissue in patients undergoing radiation therapy. With HyperSight integrated into linear accelerators across Varian’s product line, these devices can now generate images with the necessary Hounsfield Unit (HU) accuracy directly on the acquired cone-beam CT (CBCT) images. Consequently, this technology facilitates offline adaptive planning, allowing for adjustments to treatment plans based on anatomical changes to the tumor and surrounding organs over the treatment duration, eliminating the need for additional trips to a separate CT scanner.

The Cancer Institute at Northwell Lenox Hill in New York was one of the early adopters of HyperSight imaging on their Halcyon system. “HyperSight imaging has allowed us to improve patient comfort by decreasing the time patients spend on the treatment table while simultaneously targeting with greater confidence,” said Dr. Wesley Talcott, Assistant Professor and Radiation Oncologist, Department of Radiation Medicine at Lenox Hill Hospital. “We look forward to further streamlining care for our patients using HyperSight.” 

The Cancer Institute at Northwell Lenox Hill in New York was one of the early adopters of HyperSight imaging on their Halcyon system. “HyperSight imaging has allowed us to improve patient comfort by decreasing the time patients spend on the treatment table while simultaneously targeting with greater confidence,” said Dr. Wesley Talcott, Assistant Professor and Radiation Oncologist, Department of Radiation Medicine at Lenox Hill Hospital. “We look forward to further streamlining care for our patients using HyperSight.”

According to DelveInsight, the Radiotherapy or Radiation Oncology Devices Market is projected to grow at a 7.78% CAGR during the forecast period (2024-2030). The Radiotherapy/Radiation Oncology Devices market is witnessing positive growth owing to factors such as the rising cases of various cancers, further rapid technological developmental activities, strong R&D initiatives from key players, rising adoption of radiotherapy procedures in cancer treatment, growing demand for minimally invasive procedures, thereby contributing to the growth of the Radiotherapy/Radiation Oncology Devices market during the forecast period from 2024-2030.

Carthera Sees Positive Results in Brain-Blood Barrier Trial

On March 04, 2024, Carthera, a Paris based company, announced that its SonoCloud-9 system had the potential to facilitate the passage of specific drugs through the blood-brain barrier, based on encouraging findings from a Phase I/II clinical trial.

The trial investigating the SonoCloud-9, developed as an ultrasound-based therapy for various brain disorders like recurrent glioblastoma (rGBM), observed that the device exhibited a safe profile in opening the blood-brain barrier to facilitate the delivery of drug treatments.

The multi-center, multinational trial evaluated the safety and effectiveness of low-intensity pulsed ultrasound (LIPUS)-based technology utilizing the SonoCloud-9 system. The study involved 33 patients diagnosed with recurrent glioblastoma (rGBM) who received carboplatin. Conducted across six clinical sites, including four in France and two in the US, the trial aimed to assess the device’s performance.

Among the 12 patients who received carboplatin immediately prior to device usage, the one-year overall survival rate reached 58%, with a median overall survival of 14 months from surgery. In comparison, the typical survival rate for patients with recurrent glioblastoma (rGBM) historically ranges between 9 to 11 months.

Alexandre Carpentier, the founder of Carthera, said: “The publication of our clinical results in the highly respected Nature Communications journal demonstrates the significance of the SonoCloud technology as a viable new treatment option for patients with recurrent glioblastoma.”

According to DelveInsight, the Drug Delivery Devices Market is growing at a CAGR of 7.90% during the forecast period from 2024 to 2030. The demand for drug-delivery devices is primarily being boosted by the rising number of patients suffering from diabetes, the rising prevalence of cancer patients, the increasing frequency of both chronic and acute diseases, the rising growth of biologics, the increasing technological advancements associated with the drug delivery devices will help in contributing in the overall market growth of the drug delivery devices in the upcoming years.

Prototype Device Effectively Treated Multiorgan Failure

On March 04, 2024, results from a clinical trial described a groundbreaking medical device that, in a pilot study involving 10 patients, demonstrated remarkable efficacy in reversing multiorgan failure induced by acute-on-chronic liver failure.

All 10 patients had been formally placed on the liver transplant waiting list, but were removed from the list due to significant clinical deterioration caused by multiorgan failure. Following treatment with the new device, they all experienced improvements in their health significant enough to discontinue supportive measures and be reinstated on the transplant list.

Multiorgan failure (MOF) represents a critical condition, often described as being as close to death as one can be while still having the potential to recover. Ahmad identified various devices aimed at supporting individual organs during such crises: ventilators to aid lung function, hemodialysis machines to filter toxins typically cleared by the kidneys, and heart-lung bypass systems to deliver oxygenated blood to the body while allowing the lungs and heart to recover from acute injury or chronic illness.

These instruments, used alongside medications, frequently enable patients to survive and eventually leave the hospital on their own feet.

“For a long time, multiorgan failure was thought to be associated with sepsis only, but now we know that patients who have burn or trauma or severe damage to one vital organ sometimes can start this cascading failure of multiple organ system. Various clinical conditions are severe, either at presentation or they become severe within the course of hospitalization. Sepsis, severe pulmonary and cardiac injury, advanced liver and kidney failure, severe trauma and burn: All of these can lead to other organs becoming involved, often in a cascading fashion” said Ahmad. 

The LEARNS study will use individual measures from Koneksa’s neuroscience toolkit, to capture both clinician ratings and patient reported experiences. The study aims to address critical gaps in current knowledge in neurological disorders by harnessing the power of mobile EEG, wearable devices, and other advanced technologies to objectively measure sleep disturbances in real-world settings,” said Elena Izmailova, Ph.D., Chief Scientific Officer, Koneksa.

One of the very exciting features of the AMOR system is that it can remove a large volume of life-threatening excess body fluid in a way that cannot be matched by any other currently-used artificial organs, such as the artificial kidney,” said co-senior author Gao.

According to DelveInsight, the Neurology Devices Market is estimated to grow at a CAGR of 7.46% during the forecast period from 2024 to 2030. The neurology devices market is observing optimistic market growth due to factors such as the rise in the number of regulatory approvals for neurology devices across the globe. Further, the increasing cases of head injuries owing to accidents, workplace injuries, and others, and the rise in the geriatric population coupled with the increasing prevalence of neurological diseases are going to increase the demand for various neurological devices across the globe. Additionally, the growing focus on improving the safety, affordability, and usability of neurology devices for end users is further expected to result in appreciable revenue growth in the neurology devices market in the upcoming years. 

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