“We are thrilled to broadly introduce our xT CDx test, which combines the trusted performance our clinicians rely on, now with FDA approval,” said Ezra Cohen, MD, Chief Medical Officer of Oncology at Tempus. “Tempus has an unwavering commitment to providing high quality and robust assays so clinicians have the most comprehensive and actionable insights in a timely manner. This is consistent with the goal of improving the outcomes for all of their patients, and we look forward to providing xT CDx nationally to make that possible.”
xT CDx is a qualitative, Next Generation Sequencing (NGS)-based in vitro diagnostic device designed to detect substitutions (single nucleotide variants [SNVs] and multi-nucleotide variants [MNVs]), insertion and deletion alterations (INDELs) in 648 genes, and microsatellite instability (MSI) status. It uses DNA extracted from Formalin-Fixed Paraffin-Embedded (FFPE) tumor tissue specimens and matched normal blood or saliva specimens from patients previously diagnosed with solid malignant neoplasms.
The test serves as a companion diagnostic (CDx) to identify patients who may benefit from targeted therapies listed in the Companion Diagnostic Indications table, as specified in the approved therapeutic product labeling. Additionally, xT CDx provides tumour mutation profiling for use by qualified healthcare professionals, following professional oncology guidelines, for patients with diagnosed solid malignant neoplasms.
As per DelveInsight’s “Companion Diagnostics Market Report,” the global companion diagnostics market was valued at USD 5.91 billion in 2023, growing at a CAGR of 12.32% during the forecast period from 2024 to 2030, to reach USD 11.89 billion by 2030. The increase in the market for companion diagnostics is predominantly owing to an exponential rise in cancer cases across the globe. Additionally, the rise in awareness regarding precision medicine among the patient population as well as the growing focus of the manufacturers concerning the development of precision medicine has bolstered the demand for companion diagnostics. Furthermore, an increase in research and developmental activities for developing companion diagnostics for non-cancer disorders and growing approvals and launches of various companion diagnostic products in the market, among others are some of the key factors anticipated to augment the global market for companion diagnostics during the forecast period (2024-2030).
B. Braun Launched Clik-FIX® Epidural/PNB Catheter Securement Device
On January 21, 2025, B. Braun Medical Inc. (B. Braun), a leading provider of smart infusion therapy and pain management solutions, announced the launch of its newest product, the Clik-FIX® Epidural/Peripheral Nerve Block (PNB) Catheter Securement Device. This innovative device is the latest addition to the Clik-FIX Family of Catheter Securement Devices.
Displacement and dislodgement of epidural and PNB catheters can compromise post-operative pain management. There are no universally recognized standards or guidelines for securing epidural or PNB catheters, leading to inconsistencies in patient care. Implementing a securement device for all epidural and PNB catheters can help promote consistency and improve standardization in patient care and post-operative pain management.
The Clik-FIX Epidural/PNB Catheter Securement Device is designed to be soft, low-profile, and secure, minimizing the risk of catheter displacement and dislodgement during regional anesthesia procedures. Engineered for easy application and dependable securement, these devices aim to simplify the process for both patients and healthcare professionals.
“We take pride in being the U.S. market leader in regional anesthesia. The Clik-FIX Epidural/PNB Catheter Securement Device is a perfect fit for our broad regional anesthesia portfolio, demonstrating our commitment to patient safety and satisfaction,” said Peter McGregor, Director of Marketing, Pain Control.
According to DelveInsight’s “Pain Management Devices Market Report”, the pain management devices market was valued at USD 4.86 billion in 2023, growing at a CAGR of 7.90% during the forecast period from 2024 to 2030, to reach USD 7.67 billion by 2030. The rising prevalence of chronic pain conditions, coupled with an increase in product launches and growing awareness about pain management, is set to significantly boost the market for pain management devices. As more people suffer from chronic pain, the demand for effective and innovative solutions grows, prompting major companies to introduce advanced and minimally invasive devices. This influx of new products not only provides patients with more treatment options but also drives competition and innovation within the market. Additionally, heightened awareness of pain management techniques and devices among the global population, spurred by educational campaigns and patient advocacy, leads to greater acceptance and adoption of these devices. Together, these factors create a favorable environment for the expansion and growth of the pain management devices market, ensuring better patient outcomes and improved quality of life for those suffering from chronic pain during the forecast period from 2024 to 2030.
Illuccix® Received European Approval
On January 17, 2025, Telix announced that it received a positive decision on its Marketing Authorization Application (MAA) for Illuccix® (a kit for the preparation of gallium-68 gozetotide injection), its prostate cancer PET imaging agent. The application was submitted in Europe through a decentralized procedure (DCP).
This major milestone follows the issuance of the Final Assessment Report by the German Competent Authority BfArM, acting as the Reference Member State (RMS). Under the decentralized procedure (DCP), the RMS and all 18 European Economic Area (EEA) Concerned Member States (CMS) had agreed that Illuccix should be granted marketing authorization. The regulatory process will now move into an administrative national phase to implement these authorizations, paving the way for the commercial launch in each country.
Kevin Richardson, Chief Executive Officer, Telix Precision Medicine commented, “We are delighted by this positive outcome, setting the stage for a European commercial launch of Illuccix. This clinically important prostate cancer imaging modality is currently recommended in international clinical practice guidelines including European Association of Urology (EAU) and European Society for Medical Oncology (ESMO).”
PSMA-PET imaging marks a significant breakthrough in the management of prostate cancer, largely supplanting traditional imaging techniques (such as bone scans and CT scans) as the standard of care following initial diagnosis and biochemical recurrence (BCR). European guidelines emphasize the superior accuracy of PSMA-PET for staging primary disease and assessing BCR/biochemical persistence (BCP).
As per DelveInsight’s “PET-MRI 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.
CapsoVision’s CapsoCam Plus® Capsule Endoscopy System Earned FDA Clearance to Continue Remote Ingestion, Further Expanding Access and Comfort for Patients
On January 21, 2025, CapsoVision, Inc., a leader in innovative endoscopic capsule technology, announced that its CapsoCam Plus® capsule endoscopy system received U.S. Food & Drug Administration (FDA) clearance for remote ingestion. This milestone enables patients to ingest the CapsoCam Plus capsule from the comfort of their homes, with virtual medical supervision, marking a significant advancement in improving patient accessibility and comfort for small bowel diagnostic procedures.
CapsoCam Plus stands out because it typically eliminates the need for hospital or clinic visits, unlike other capsule endoscopy systems that require two visits—one for ingestion and another to return the equipment. With the recent FDA clearance for remote ingestion, eligible patients can now bypass clinic visits entirely. They can ingest the capsule at home and continue their day without the need for external data recording devices. The wire-free onboard storage design simplifies capsule administration, making the process faster and more efficient, while streamlining the workflow for physicians and their practices. This added convenience makes the CapsoCam Plus system an ideal tool for expanding care via telehealth and reducing the burden on both patients and healthcare providers.
The remote ingestion of the CapsoCam Plus capsule has been successfully implemented in medical centers serving patients in remote areas of Canada, with positive outcomes reported in the literature (Journal of the Canadian Association of Gastroenterology, 2021). In 2020, CapsoVision received enforcement discretion from the FDA during the COVID-19 pandemic for eligible patients in the U.S., allowing at-home administration. The labeling addendum enabled a fully remote capsule endoscopy procedure for these patients, eliminating the need for in-person interactions between clinic staff and patients. The recent FDA clearance now extends this flexibility, allowing patients to continue ingesting the CapsoCam Plus capsule remotely beyond the initial provisions granted during the pandemic.
“We are honored to announce the FDA’s clearance to continue remote ingestion of CapsoCam Plus,” said Johnny Wang, President and CEO of CapsoVision. “By offering a remote option, healthcare providers can significantly enhance patient convenience and broaden the scope of accessible care.”
This significant milestone for both patients and physicians is supported by a comprehensive protocol for the remote ingestion of the small camera device, ensuring the same high standard of care as in a clinical setting. Study participants have reported that the capsule is easy to swallow and is preferred by patients over other capsule endoscopy systems. The process begins with a Risk Assessment Patient Questionnaire to evaluate any potential risks associated with capsule ingestion. During a scheduled virtual visit, a healthcare provider confirms the patient’s readiness, inspects the capsule packaging, and provides step-by-step guidance throughout the ingestion process, offering real-time supervision to ensure safety. After ingestion, the provider continues to monitor the patient remotely, with an adult present to assist if necessary. This thorough oversight allows patients to safely undergo capsule endoscopy from the comfort of their homes.
CapsoCam Plus is designed to provide high-resolution, panoramic visualization of the small bowel mucosa, offering physicians a comprehensive tool for detecting abnormalities. It is the only capsule endoscopy system equipped with four cameras, capturing a 360° panoramic view of the small bowel to improve visibility and diagnostic accuracy. In contrast to traditional capsule endoscopes with a single forward-facing camera, which may overlook important details, CapsoCam’s advanced imaging technology reduces the risk of missed lesions by capturing high-resolution images of the entire small bowel. This advantage enables physicians to examine critical areas of the mucosa more thoroughly, enhancing visibility and diagnostic confidence.
“CapsoVision is completely changing the game by offering 360° panoramic imaging, providing a comprehensive view of the small bowel mucosa, combined with the ease of use of remote ingestion and streamlined workflows for physicians. This advancement demonstrates our continued commitment to transforming diagnostic accuracy, patient experience, and practice efficiency,” said Doug Atkinson, Senior Vice President at CapsoVision.
As per DelveInsight’s “Capsule Endoscopy Market Report,” the global capsule endoscopy market is estimated to grow at a CAGR of 9.61% during the forecast period from 2024 to 2030. The demand for capsule endoscopy is primarily being boosted by the growing prevalence of gastrointestinal disorders such as Chron’s disease, inflammatory bowel disease, colorectal cancer, esophageal cancer, and others. Furthermore, the capsule endoscopy market is anticipated to grow on account of a large number of ongoing improvements in product development, and technological advancement contributing to the overall growth of the capsule endoscopy market. These are some of the major drivers that are responsible for contributing to the positive growth of the capsule endoscopy market during the forecast period from 2024-2030.
BellaSeno Successfully Completed Two Clinical Trials with Novel Resorbable Breast Implants
On January 14, 2025, BellaSeno GmbH, an ISO 13485-certified medtech company specializing in the development of resorbable scaffolds using additive manufacturing technologies, announced that all 19 breast scaffold patients enrolled in an Australian breast augmentation revision trial in 2022 had completed a one-year follow-up without any major scaffold-related complications or removals.
Additionally, in a parallel Australian clinical trial, 7 pectus excavatum patients have also completed their one-year follow-up. These trials are the first to use a novel approach combining polycaprolactone (PCL) scaffolds, which ultimately results in a fully resorbed implant and natural tissue. The data suggest that silicone implants in breast augmentation can be replaced with alternative materials that offer improved safety and a better quality of life.
The trials are sponsored, single-arm, open-label, mono-centric, interventional, and prospective clinical studies conducted in patients requiring breast augmentation revisions or surgical correction of pectus excavatum. The primary endpoint is the post-operative safety of the device, while secondary endpoints include post-operative patient safety and the post-operative performance of the device, including quality of life (QOL) and volume replacement.
The one-year assessment confirms the excellent safety profile of BellaSeno’s resorbable soft tissue implants. No major complications, such as capsular contracture, calcifications, oil cysts, infections, tissue necrosis, or wound healing issues, were observed. There were no instances of scaffold removals or replacements, and no scaffold-related complications were noted in any patients six months after surgery.
“This is a very encouraging one-year clinical outcome,” said Mohit Chhaya, CEO of BellaSeno. “The data confirm that our resorbable scaffolds do not only meet the desired safety criteria but also show an improvement of patients´ quality of life. We now have a very strong clinical data set to initiate a pivotal study of our resorbable breast scaffolds in the U.S. and Europe. We will also expand the use of our scaffolds to primary breast augmentation and lumpectomy and also provide a final two-year follow-up next year.”
As per DelveInsight’s “Breast Implants Market Report,” the breast implants market was valued at USD 1.80 billion in 2023, growing at a CAGR of 7.00% during the forecast period from 2024 to 2030 to reach USD 2.70 billion by 2030. The breast implants market is experiencing significant growth due to the increasing instances of breast cancer, rising product developmental activities, rise in breast reconstructive and cosmetic surgeries, and the availability of a wide variety of breast implants that are acting as major factors contributing to the overall growth of the breast implants market during the forecast period from 2024 to 2030.
Conformal Medical Announced GLACE Study to be highlighted at AF Symposium
On January 16, 2025, Conformal Medical, Inc. announced that the early results of its GLACE study will be presented at the Annual AF Symposium in Boston, MA, on Friday, January 17th. The presentation will showcase the initial clinical use of the new CLAAS® AcuFORM™ device as part of the prospective, multicenter, single-arm European study. Importantly, the study assesses device performance using Intracardiac Echocardiography (ICE) imaging, enabling patients to undergo left atrial appendage occlusion (LAAO) treatment without the need for general anesthesia.
“We are excited to share the initial case experience with the AcuFORM device. The unique foam construction allowed for immediate assessment of the seal under ICE guidance, a huge advancement with regards to both patient comfort and operational efficiency,” stated Shephal Doshi, M.D., from Providence Saint John’s Health Center and the Pacific Heart Institute in Santa Monica, California, and Principal Investigator of the CONFORM Pivotal Trial. “Furthermore, almost all the patients were successfully treated with the regular-size device, which is consistent with our experience in the CONFORM Trial and further validates the system’s simplified sizing and ease of use. I am pleased with the performance in these cases and look forward to using the CLAAS AcuFORM device in the CONFORM Trial after these promising results.”
Additionally, Conformal confirmed that more than 30 patients worldwide have been treated with the new CLAAS AcuFORM LAAO device as part of the CONFORM IDE Trial and the European GLACE Study. The device features a user-friendly delivery system and preserves the benefits in both sizing and sealing observed with the first-generation device. The CLAAS® System provides an alternative option for patients and physicians to seal the left atrial appendage (LAA) and reduce stroke risk without the need for long-term anticoagulant therapy.
“Patient enrollment in the GLACE Trial with the CLAAS AcuFORM System is a significant milestone as we work to provide physicians and patients with a new disruptive alternative to current offerings,” said James Reinstein, President and CEO of Conformal Medical. “Over 420 patients have been successfully randomized in the CONFORM Pivotal Trial to date. We look forward to offering patients the benefit of the CLAAS AcuFORM in both the CONFORM and GLACE Trials going forward.”
According to DelveInsight’s “Left Atrial Appendage Closure Device Market Report”, the global left atrial appendage closure device market was valued At USD 1,206.94 Million in 2023, growing at a CAGR Of 11.45% during the forecast period from 2024 to 2030 to reach USD 2,564.70 million by 2030. The demand for left atrial appendage closure devices is primarily being bolstered by the rising prevalence of cardiovascular disorders such as atrial fibrillation, ischemic strokes, and heart attacks. Additionally, increasing technological advancement in the domain of left atrial appendage closure, is another key factor that is contributing to the growth of the left atrial appendage closure market during the forecast period from 2024 to 2030.
