Marnix Lam, MD, Professor of Nuclear Medicine at UMC Utrecht commented, “PSMA-PET has had a profound impact on prostate cancer imaging, providing greater precision and confidence in diagnosis, staging and management of disease, compared to conventional imaging. The approval of Telix’s PSMA-PET agent in the Netherlands means that more hospitals will be able to integrate this innovative technology into routine clinical practice for the benefit of patients.”
PSMA-PET imaging represents a significant advancement in prostate cancer management, offering superior accuracy over conventional imaging methods such as bone scans and CT scans. It is quickly becoming the standard of care for both primary disease staging and the evaluation of biochemical recurrence (BCR). With this approval, Illuccix® helps meet a critical need by providing timely and effective diagnosis and facilitating patient selection for treatment with PSMA-targeted therapies.
As per DelveInsight’s “Prostate Cancer Diagnostics Market Report”, the prostate cancer diagnostics market is estimated to grow at a CAGR of 12.45% during the forecast period from 2024 to 2030. The demand for prostate cancer diagnostics is primarily being boosted by the increasing incidence of prostate cancer, increasing awareness and screening programs, and growing advancement in diagnostic technologies, during the forecast period from 2024 to 2030.
Valcare Medical Received FDA Approval to Initiate an Early Feasibility Study for its Novel Amend™ Trans-Septal System
On March 13, 2025, Valcare Medical Inc., a leading innovator in transcatheter-based mitral solutions, announced that the U.S. Food and Drug Administration (FDA) had approved the AMEND™ Trans-Septal System for an investigational device exemption (IDE) application to commence an Early Feasibility Study (EFS).
The AMEND™ Trans-Septal System was designed as a transcatheter device intended for the treatment of mitral insufficiency, featuring a semi-rigid, closed, D-shaped annuloplasty ring that mimics the surgical gold standard.
The EFS study aimed to evaluate the safety and functionality of the AMEND™ Trans-Septal System in treating subjects with symptomatic moderate-to-severe (3+) or severe (4+) functional mitral regurgitation (FMR) who were anatomically suitable for transcatheter mitral annuloplasty. The study planned to enroll up to 15 subjects across seven investigational centers in the United States. Patient treatment was expected to begin in the first half of 2025, paving the way for a pivotal study anticipated in 2027.
The primary and secondary endpoints of the trial included safety and device performance assessments such as the technical success of ring delivery, implantation, and delivery system retrieval. Patient outcomes, including stroke, myocardial infarction, non-elective cardiovascular surgery for device-related complications, and all-cause mortality, were set to be reported at 30 days and six months post-implantation.
Additional secondary endpoints included changes in NYHA functional class, 6-Minute-Walk-Test results, and quality of life assessments at 30 days and six months, along with a reduction in MR grade from baseline by at least one grade at 30 days, six months, and one year.
“I am pleased and eager to begin the AMEND™ Trans-Septal System EFS to further evaluate this promising novel technology. The AMEND™ annuloplasty ring has the potential to improve mitral repair for a patient population that are considered poor candidates for currently available therapies,” stated Dr. Scott Lim, AMEND EFS Study Chairman and Professor of Medicine & Pediatrics at the University of British Columbia, and Professor Emeritus with Tenure at the University of Virginia. “Furthermore, the AMEND System provides a non-invasive approach to the gold standard surgical repair, and I am excited for its potential to treat patients suffering from severe mitral regurgitation.”
As per DelveInsight’s “Transcatheter Mitral Valve Repair Devices Market Report”, the global transcatheter mitral valve repair devices market was valued at USD 1,197.06 million in 2023, growing at a CAGR of 14.95% during the forecast period from 2024 to 2030 to reach USD 2,756.71 million by 2030. The transcatheter mitral valve repair devices market is expanding rapidly due to the growing prevalence of cardiovascular disorders including circulatory diseases, various heart valve diseases, increasing product developmental activities such as regulatory clearances, rising sedentary lifestyle & lifestyle-associated disorders, increasing preference for minimally invasive surgeries that are expected to escalate the overall growth of the transcatheter mitral valve repair devices market during the forecast period from 2024 to 2030.
RevBio Initiated its Pivotal Clinical Trial in Europe for its Dental Implant Stabilization Product
On March 17, 2025, RevBio, Inc. announced that it received regulatory and ethics committee approvals in multiple European countries to conduct its pivotal clinical trial for its dental implant stabilization product. The successful completion of this trial would result in CE marking approval for the product, enabling the company to begin commercial sales in Europe. As of the date of the press release, the company had already enrolled 30 of the expected 75 patients in the trial.
RevBio received regulatory and ethics committee approvals for five clinical sites, including one in Switzerland, two in Belgium, one in Spain, and one in the United Kingdom. Each site was expected to enroll between 12 and 25 patients, totaling approximately 75 patients. The investigators approved to enroll patients in this clinical trial included Prof. Dr. med. Dent., PhD, Patrick Schmidlin, Head of the Department of Periodontology at the University of Zurich; Ana Castro, BDS, MSc, PhD, Clinical Head of the Department of Periodontology at the Catholic University of Leuven; France Lambert, DDS, PhD, Professor and Head of Periodontology, Oral Surgery, and Implant Surgery at the University of Liège; Arturo Llobell, DDS, MS, a periodontist in private practice in Valencia, Spain; and Azim Malik, BDS, MFDS RCSEd, DipPCD RCSI, DClinDent, MPerio RCSEd, a periodontist and implant specialist in private practice in London, United Kingdom.
When teeth were extracted due to damage from traumatic injuries, tooth decay, or gum disease, the standard of care consisted of multiple staged surgical procedures to restore a patient’s dentition with prosthetic crowns supported by dental implants. Frequently, extraction sites were too large for dental implants to achieve primary stability through conventional mechanical engagement. Instead, patients had to undergo a costly, complex, and lengthy process, including a preliminary bone grafting surgery before receiving a dental implant. The use of TETRANITE to stabilize an unstable implant allowed for the immediate placement of dental implants that otherwise could not have been placed until the initial bone graft had healed to form new bone. As a result, the TETRANITE® biomaterial helped reduce the duration and complexity of these dental implant procedures, lessened patient pain and recovery time, and lowered the overall cost of care, thereby providing greater patient access to the treatment of tooth loss.
“The results from this ongoing international multicenter study are exceeding expectations, showcasing remarkable outcomes. We are profoundly optimistic and incredibly enthusiastic about what the future holds,” said Prof. Dr. med. Dent., Patrick Schmidlin, head of the Division of Periodontology at the University of Zurich, who serves as one of the investigators in RevBio’s pivotal clinical trial. “This breakthrough material promises to open a new chapter in dental care, redefining what is possible in regenerative dentistry.”
“The approval to conduct this pivotal clinical trial and the successful enrollment of the first 30 patients is a watershed moment for RevBio,” said Alan Pollack, DDS, RevBio’s Senior Director of Dental Clinical Operations. “This clinical trial has the potential to significantly accelerate the timeframe when this promising bone adhesive technology can be used in the field of dentistry.”
According to DelveInsight’s “Dental Implants Market Report”, The global dental implants market was valued at USD 5,126.50 million in 2023, growing at a CAGR of 9.36% during the forecast period from 2024 to 2030 to reach USD 8,589.40 million by 2030. The increased tooth loss and tooth decay owing to age, bad eating habits, poor oral hygiene, and accidents are going to increase the demand for dental implants. Further, increased demand for cosmetic dentistry, the extended application of computer-aided design technology in implant dentistry, and increased demand for aesthetic restoration across the world are also anticipated to bolster the market, thereby contributing to the growth of the overall dental implants market during the forecast period from 2024 to 2030.
Insulet’s RADIANT Trial Demonstrated Meaningful Glycemic Improvements with the Omnipod® 5 Automated Insulin Delivery System Following Direct Transition from Multiple Daily Injections
On March 19, 2025, Insulet Corporation, a global leader in tubeless insulin pump technology with its Omnipod® brand, shared new clinical data from its RADIANT study at the 18th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Amsterdam, the Netherlands. The RADIANT study, a multinational randomized controlled trial, evaluated the direct transition from multiple daily injections (MDI) to an automated insulin delivery (AID) system in adults and children with type 1 diabetes. This study is also the first to assess the safety and efficacy of an AID system paired with the Abbott FreeStyle Libre® 2 sensor.
The results showed that for adults and children who had not previously met clinical targets for HbA1c while on MDI, the Omnipod 5 AID System provided clinically significant improvements in HbA1c compared to MDI with a continuous glucose monitor (CGM). Despite advancements in diabetes technology, MDI remained the dominant therapy for type 1 diabetes, and many patients using MDI plus CGM had not achieved the recommended HbA1c goal of less than 7%. In the U.S., the average HbA1c level for these patients was reported to be 8.7%, which increases the risk of diabetes-related complications.
The RADIANT study involved 188 participants aged 4 to 70 years with type 1 diabetes, all of whom had been using MDI with CGM for at least three months. Participants, recruited from clinical centers in France, the U.K., and Belgium, were randomized to either start using the Omnipod 5 AID System (N=125) or continue with their usual MDI plus CGM therapy (N=63) for three months.
Participants began with an average HbA1c level of 8.1%. After three months, those who used the Omnipod 5 System improved their HbA1c by an average of 0.8% compared with those using MDI plus CGM, resulting in a final HbA1c of 7.2%. For those who started with an HbA1c level above 8.0%, the benefit was even greater, with an improvement of 1.0% compared with MDI plus CGM. Lowering HbA1c by this amount was associated with a reduced risk of developing future diabetes complications, such as cardiovascular disease, kidney disease, and eye problems.
“Omnipod 5 is changing the lives of an estimated 365,000 users worldwide by eliminating the need for injections and reducing the burden of diabetes. Results from this randomized controlled trial build on our previous studies and once again clearly demonstrate the significant therapeutic benefits for people who require insulin to live and switch from injections to Omnipod 5,” said Dr. Trang Ly MBBS, FRACP, PhD, Insulet Senior Vice President and Chief Medical Officer.
In addition to improving their HbA1c, Omnipod 5 users spent an additional 5.4 hours per day with glucose levels in the target range (70-180mg/dL) compared with MDI plus CGM users, resulting in a final average time in range of 65%, up from 39% at baseline. This was accompanied by significantly less time per day with high glucose levels (>180mg/dL and >300mg/dL), and no increase in time spent with dangerously low glucose (<70mg/dL or <54mg/dL). There were no life-threatening acute events involving severe hypoglycemia or diabetes-related ketoacidosis in either treatment group during the three-month study.
According to DelveInsight’s “Insulin Delivery Device Market Report”, the global insulin delivery devices market was valued at USD 15.51 billion in 2023, growing at a CAGR of 9.28% during the forecast period from 2024 to 2030, to reach USD 26.35 billion by 2030. The rise in demand for insulin delivery devices is predominantly driven by the increasing prevalence of diabetes due to lifestyle changes, aging populations, and genetic factors. Secondly, awareness campaigns and educational initiatives have significantly increased public knowledge about diabetes management. Patients and healthcare providers are now more informed about the benefits of using advanced insulin delivery devices, which offer precise dosing, convenience, and improved blood glucose control compared to traditional methods. Additionally, technological advancements have further fueled market growth by introducing innovative features such as smart insulin pumps, continuous glucose monitor (CGM) integration, and mobile app connectivity. Collectively, these factors create a robust market environment that drives the demand for insulin delivery devices, ensuring better health outcomes for diabetes patients, during the forecast period from 2024 to 2030.
Envoy Medical Secured $10 Million in Funding to Advance the Pivotal Clinical Trial of its Breakthrough Hearing Device
On March 12, 2025, Envoy Medical®, Inc., a company specializing in fully implanted hearing devices, announced that it had secured $10 million in financing from its largest existing shareholder, billionaire entrepreneur Glen Taylor. The financing provided the company with access to additional capital during what it anticipated to be a transformative year with several important milestones. The funds were designated to maintain the company’s momentum through its fully implanted Acclaim® cochlear implant pivotal clinical trial and support other operations.
The $10 million lending facility had a five-year term, was unsecured, did not include a conversion feature, and deferred interest for the first two years. Funds were made available as needed and bore interest at 8% over the loan term. For additional details on the terms and conditions of the investment, please refer to the Current Report on Form 8-K filed by Envoy Medical.
“We are very happy with the enrollment progress in the first stage of our pivotal clinical trial,” said Envoy Medical CEO Brent Lucas, “Investigational sites are reporting a tremendous amount of interest in our fully implanted cochlear implant. We believe that interest will only grow as awareness is increased and further progress is made. We are bullish on the reported desire of many cochlear implant candidates to have a device that is designed to be completely internal.”
According to DelveInsight’s “Cochlear Implants Market Report”, The cochlear implants market was valued at USD 1.38 billion in 2023, growing at a CAGR of 9.92% during the forecast period from 2024 to 2030 to reach USD 2.43 billion by 2030. The cochlear implants market is observing substantial market growth primarily owing to the increasing prevalence of hearing loss & incurs substantial economic costs, investing in cochlear implants & improving access to these devices and supportive reimbursement policies are anticipated to further accelerate the overall growth of the cochlear implants market during the forecast period from 2024 to 2030.
Vave Health Introduced the World’s First Wireless, Handheld, Whole-Body Ultrasound with a Single PZT Transducer
On March 13, 2025, Vave Health announced the launch of its Universal Wireless Probe, an innovative device designed to improve efficiency, accuracy, and diagnostics across various clinical and educational settings. Combining linear and phased imaging technology, the probe provides high-quality, full-body imaging without the burden of ongoing subscription fees or hidden costs.
By simplifying and reducing the cost and complexity of existing point-of-care ultrasound (POCUS) technologies, Vave is pushing the market toward greater adoption of medical imaging where it is most needed. The Universal Wireless Probe is an affordable yet powerful solution that is easy to use, offering a range of presets to empower healthcare professionals with the tools they need to provide enhanced care, anytime and anywhere.
“A combination of wireless portability, lack of subscription and membership fees, life-time software updates, full-body imaging, and rich educational support, make the Vave solution the ideal platform for new learners and seasoned POCUS users alike,” stated Dr. Renee Dversdal, Chief Medical Officer at Vave Health.
In addition to its gold-standard PZT transducer technology, the Vave Universal Probe is specifically engineered for portability. The device features a patented probe head cover and a swappable battery, which minimize downtime and ensure seamless, continuous operation, making it ideal for on-the-go use in a variety of clinical environments. This design ensures that healthcare professionals can rely on the probe for consistent and efficient performance, even in high-demand settings.
According to DelveInsight’s “Ultrasound Devices Market Report”, the global ultrasound devices market was valued at USD 6.76 billion in 2023, growing at a CAGR of 6.82% during the forecast period from 2024 to 2030 to reach USD 10.05 billion by 2030. The ultrasound devices market is witnessing positive growth owing to the rising incidence of severe chronic diseases such as cardiovascular, urology, and others, further rapid technological developmental activities, growing awareness for early disease detection, and increasing geriatric population across the globe who are more susceptible to developing chronic disorders, and rising adoption owing to no radiation exposure, thereby contributing to the growth of the ultrasound devices market during the forecast period.
