“The radiopharmaceutical sector is at an inflection point thanks in large part to innovation in the pharmaceuticals space, with PET serving as a gateway to patient eligibility for many of the new cancer and neurodegenerative-disorder therapies,” said Jim Williams, head of Molecular Imaging at Siemens Healthineers. “But even the greatest therapy is of no use unless you can get it to patients in time, so we’re excited to be adding the molecular imaging capabilities of Advanced Accelerator Applications, its first-class operations, extensive experience in nuclear medicine, and proven track record.”
The transaction encompasses Advanced Accelerator Applications Molecular Imaging’s manufacturing and distribution network, its workforce of around 420 employees, its established product portfolio, and its partnerships with radioligand imaging developers.
“We’re delighted to welcome our new colleagues to Siemens Healthineers and start our collaboration at this time of unprecedented growth in our industry,” said Barry Scott, CEO of PETNET Solutions.
As per DelveInsight’s “Diagnostic Imaging Equipment Market Report”, the global diagnostic imaging equipment market was valued at USD 24.15 billion in 2023, growing at a CAGR of 5.10% during the forecast period from 2024 to 2030, to reach USD 33.56 billion by 2030. The demand for diagnostic imaging equipment is primarily attributed to the rising technological advancement, growing burden of chronic diseases, increasing patient awareness regarding early-stage diagnosis, growing demand for effective & efficient imaging technologies for diagnosis, and increasing geriatric population.
BD and Babson Diagnostics Launched Innovative Fingertip Blood Testing to Health Care Organizations
On December 17, 2024, BD, a global leader in medical technology, and Babson Diagnostics, a healthcare technology company focused on science-driven innovation, announced the expansion of fingertip blood collection and testing technologies. These solutions will be made available to the U.S. health systems and large provider networks, including settings such as urgent care centers, physician offices, and other ambulatory care facilities.
This groundbreaking blood testing method combines BD’s MiniDraw™ Capillary Blood Collection System with Babson’s BetterWay technologies, enabling test results from just six drops of capillary blood taken from a patient’s finger. Offering a less-invasive alternative to traditional venipuncture, the system allows any trained healthcare worker — even those without prior phlebotomy experience — to collect and prepare samples.
Since 70% of clinical decisions rely on diagnostic results, blood tests are a vital part of patient care, aiding in diagnosis, monitoring, and treatment. This innovative capillary solution improves access to blood testing in underserved areas without phlebotomy services and addresses common barriers such as needle anxiety and logistical difficulties.
“In areas of the U.S. where there are gaps in services or shortages of trained phlebotomy professionals, patients may experience delays in blood draws or not receive the care they need,” said Bridget Bagnato, worldwide president of Specimen Management at BD. “By simplifying one of the most common procedures, together we’re making blood testing less invasive and more convenient to help health care organizations increase efficiency and access while helping to improving patient satisfaction and outcomes.“
The commercial partnership builds on the longstanding collaboration between BD and Babson to advance capillary blood testing, which began in 2016 and has since developed into a strategic alliance.
“BetterWay and BD MiniDraw™ are defining what’s next in health care,” said David Stein, Babson’s CEO. “BD has been innovating blood collection technology for 75 years and we believe our partnership will deliver a potentially transformative technology to support innovative and patient-focused health care organizations in better reaching and serving patients.”
BetterWay blood testing has been available in retail settings since May 2024, increasing access to blood collection at new locations such as local pharmacies. This ongoing expansion will soon make it accessible to patients at ambulatory care sites across the United States.
According to DelveInsight’s “Blood Collection Devices Market Report”, the global blood collection devices market was valued at USD 6.23 billion in 2023, growing at a CAGR of 6.85% during the forecast period from 2024 to 2030 to reach USD 9.25 billion by 2030. The blood collection devices market is slated to witness prosperity owing to factors such as the increase in diagnostic tests owing to the growing prevalence of infectious diseases such as COVID-19, malaria, and others, increasing awareness over health, rise in blood transfusion procedures, and the growing focus on improving the safety and usability of blood collection devices for end users are further expected to result in the appreciable revenue growth in the blood collection devices market during the forecast period (2024 to 2030).
Medtronic Announced Successful First Ingestion of New Pillcam™ Genius Sb Kit
On December 12, 2024, Medtronic plc, a global leader in healthcare technology, announced that the University of Miami Health System (UHealth) successfully performed the first-ever patient procedure using its next-generation PillCam™ Genius SB capsule endoscopy kit. The PillCam™ Genius SB Kit provides enhanced flexibility for both patients and physicians, with simplified equipment management that allows patients to complete the procedure in a hospital, clinic, or even from the comfort of their home during a telehealth appointment.
The PillCam™ Genius SB Kit is specifically designed to visualize the small bowel mucosa in adult patients, helping to detect and monitor conditions such as Crohn’s disease, obscure gastrointestinal bleeding, and iron deficiency anemia, especially when these issues are not detected through conventional upper or lower endoscopy.
“Capsule endoscopy technology has advanced so that equipment management is simplified and makes capsule endoscopy more accessible and patient-centric,” said Jodie A. Barkin, M.D., FACG, FASGE, gastroenterologist at UHealth, Director of Pancreatic and Small Bowel Diseases, and Associate Professor of Clinical Medicine at the University of Miami Miller School of Medicine. “The ability to conduct procedures remotely, combined with the seamless integration of advanced imaging, streamlines workflows for healthcare providers with additional capabilities and flexibility for health systems, and enhances the patient experience.”
The PillCam™ Genius SB Kit includes a link device that replaces traditional data recorders. This wearable, single-use device efficiently stores images transmitted by the capsule and notifies patients with haptic vibrations, audible signals, and LED lights when their procedure is complete. Additionally, the system is designed for patient comfort, featuring an easy-to-apply and remove adhesive for the link device.
“Advancing diagnostic precision while prioritizing patient convenience is at the core of what we do,” said Raj Thomas, president of the Endoscopy business within the Medical Surgical Portfolio at Medtronic. “This first ingestion highlights the potential of the PillCam™ Genius SB Kit to transform small bowel diagnostics, providing greater accessibility and ease for both patients and clinicians alike.”
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 from2024 to 2030.
U.S. FDA Expanded Indication for Impella Heart Pumps to Treat Pediatric Patients
On December 12, 2024, Johnson & Johnson MedTech, a global leader in heart recovery, announced that the U.S. Food and Drug Administration (FDA) expanded the approved indications for the Impella 5.5 with SmartAssist and Impella CP with SmartAssist heart pumps. These devices have now received premarket approval (PMA) for use in select pediatric patients experiencing symptomatic acute decompensated heart failure (ADHF) and cardiogenic shock. PMA represents the FDA’s highest standard of approval, confirming the safety and effectiveness of medical devices.
The Impella 5.5 and Impella CP, part of the world’s smallest heart pump platform, are designed to support heart recovery. Johnson & Johnson MedTech (Abiomed, Inc.) has collaborated with the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) to gather real-world data supporting the on-label use of these left-sided heart pumps in pediatric patients with symptomatic acute decompensated heart failure (ADHF) and cardiogenic shock. ACTION is a global healthcare network of patients, families, clinicians, researchers, and industry representatives working together under ACTION leadership to enhance patient outcomes.
“This marks a monumental achievement for children with heart failure as, historically, this area of pediatric care has been underfunded and understudied,” said Angela Lorts, MD, MBA, and David Rosenthal, MD, Co-Founders of ACTION. “We are proud to have worked with Johnson & Johnson MedTech on this crucial approval and look forward to further collaborations that will enhance care for these vulnerable patients.”
The Impella CP and Impella 5.5 heart pumps reduce the workload on the heart’s left ventricle, enabling the heart to rest while maintaining the circulation of oxygenated blood throughout the body. The PMA amendment extends the approved use of these left-sided Impella devices to specific pediatric patients weighing at least 52 kg for the Impella CP and 30 kg for the Impella 5.5.
“The opportunity to treat the hearts of pediatric patients with our life-supporting technology is incredible and fills us with gratitude,” said Sonya Bhavsar, PhD, Senior Director, R&D, ECP & Pediatrics Platform, Heart Recovery, Johnson & Johnson MedTech. “This milestone motivates us to continue innovating solutions to increase the number of life years that these patients have and can spend with their families and loved ones.”
As per DelveInsight’s “Heart Pump Devices Market Report”, the heart pump devices market was valued at USD 4.44 billion in 2023, growing at a CAGR of 5.74% during the forecast period from 2024 to 2030 to reach USD 6.20 billion by 2030. The global increase in the incidence of cardiovascular diseases (CVDs) due to lifestyle changes, smoking, lack of physical activities, excessive alcohol consumption, obesity, and other factors are escalating the global market of heart pump devices. Additionally, public health campaigns and initiatives aimed at raising awareness about cardiovascular health encourage individuals to undergo regular check-ups and screenings. Increased public knowledge about the importance of early detection and management of heart diseases leads to higher utilization of cardiovascular imaging services. Furthermore, key market players continuously investing in research and development to introduce innovative Heart Pump Devices, increased partnerships and collaborations, product launches, and approvals ensure that the market remains dynamic and innovative, during the forecast period from 2024 to 2030.
Zimmer Biomet Received FDA Clearance for OsseoFit™ Stemless Shoulder System for Total Shoulder Replacement
On December 13, 2024, Zimmer Biomet Holdings, Inc., a global leader in medical technology, announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the OsseoFit™ Stemless Shoulder System for total shoulder replacement. This innovative implant is designed to align with the natural anatomy of the humeral (upper shoulder) bone, optimizing anatomical fit while preserving healthy bone. The OsseoFit Stemless Shoulder System enhances the company’s extensive total shoulder portfolio and works in conjunction with the Identity® Humeral Heads featuring Versa-Dial® Technology for infinite offset placement, as well as the Alliance® Glenoid, offering a wide range of glenoid options to accommodate each patient’s unique anatomy.
“The OsseoFit Stemless Shoulder System combines an anatomically shaped implant1-3 which supports bone conservation and is designed for stable initial fixation4-7, with our proprietary OsseoTi® Porous Metal Technology for biological fixation,” said Brian Hatcher, President, SET & CMFT at Zimmer Biomet. “We are pleased to offer OsseoFit within our robust shoulder portfolio that includes modular, compatible components which provide surgeons with a multitude of options based on patients’ unique anatomy while maintaining a small instrument footprint and maximizing workflow efficiency.”
The anatomically designed left- or right-sided anchor implants feature fins that create a press-fit during insertion and include fully porous windows. The implant’s fin geometry and anchor spacing ensure proper orientation and fit into the natural bone, helping to avoid cortical impingement while reaching denser bone areas. Additionally, the design incorporates strategically placed anterior reattachment suture holes on the anchor to support subscapularis repair. The system comes in a single instrument tray, optimizing workflow and sterile processing efficiency, making it suitable for a variety of settings, including ambulatory surgical centers.
“As younger and more active patients require shoulder replacements, bone preservation becomes increasingly critical to accommodate potential revision procedures in the future,” said John W. Sperling, MD, MBA, Professor of Orthopedic Surgery at Mayo Clinic, and a member of the OsseoFit Stemless Shoulder System surgeon development team. “Using a method that mimics the asymmetry of the natural humerus enables surgeons to preserve native bone while optimizing fixation.”
As per DelveInsight’s “Shoulder Replacement Devices Market Report”, the shoulder replacement devices market was valued at USD 1.68 billion in 2023, growing at a CAGR of 7.27% during the forecast period from 2024 to 2030, to reach USD 2.54 billion by 2030. The shoulder replacement devices market is experiencing significant growth owing to the widespread instances of shoulder injuries and degenerative conditions like osteoarthritis and rheumatoid arthritis, the rise in product development & innovation activities, among others that are acting as key factors, contributing to the market growth of the shoulder replacement devices market during the forecast period from 2024 to 2030.
enVVeno Medical Successfully Completed Final Wave of Implants in Pre-Clinical GLP Study for enVVe
On December 16, 2024, enVVeno Medical Corporation, a company setting new standards of care for the treatment of venous disease, announced the successful completion of the final wave of implants for shorter-term subjects in its six-month pre-clinical GLP study for enVVe, its transcatheter-delivered replacement venous valve.
“With the successful completion of all planned implants in the enVVe GLP study, we have achieved the last of our milestones for 2024,” said Robert Berman, enVVeno Medical’s Chief Executive Officer. “Our enhanced enVVe crimping and delivery system has performed very well throughout the study and is ready for the pivotal trial. We will continue to monitor the performance of the enVVe valves throughout the remainder of the study and with successful data and pathology, should be in a position to file the IDE on schedule in mid 2025. We remain focused on our goal of becoming the established leader in both the surgical and non-surgical replacement venous valve markets for patients with severe deep venous CVI.”
The Company’s lead product is the VenoValve®, a potential first-in-class surgical replacement venous valve designed for patients with severe deep venous chronic venous insufficiency (CVI). In November, the Company submitted a PMA application to the U.S. Food and Drug Administration, seeking approval to market and sell the VenoValve in the U.S. The Company estimates that approximately 2.5 million new patients each year in the U.S. could be potential candidates for the VenoValve. Additionally, the Company is developing enVVe®, a next-generation transcatheter-based replacement venous valve, which could expand the market to include a larger pool of patients and physicians.
Starting early next year, the Company will begin executing its strategy to transition from a development-stage organization to a commercial entity for VenoValve, while also completing the required non-clinical and GLP testing for enVVe in preparation for its IDE application.
According to DelveInsight’s “Transcatheter Heart Valve Replacement Market Report”, the global transcatheter heart valve replacement market is estimated to grow at a CAGR of 13.75% during the forecast period from 2024 to 2030. The transcatheter heart valve replacement market is observing significant market growth primarily owing to the growing number of valvular heart diseases and aortic stenosis disorders across the globe. Further, the rising focus on minimally invasive surgeries, increasing technological advancements in device & surgical procedures, the increasing burden of the geriatric population prone to aortic stenosis, mitral regurgitation, and other cardiovascular disorders, increasing burden of risk factors leading to valvular diseases, presence of a large number of devices in the pipeline, increasing product launches and approvals, surging investments by key players, among others will ultimately affect the demand for transcatheter heart valve during the forecast period from 2024-2030 growing at a substantial CAGR.
