FDA Grants Breakthrough Device Status to TOBY’s Urine Test for Alzheimer’s Detection; ubtle Medical Achieves FDA Clearance for Next-Gen SubtleHD™(PET) Software; Ernest Health Expands Rehabilitation Network Through Reunion Hospitals Deal; Olympus Expands Prostate Cancer Footprint Through BioProtect Acquisition; ABILITY Neurotech Secures IMDD Approval for Clinical Trial of Chronic Brain-Computer Interface Implantation in ALS Patients; Implantica Reports Strong Economic Benefits of RefluxStop® in Italian GERD Treatment Study

TOBY Received FDA Breakthrough Device Designation for Its Urine-Based Alzheimer’s Disease Diagnostic Test 

On 26 May 2026, TOBY, Inc. announced that the U.S. Food and Drug Administration (FDA) had granted Breakthrough Device Designation to the TOBY Test for Alzheimer’s Disease. The designation recognized the test’s potential to support Alzheimer’s disease diagnosis using a simple, non-invasive urine sample while addressing the growing need for accessible cognitive evaluation and diagnostic solutions.

The TOBY Alzheimer’s Test was developed to assist in diagnosing Alzheimer’s disease by analyzing urinary volatile organic compound (VOC) patterns through mass spectrometry and proprietary machine learning technology. The company highlighted that Alzheimer’s diagnosis traditionally relied on specialist assessments, imaging procedures, cerebrospinal fluid testing, and emerging blood-based biomarkers, whereas TOBY was pursuing an alternative non-invasive diagnostic approach based on urinary VOC analysis.

Under the FDA-recognized proposed indication, the test was intended for adults aged 50 years and older showing symptoms of cognitive impairment and undergoing evaluation for Alzheimer’s disease. The company stated that test results were designed to be interpreted alongside other clinical findings and patient information.

The Alzheimer’s disease designation marked TOBY’s third FDA Breakthrough Device Designation, further expanding the company’s portfolio across oncology and central nervous system (CNS) disease diagnostics. The achievement also strengthened TOBY’s broader strategy focused on urine-based molecular diagnostic technologies.

The FDA’s Breakthrough Devices Program was established to accelerate the development and regulatory review of technologies that could improve the diagnosis or treatment of life-threatening or severely debilitating diseases. Following the designation, TOBY stated that it would continue conducting clinical validation studies and collaborate closely with the FDA during future regulatory and development activities.

“This designation further validates the potential of urinary VOC patterns as an entirely new diagnostic modality,” said Matthew Laskowski, Founder and CEO of TOBY. “For the millions of individuals and families living in the shadow of Alzheimer’s disease, the need for earlier, simpler and more accessible detection has never been greater. This milestone reflects our commitment to the patients and families who deserve earlier and easier answers.”

As per DelveInsight’s “Alzheimer’s Disease Diagnostic Market Report,” the global Alzheimer’s disease (AD) diagnostic market will grow at a CAGR of 10.97% during the forecast period from 2024 to 2030. The Alzheimer’s disease (AD) diagnostic market is observing an optimistic market growth due to factors such as a rise in the regulatory approvals for Alzheimer’s disease (AD) diagnostics across the globe. Further, the rising prevalence of head injuries owing to accidents, workplace injuries, and others, and the rise in the geriatric population will increase the prevalence of Alzheimer’s disease, thereby increasing the demand for Alzheimer’s disease diagnostic devices across the globe. Additionally, the increasing research and development of novel biomarkers, the presence of key players in the market, increasing product launches and approvals, and other factors will create a need for Alzheimer’s disease diagnostics in the upcoming years. Therefore, the market for Alzheimer’s disease (AD) diagnostics is estimated to grow at a substantial CAGR during the forecast period from 2024 to 2030.

Subtle Medical Received FDA Clearance for SubtleHD™(PET), Next-Generation AI-Powered Image Acceleration and Enhancement Software 

On 27 May 2026, Subtle Medical announced that it had received FDA clearance for SubtleHD™(PET), its advanced AI-powered PET image enhancement software developed to improve image quality and accelerate PET imaging workflows across PET/CT and PET/MR systems. The company noted that approximately 4.5 million PET scans were performed globally each year, while demand for PET imaging continued to rise due to the increasing use of new radiotracers and theranostic applications. Industry data also indicated that a majority of PET imaging centers expected procedure volumes to increase over the following year, creating pressure on healthcare providers to improve workflow efficiency and maximize scanner utilization.

The FDA clearance expanded Subtle Medical’s presence in the PET imaging market, particularly among imaging centers using advanced radiotracers, theranostics programs, and healthcare systems operating in-house cyclotrons. The newly cleared SubtleHD™(PET) solution was developed using advanced AI model architecture and delivered enhanced image quality, improved SUVmax quantitation accuracy, and broader compatibility with all FDA-approved radiotracers, including emerging molecular imaging agents beyond conventional 18F-FDG imaging.

The software was validated using accelerated low-count PET acquisitions and included customizable denoising settings based on radiologist preferences. It also utilized anatomical CT data to improve PET image reconstruction quality and quantitative consistency. The company stated that shorter PET scan durations could improve patient comfort, especially for oncology, elderly, pediatric, and critically ill patients who often experience difficulties during lengthy imaging procedures. Additionally, imaging providers benefited from improved workflow efficiency and increased patient throughput, which could help generate additional revenue opportunities. SubtleHD™(PET) became part of Subtle Medical’s broader AI imaging portfolio covering MRI, PET, and CT imaging technologies. The company further stated that it was developing an integrated AI Imaging Hub aimed at enhancing imaging workflows, improving operational efficiency, standardizing imaging quality, expanding patient access, and supporting enterprise-wide AI adoption across healthcare systems.

“PET imaging demand continues to grow globally, but providers remain constrained by scanner capacity, long scan times, and operational inefficiencies,” said Ajit Shankaranarayanan. “SubtleHD™(PET) brings the latest advances in AI imaging to help address these issues and helps imaging providers improve throughput, drive new revenue, increase patient access, and maximize the value of existing PET infrastructure while delivering faster, more comfortable imaging experiences for patients.”

As per DelveInsight’s “Artificial Intelligence (AI) in Medical Imaging Market Report,” the global artificial intelligence in medical imaging market is expected to increase from USD 1,673.03 million in 2024 to USD 13,181.93 million by 2032, growing at a CAGR of 29.48% during the forecast period from 2025 to 2032. The global artificial intelligence in medical imaging market is being driven by the rising prevalence of chronic diseases such as cancer, cardiovascular disorders, and neurological conditions, which increase demand for accurate and efficient diagnostics. Government initiatives and funding are promoting healthcare digitization and AI adoption, while key players are investing in product development and strategic collaborations to enhance imaging solutions. Rapid advancements in deep learning, machine learning, and computer vision are further improving diagnostic accuracy, workflow efficiency, and predictive capabilities, collectively accelerating market growth across regions.

Ernest Health Acquired Reunion Rehabilitation Hospitals, Expanding National Network 

On 27 May 2026, Ernest Health, a leading provider of post-acute rehabilitation services in the United States, announced that it had entered into a definitive agreement to acquire Reunion Rehabilitation Hospitals. Reunion Rehabilitation Hospitals operated a network of seven medical rehabilitation hospitals across Arizona, Colorado, Texas, and Florida.

Following the acquisition, Ernest Health expanded its network from 38 to 45 medical rehabilitation hospitals nationwide. The facilities specialize in providing rehabilitative treatment for patients suffering from disabilities caused by injuries, chronic illnesses, and other medical conditions.

The company stated that the transition process was expected to take place smoothly over the following months without affecting hospital operations or patient services. Employees of Reunion Rehabilitation Hospitals were offered opportunities to continue working within the Ernest Health organization.

After joining Ernest Health, the hospitals continued operating under a locally managed hospital model, enabling each facility to address the unique healthcare needs of its community while benefiting from shared expertise, clinical protocols, and organizational innovations across the network.

“The acquisition reinforces Ernest Health’s commitment to advancing post-acute rehabilitative care through innovation, quality, and compassion,” says Jake Socha, President and CEO of Ernest Health. “Reunion Rehabilitation Hospitals’ mission and culture align with ours at Ernest Health, as we continue to deliver exceptional outcomes, maintain clinical and operational consistency, and preserve our culture of accountability and performance.”

As per DelveInsight’s “Medical Rehabilitation Services Market Report,” the global medical rehabilitation services market size was estimated at USD 270.91 billion in 2024 and is projected to reach USD 386.92 billion by 2030, growing at a CAGR of 6.2% from 2025 to 2030. An increasing number of patients with neurological, musculoskeletal, and cardiologic conditions is expected to drive the growth of the market over the forecast.

Olympus to Acquire BioProtect to Expand Its Portfolio of Urological Technologies and Address Prostate Cancer 

On 26 May 2026, Olympus Corporation announced that it had signed a definitive agreement to acquire BioProtect Ltd. as part of its strategy to strengthen its oncology and urology portfolio. The acquisition, valued at approximately $270 million, was expected to be completed by the end of the second quarter of calendar year 2026, subject to customary closing conditions and escrow arrangements tied to continued business operations.

BioProtect specializes in implantable technologies designed to improve prostate cancer treatment and patient quality of life. The company’s flagship Balloon Spacer system was developed to create stable spacing between the prostate and nearby critical tissues during radiation therapy, helping protect healthy organs from radiation exposure. After treatment completion, the implant naturally biodegraded within the body.

Since its commercial launch in 2023, the Balloon Spacer system had been utilized in more than 11,000 procedures globally. Clinical studies suggested that the technology contributed to preserving gastrointestinal, urinary, and sexual functions in patients undergoing prostate cancer radiation therapy.

For Olympus, the acquisition aligned with its innovation-driven growth strategy and broader focus on expanding advanced cancer care solutions. The company emphasized that prostate cancer remained the second most commonly diagnosed cancer among men worldwide, with approximately 1.5 million new cases diagnosed annually.

The transaction also supported Olympus’ efforts to expand into adjacent therapeutic areas connected to endoscopy, particularly within gastrointestinal and urological care. In addition, the company stated that the global rectal spacer market was expected to experience significant growth over the next decade, further strengthening the strategic value of the acquisition.

“We are pleased to welcome BioProtect to Olympus,” said Seiji Kuramoto, Executive Officer and Surgical and Interventional Solutions Division Head at Olympus. “BioProtect brings a highly differentiated solution to prostate cancer care, with a compelling clinical value proposition and early commercial success. By combining BioProtect’s strengths with Olympus’ global reach and relationships with healthcare professionals, we believe we can expand access to solutions that support better patient outcomes and help clinicians to advance the treatment of prostate cancer.”

According to DelveInsight’s “Urology Devices Market Report”, the global urology devices market is expected to increase from USD 34,898.97 million in 2024 to USD 63,320.19 million by 2032, growing at a CAGR of 7.77% during the forecast period from 2025 to 2032. The global urology devices market is growing due to the rising prevalence of kidney stones, urinary incontinence, BPH, and prostate and bladder cancers, particularly among the aging population. Advancements in minimally invasive and robotic-assisted procedures, along with improved diagnostics, are boosting adoption. Additionally, increasing healthcare spending, expanding infrastructure in emerging economies, and rising lifestyle-related risk factors such as obesity and diabetes are further driving market demand.

ABILITY Neurotech Received IMDD Approval to Start Clinical Trial for Chronic Implantation of Brain-Computer Interface in ALS Patients

On 26 May 2026, ABILITY Neurotech announced that it had received Investigational Medical Device Dossier (IMDD) approval from the Medical Research Ethics Committee (MREC) NedMec in the Netherlands to begin the first chronic implantation study of its fully implantable wireless optical-link electrocorticography (ECoG) brain-computer interface (BCI) in patients with amyotrophic lateral sclerosis (ALS).

The approval represented a significant milestone for the company, allowing ABILITY Neurotech to transition from intra-operative testing to long-term clinical investigation. It also marked the first extended human use of the company’s implantable BCI platform. The approval confirmed that the company had successfully met European Medical Device Regulation (MDR) requirements related to preclinical testing, biocompatibility, safety, software validation, and risk management. The clinical study was planned to take place at UMC Utrecht under the INTRECOM consortium, which included UMC Utrecht, the Technical University of Graz in Austria, ABILITY Neurotech, and CorTec.

The study involved implanting ABILITY’s BCI system in ALS patients to evaluate its effectiveness as a home-use platform for restoring communication and speech capabilities. The company stated that the broader goal of the technology was to support long-term neural communication and improve independence for patients with severe neurological impairments.

ABILITY’s platform was designed for long-term sub-scalp implantation and high-fidelity brain signal collection. The system transmitted raw neural data using a wireless infrared optical link and was developed to convert neural intent directly into digital actions such as autonomous text generation, assistive technology control, and real-time communication through thought-driven interaction.

The company further stated that the platform operated using a 50 Mb/s transcutaneous optical link capable of streaming high-resolution broadband neural data at a level of fidelity not previously achieved in a fully implantable, battery-free BCI device. According to ABILITY Neurotech, the technology was intended to create a scalable neural data infrastructure capable of supporting future AI-powered brain-computer interface applications.

“Receiving approval for our first chronic implantation study is a defining moment for both ABILITY and for the broader BCI field,” said Rotem Kopel, PhD, CEO of ABILITY Neurotech. “The industry has long focused on proving neural interfaces can work in controlled environments. This study moves the field significantly in the direction of delivering a practical and scalable system patients can use independently in everyday life. It validates our belief that the future of BCI lies in the fully implantable, data rich, patient-centric platform engineered by ABILITY for long-term real-world use.”

According to DelveInsight’s ”Implanted Brain-Computer Interface Devices Market Report,” the implanted brain-computer interface (BCI) devices market is estimated to grow at a CAGR of 10.42% during the forecast period from 2025 to 2032. The demand for implanted brain-computer interface (BCI) devices is significantly driven by the increasing prevalence of neurological and movement disorders and a rising number of patients experiencing hearing and vision loss. Additionally, the growing adoption of digital health solutions is reshaping the landscape of patient care, further fueling market growth. Key factors contributing to this upward trend include increasing research and development activities and strategic collaborations among leading players to develop more advanced BCI devices. These developments are expected to play a pivotal role in propelling the implanted BCI devices market during the forecast period from 2025 to 2032.

Implantica Announced Publication of a New Health Economics Study Showing Refluxstop®’S Superior Cost-Effectiveness in the Treatment of GERD in the Italian Healthcare System 

On 21 May 2026, Implantica AG announced that a new study had demonstrated that its innovative GERD treatment device, RefluxStop, was highly cost-effective compared to conventional GERD treatments within the Italian healthcare system. The study, titled “Cost-effectiveness of RefluxStop for gastroesophageal reflux disease: analysis from an Italian healthcare perspective,” was conducted by the York Health Economics Consortium in collaboration with leading Italian anti-reflux surgeons and was published in BMC Gastroenterology.

The health-economic analysis showed that RefluxStop® had a 100% probability of being cost-effective compared with proton pump inhibitors (PPIs) and magnetic sphincter augmentation (MSA), along with a 97% probability compared with Nissen fundoplication in Italy’s healthcare system. The company also reported that more than 200 procedures had already been completed, while increasing approvals of public tenders across Italy had strengthened the commercial adoption of RefluxStop®. The positive reimbursement outlook in Italy was expected to support wider adoption across other European healthcare markets as well.

Inventor of RefluxStop® and CEO of Implantica, Dr. Peter Forsell says, “The basis for a successful launch of a new treatment always depends on good or superior clinical results; however, the power of having the most cost-effective treatment should not be underestimated. Italy is a good example where health economics, with RefluxStop being the most cost-effective treatment available, goes hand in hand with securing procurement in the public healthcare system. We are grateful to the independent surgeons who choose to collect and publish RefluxStop® data, driving surgical innovation forward for GERD patients everywhere.”

According to DelveInsight’s “Gastroesophageal Reflux Disease (GERD) Devices Market Report,” the global gastroesophageal reflux disease (GERD) devices market is estimated to grow at a CAGR of 9.20% during the forecast period. The demand for gastroesophageal reflux disease (GERD) devices is primarily being boosted by the rising number of patients suffering from obesity owing to the sedentary lifestyle, increasing technological advancements associated with the GERD devices, and the rising geriatric population susceptible to developing the GERD disorder, contributing to the overall market growth of the gastroesophageal reflux disease (GERD) Devices during the forecast period from 2024 to 2030.