UTR Therapeutics’ UTRxMYCN M1-14 Granted FDA Orphan Drug and Rare Pediatric Disease Designations; Medtronic Announces Regulatory Milestones for New Cardiac Mapping and Ablation Software; Abbott Adds SimpleScreen™ CRC Blood Test to Colorectal Cancer Screening Portfolio; VEMERIX Introduces Patented Single-Use Ultrasound Puncture Kit With Customized Probe Compatibility; Avisi Technologies to Showcase Two-Year VisiPlate® Results at AAO Annual Meeting; FIRE1 Implants First Patient in NORM-HF Pivotal Trial for Innovative Heart Failure Management

UTR Therapeutics Inc. Announced U.S. FDA Orphan Drug Designation and Rare Pediatric Disease Designation for UTRxMYCN M1-14

On 29 September 2026, UTR Therapeutics Inc. announced that the U.S. FDA had granted Orphan Drug Designation to UTRxMYCN M1-14 for the treatment of soft tissue sarcoma, including rhabdomyosarcoma, and Rare Pediatric Disease Designation for rhabdomyosarcoma. The investigational therapy was based on the company’s RNA Overwriting technology, which was designed to target oncogenic messenger RNA associated with MYCN and promote its degradation while preserving healthy messenger RNA. 

Preclinical studies had demonstrated dose-dependent MYCN inhibition, tumor growth suppression, and reductions in liver and lung metastasis in MYCN-driven rhabdomyosarcoma models. The designations supported the continued development of UTRxMYCN M1-14 for aggressive sarcomas, particularly pediatric rhabdomyosarcoma, where treatment options remained limited. The development also highlighted the growing application of RNA-based therapeutic approaches in cancers driven by transcription factors that had been difficult to address using conventional drug modalities.

“The ODD and RPDD designations granted to UTRxMYCN M1-14 by the U.S. FDA validate the UTR Therapeutics platform technology and the potential of UTRxMYCN M1-14 to address several aggressive sarcomas that represent serious unmet needs in the U.S. and worldwide,” said David T. Asuzu, M.D., Chief Medical Officer.

As per DelveInsight’s “RNA Therapeutics Market Report,” the global RNA therapeutics market size is expected to increase from USD 19,737.64 million in 2025 to USD 56,071.08 million by 2034, reflecting strong and sustained growth. The global RNA therapeutics market is growing at a CAGR of 12.36% during the forecast period from 2026 to 2034. The RNA therapeutics market is witnessing strong growth due to a combination of rising disease burden and technological advancement in drug development. The increasing global patient pool affected by infectious diseases and genetic disorders is significantly driving demand for targeted and precision-based treatment options offered by RNA-based therapies. Additionally, the heightened need for rapid and effective protection against sudden pandemic outbreaks, as demonstrated during COVID-19, has accelerated the adoption of mRNA vaccine platforms. Furthermore, the growing number of ongoing clinical trials across oncology, rare diseases, and infectious diseases is expanding the pipeline of RNA therapeutics, enhancing innovation, and increasing the likelihood of future approvals. Collectively, these factors are driving strong momentum and long-term growth in the global RNA therapeutics market.

Medtronic Announced Regulatory Milestones for Newest Cardiac Mapping and Ablation Software 

On 30 September 2026, Medtronic announced regulatory milestones for its cardiac mapping and ablation software portfolio, including FDA clearance and CE Mark for the latest Affera Prism-2 Mapping Software and CE Mark for the PulseSelect ProxBox Adapter with Proximity Indicator software. The Prism-2 software expanded three-dimensional cardiac mapping capabilities by enabling physicians to visualize and analyze the heart’s electrical activity during ablation procedures. Its enhancements included beat matching, pace tagging, and improvements to the system’s internal pacing capabilities. The software was used with the Affera Mapping and Ablation System and Sphere-9 Catheter, which combined cardiac mapping with pulsed field and radiofrequency ablation. Separately, the PulseSelect ProxBox Adapter provided real-time, impedance-based feedback to help assess catheter proximity to targeted heart tissue before energy delivery. These regulatory developments expanded Medtronic’s integrated mapping and ablation capabilities for patients with heart rhythm disorders.

“We spent four years fixing the part of ultrasound-guided puncture that the imaging console cannot fix, holding the needle in the plane the operator is watching,” said Lily (Lianhua) Nan, Founder of Weihai Medison Medical Equipment Co., Ltd. and a named inventor on the patent. “And overseas customers do not need our ultrasound to use it: we customize the guide to match the probes they already run.”

As per DelveInsight’s “Cardiac Ablation Devices Market Report,” the global cardiac ablation devices market is expected to increase from USD 3,832.19 million in 2024 to USD 10,317.88 million by 2032, reflecting strong and sustained growth. The global cardiac ablation devices market is growing at a CAGR of 13.25% during the forecast period from 2025 to 2032. The cardiac ablation devices market is witnessing strong growth, driven by the rising prevalence of cardiovascular disorders, especially atrial fibrillation, and growing patient preference for minimally invasive procedures. Advances in technology, including radiofrequency and cryoablation systems, contact force-sensing catheters, and pulsed field ablation, are improving precision, safety, and outcomes. With manufacturers developing next-generation platforms integrating imaging, mapping, and AI guidance, these factors are expected to sustain robust market expansion in the coming years.

Abbott Launched SimpleScreen™ CRC Blood Test, Joining Cologuard Plus® in its Colorectal Cancer Screening Portfolio 

On 30 September 2026, Abbott launched SimpleScreen CRC in the U.S., expanding its colorectal cancer screening portfolio with an FDA-approved blood-based screening test. The test was developed and manufactured by Freenome and was exclusively commercialized by Abbott. It was designed for average-risk adults aged 45 and older and used circulating cell-free DNA obtained through a blood draw to identify signals associated with colorectal cancer. The test was evaluated in the PREEMPT CRC study, which included more than 48,000 asymptomatic, average-risk adults. 

The study demonstrated 81.1% overall sensitivity for colorectal cancer and 90.4% specificity for advanced colorectal neoplasia in a prespecified U.S. Census-adjusted analysis. SimpleScreen CRC was also covered by Medicare, with eligible Medicare Part B patients having no out-of-pocket costs. The launch expanded access to blood-based colorectal cancer screening and strengthened Abbott’s presence in the colorectal cancer diagnostics market.

As per DelveInsight’s “Cancer Diagnostics Market Report,” the global cancer diagnostics market was valued at USD 125.13 billion in 2023, growing at a CAGR of 9.43% during the forecast period from 2024 to 2030, to reach USD 214.88 billion by 2030. The increase in demand for cancer Diagnostics products and services is predominantly attributed to the spike in cancer cases reported worldwide. In addition, growing manufacturers’ focus to develop advanced cancer diagnostic products, the establishment of various cancer diagnostic labs, and rising government initiatives to raise awareness regarding early detection and management of cancer among patients, and others are anticipated to drive the global cancer diagnostics market during the forthcoming years.

VEMERIX Launched Patented Single-Use Ultrasound Guidance Puncture Kit With Probe-Matched Customization  

On 30 September 2026, VEMERIX, the medical device brand of Weihai Medison Medical Equipment Co., Ltd., launched its patented Ultrasound Guidance Puncture Kit for international markets. The sterile, single-use device was designed to secure an ultrasound probe and puncture needle and facilitate real-time, in-plane visualization during needle advancement. 

The kit was available in four configurations and 45 size codes, ranging from a needle-guide bracket to a more comprehensive procedure kit containing additional sterile components. The device had been registered as a Class II medical device in China and was supported by a Chinese invention patent. VEMERIX also offered probe-matched customization, allowing the guide to be configured for ultrasound probes already used by customers. The company targeted distributors, private-label partners, and ultrasound manufacturers, while availability in international markets remained subject to local regulatory requirements.

“We spent four years fixing the part of ultrasound-guided puncture that the imaging console cannot fix, holding the needle in the plane the operator is watching,” said Lily (Lianhua) Nan, Founder of Weihai Medison Medical Equipment Co., Ltd. and a named inventor on the patent. “And overseas customers do not need our ultrasound to use it: we customize the guide to match the probes they already run.”

According to DelveInsight’s “Ultrasound Devices Market Report”, the global ultrasound devices market size is expected to increase from USD 9,315.06 million in 2024 to USD 13,054.68 million by 2032, reflecting strong and sustained growth. The global ultrasound devices market is growing at a CAGR of 4.38% during the forecast period from 2025 to 2032. The global ultrasound device market is growing due to rising demand for early and accurate diagnosis, increasing use in minimally invasive procedures, and advancements like 3D/4D imaging, AI, and portable systems. Its cost-effectiveness, safety, and wide applications in obstetrics, cardiology, and chronic disease management further boost adoption. Expanding healthcare access in emerging markets also supports growth.

Avisi Technologies to Present VisiPlate® 2-year Data at American Academy of Ophthalmology Annual Meeting

On 30 September 2026, Avisi Technologies announced that it had completed two-year follow-up of its VITA clinical trial evaluating the VisiPlate aqueous shunt in patients with primary open-angle glaucoma. The company planned to present the long-term clinical data at the 2026 American Academy of Ophthalmology Annual Meeting in New Orleans. 

The prospective, multicenter trial evaluated the safety and efficacy of the ultrathin, multichannel aqueous shunt, while additional presentations focused on its design, implantation approach, and clinical experience from the ongoing U.S. FDA investigational device exemption trial. The VisiPlate was designed to provide sustained aqueous drainage through multiple microchannels while addressing challenges associated with blockage, fibrosis, and the need for repeat intervention. The development supported continued innovation in surgical treatment options for glaucoma and highlighted ongoing clinical advancement of aqueous shunt technologies.

As per DelveInsight’s “Glaucoma Drainage Devices Market Report,” the global glaucoma drainage devices market was valued at USD 640.57 million in 2023, growing at a CAGR of 11.95% during the forecast period from 2024 to 2030, to reach USD 1,184.39 million by 2030. The increase in demand for Glaucoma Drainage Devices is primarily due to the rising prevalence of glaucoma across the globe, increasing lifestyle disorders such as diabetes & hypertension, the growing burden of the old age population, and technical innovation in product development are expected to boost the market for Glaucoma Drainage Devices.

FIRE1 Announced First Patient Implant in the NORM-HF Pivotal Trial Evaluating a New Physiologic Approach to Heart Failure Management 

On 30 September 2026, FIRE1 announced the enrollment and first patient implant in the NORM-HF pivotal trial, an international, multicenter study evaluating a physiologically guided approach to heart failure management. The trial was designed to assess whether daily monitoring of inferior vena cava physiology using the investigational NORM System, combined with physician-directed patient self-management, could reduce worsening heart failure events and cardiovascular mortality. 

The NORM System incorporated an implanted sensor, a wearable belt, and a connected patient application that generated patient-specific congestion assessments from daily readings. The trial planned to enroll approximately 800 patients with NYHA Class II or III heart failure who were at increased risk of decompensation. The study represented continued development of implantable physiologic monitoring technologies aimed at detecting congestion earlier and supporting proactive management of heart failure outside the hospital setting. The NORM System remained investigational and was not approved for commercial use in any geography.

“NORM-HF is not simply evaluating a new sensor–it is evaluating a potentially transformative model of heart failure care that will enable the patient to be actively engaged in their disease management,” said Conor Hanley, Chief Executive Officer of FIRE1. “Our goal is to determine whether physiologically guided, physician-directed self-management can help patients and clinicians identify congestion earlier, act sooner, and support a more scalable approach to heart failure care.”

According to DelveInsight’s “Hemodynamic Monitoring Systems Market Report,” The Global Hemodynamic Monitoring Systems market was valued at USD 982 million in 2023, growing at a CAGR of 6.29% during the forecast period from 2025 to 2032, in order to reach USD 1,416 million by 2032. The Hemodynamic Monitoring Systems market is witnessing positive market growth owing to factors such as the rising prevalence of cardiovascular diseases and diabetes, technological advancement in product development, an increasing geriatric population, sedentary lifestyles, and increasing awareness programs regarding cardiovascular diseases.