STARMED Secures FDA 510(k) Clearance for Benign Thyroid Nodule Ablation; SciBase Advances U.S. Expansion with FDA 510(k) Submission for Nevisense; ALR Technologies to Acquire CGM Medical Technology in US$45 Million and 200 Million Share Deal; Co-Diagnostics Completes Validation Studies Ahead of FDA 510(k) Submission for Upper Respiratory Point-of-Care Test; Corvention Launches Innovative Balloon Catheter in the U.S. Following First Clinical Case; OrthAlign Reports First Clinical Cases Using Lantern® ASC System

STARMED Received FDA 510(k) Clearance for a Benign Thyroid Nodule Ablation Indication

On 01 July 2026, STARMED America announced that it had received FDA 510(k) clearance for the first radiofrequency ablation (RFA) system in the United States specifically indicated for the treatment of benign thyroid nodules. The clearance made STARMED the first and, at the time, the only company in the U.S. to receive an FDA indication for thyroid nodule RFA, representing a major milestone in the adoption of minimally invasive thyroid treatments.

The FDA-cleared indication covered the company’s VIVA combo RF Generator, STARMED RF Electrodes, and VIVA RF Electrodes for ultrasound-guided percutaneous ablation of cytologically confirmed benign thyroid nodules in adults who were symptomatic, cosmetically concerned, or had autonomously functioning thyroid nodules with a volume of less than 10 mL. The clearance provided physicians with a minimally invasive outpatient alternative to thyroid surgery while preserving healthy thyroid tissue and reducing the need for surgical intervention.

Commenting on the achievement, Henry Shin, CEO of STARMED Co., Ltd., stated, “From the first thyroid RFA procedure ever performed to the first FDA indication in U.S. history, STARMED has been the equipment behind the science. This clearance reflects the trust physicians and researchers around the world have placed in our technology for more than two decades.”

The company noted that the FDA clearance was supported by more than 300 clinical publications generated using STARMED equipment and marked the culmination of over two decades of clinical innovation in thyroid radiofrequency ablation. The approval was also expected to simplify hospital adoption, align with established reimbursement pathways, and accelerate the availability of minimally invasive thyroid nodule treatment across the United States.

As per DelveInsight’s “Radiofrequency Ablation Devices Market Report,” the global radiofrequency ablation devices Market is expected to increase from USD 3,934.08 million in 2024 to USD 9,125.13 million by 2032, growing at a CAGR of 11.16% during the forecast period from 2025 to 2032. The Radiofrequency Ablation Devices Market solution is being primarily driven by the rising prevalence of cardiovascular diseases and rising prevalence of cancers globally.

SciBase Submitted FDA 510(k) to Expand Nevisense into the Largest Skin Cancer Market 

On 01 July 2026, SciBase announced that it had submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking to expand the indication for its Nevisense® platform. The submission aimed to include skin lesions with characteristics of keratinocyte skin cancer, allowing the company to enter the largest skin cancer diagnostic market in the United States. If cleared, the expanded indication was expected to substantially increase the clinical applications of Nevisense and strengthen its position in dermatology diagnostics.

The expanded indication was intended to enable Nevisense to assist clinicians in evaluating both melanoma and keratinocyte skin cancers using the same non-invasive, AI-supported electrical impedance spectroscopy (EIS) technology. Keratinocyte skin cancer, which includes basal cell carcinoma and squamous cell carcinoma, represents the most common form of skin cancer, making the proposed indication a significant commercial opportunity for the company.

Commenting on the submission, Pia Renaudin, Chief Executive Officer of SciBase, stated, “This submission is an important milestone in our strategy to expand Nevisense into the largest skin cancer market. With this expanded indication, we expect to significantly increase the addressable market for Nevisense and provide dermatologists with an even more valuable decision-support tool for the assessment of suspicious skin lesions.”

The company noted that the submission was supported by clinical evidence demonstrating the capability of Nevisense to identify lesions associated with keratinocyte skin cancer. If the FDA granted clearance, the expanded indication was expected to improve diagnostic decision-making, support earlier detection of skin cancer, and broaden the adoption of Nevisense across dermatology practices in the United States.

As per DelveInsight’s “Dermatology Devices Market Report,” The global dermatology devices market was valued at USD 6.27 billion in 2023, growing at a CAGR of 12.47% during the forecast period from 2024 to 2030 to reach USD 12.69 billion by 2030. The Dermatology Devices market is slated to witness prosperity owing to factors such as the growing prevalence of chronic skin problems such as acne, atopic dermatitis, and psoriasis among others, further increasing awareness of skin care and the growing focus on improving the safety and usability of dermatology devices for end-users are further expected to result in the appreciable revenue growth in the dermatology devices market during the forecast period (2024-2030).

On 30 June 2026, ALR Technologies SG Ltd. announced that it had entered into a Letter of Intent (LOI) to acquire 100% of the equity of CGM Medical Technology Singapore Pte. Ltd. and the assets of CGM Medical Technology Shenzhen Ltd. for a total consideration of 200 million ordinary shares and up to US$45 million, subject to the fulfillment of specified conditions. The proposed acquisition was intended to strengthen the company’s position in the continuous glucose monitoring (CGM) industry by integrating manufacturing capabilities, intellectual property, and product development expertise.

Under the terms of the LOI, ALR Technologies agreed to acquire CGM Medical Singapore for 200 million ordinary shares along with an aggregate of US$40 million through an unsecured, non-interest-bearing promissory note structured as an earn-out. The company also agreed to acquire the assets of CGM Medical Shenzhen for up to US$5 million, with an initial payment at closing and the remaining balance scheduled through a percentage of future free cash flow. The transaction was expected to support the establishment of a large-scale automated manufacturing facility in the Johor–Singapore Special Economic Zone (JS-SEZ) while significantly expanding CGM production capacity.

Commenting on the acquisition, Sidney Chan, Chairman and CEO of ALR Technologies, stated, “The acquisition of CGM Medical will make ALRT a fully integrated diabetes company from start to finish. We will own the intellectual property and technology to produce the continuous glucose monitors (“CGM”) used in the GluCurve Pet CGM and the future human health CGM we will be launching. The acquisition will enable us to increase margins and have full control of our products and services. The expertise of CGM Medical will also contribute to the design, development, and commercialization of other medical devices for diabetes management and additional chronic diseases.”

The company also initiated the purchase of additional automation equipment valued at approximately US$1.65 million for the Shenzhen manufacturing operation to increase production capacity to 300,000 CGMs per month. The expanded manufacturing capability was expected to support the commercialization of the GluCurve Pet CGM and future human CGM products while enhancing ALR Technologies’ long-term growth strategy in the diabetes management sector. The proposed acquisitions remained subject to definitive agreements, due diligence, regulatory approvals, and other customary closing conditions.

As per DelveInsight’s “Blood Glucose Monitoring System Market Report,” The blood glucose monitoring systems market was valued at USD 12.12 billion in 2024 and expected to reach USD 18.89 billion by 2032. The Blood Glucose Monitoring Systems Market is expected to grow at a CAGR of 7.72% during the forecast period from 2025 to 2032. The blood glucose monitoring systems market is expanding rapidly due to the rising prevalence of lifestyle style disorders such as diabetes and impaired glucose tolerance, growing product launches and approvals by key players, and a rising preference for minimally invasive techniques that are expected to significantly drive the demand for blood glucose monitoring systems from 2025 to 2032.

Co-Diagnostics Completed Clinical and Analytical Studies in Preparation for FDA 510(k) Submission of Upper Respiratory Point-of-Care Test 

On 01 July 2026, Co-Diagnostics announced that it had completed the clinical and analytical performance studies for its Co-Dx™ PCR Flu A/B & RSV upper respiratory multiplex test designed for use with the Co-Dx PCR Pro® instrument. The completed studies marked a significant milestone in the company’s preparation for a Dual FDA 510(k) and CLIA Waiver by Application submission, which was targeted for the third quarter of 2026. The clinical program enrolled more than 1,400 symptomatic patients across nine geographically diverse clinical sites in the United States, while the analytical evaluation included 27 individual studies and more than 10,000 PCR test cup runs.

The analytical validation also included studies supporting the CLIA Waiver by Application, allowing the test to be used in waived point-of-care settings. In addition, the company completed a multicenter reproducibility study that demonstrated consistent test performance across different operators, instruments, and testing sites, including use by untrained personnel. These results were expected to form part of the planned FDA submission package.

Commenting on the achievement, Dwight Egan, Chief Executive Officer of Co-Diagnostics, stated, “Completing both the analytical and clinical performance studies for the upper respiratory test is a significant execution milestone for Co-Diagnostics. The FDA 510(k) and CLIA Waiver by Application processes require substantial analytical and clinical evidence, and the depth of the work our team has completed, including 27 individual analytical studies, over 10,000 PCR test cup runs, and a clinical study enrolling more than 1,400 symptomatic patients across 9 geographically distinct US clinical sites, reflects the quality of the submission we are preparing to make. We are targeting submission in Q3 2026 and remain confident in our path to clearance.”

He further added, “The reproducibility study was designed to evaluate whether performance observed in clinical settings could be replicated across different operators, sites and instruments, and the results support inclusion of those data in our planned FDA submission. That consistency is central to what a CLIA Waiver requires and to our broader vision of bringing accurate, near-patient PCR diagnostics to decentralized settings. This platform was designed to perform at that standard.”

According to DelveInsight’s “Point of Care Diagnostic Market Report,” the global point of care diagnostics market is estimated to grow at a CAGR of 6.61% during the forecast period from 2025 to 2032. The demand for point of care diagnostics is primarily being boosted by the increasing patient population suffering from various lifestyle disorders such as diabetes and cardiovascular diseases among others, the rising prevalence of infectious diseases, growing awareness regarding health and disease-free life, and innovation in product development among others, thereby contributing to the overall growth of the point of care diagnostics market during the forecast period from 2025-2032.

Corvention Announces First Case in the U.S. and Initiates Limited Commercial Launch of Innovative Balloon Catheter 

On 24 June 2026, Corvention announced the successful completion of the first U.S. procedure using its proprietary KardiaPSI™ balloon catheter. The milestone case was performed by interventional cardiologist Dr. Alan Zajarias in St. Louis, Missouri, marking an important advancement for the company’s structural heart technology platform.

The procedure officially initiated the limited commercial launch of the KardiaPSI balloon catheter in the United States following its recent FDA 510(k) clearance for balloon valvuloplasty. Designed to provide enhanced procedural control and consistent performance during valvuloplasty interventions, the catheter demonstrated its clinical utility in the inaugural case. Through the limited launch program, Corvention planned to work closely with selected healthcare institutions to support clinical adoption, optimize procedural outcomes, and gather real-world experience with the technology.

“We are thrilled to achieve this pivotal milestone alongside Dr. Zajarias and his exceptional team in St. Louis” said Michael Franklin, CEO of Corvention. “The successful clinical debut of the KardiaPSI balloon catheter underscores our commitment to providing interventionalists with advanced, high-performance tools designed to optimize outcomes in structural heart procedures. This first case lays the foundation for our controlled rollout across elite cardiovascular centers nationwide.”

According to DelveInsight’s ”Transcatheter Heart Valve Replacement Devices Market Report,” The Transcatheter Heart Valve Replacement Devices Market is estimated to grow at a CAGR of 13.75% during the forecast period from 2024 to 2030. The Transcatheter Heart Valve Replacement 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, and increasing preference for minimally invasive surgeries that are expected to escalate the overall growth of the transcatheter heart valve replacement market during the forecast period from 2024 to 2030.

OrthAlign Announced First Cases with Lantern® ASC System, Eliminating the Economic Barriers of Robotic Technology

On 01 July 2026, OrthAlign announced the successful completion of the first clinical cases using its Lantern® ASC system, a handheld surgical navigation platform developed specifically for ambulatory surgery centers (ASCs). The initial procedures were performed by orthopedic surgeon and ASC owner Dr. Zane Uhland, who completed six total knee replacement surgeries in a high-efficiency outpatient setting in less than four hours. The achievement demonstrated the system’s capability to provide advanced surgical navigation while addressing the financial and operational limitations associated with traditional robotic technologies.

Unlike conventional robotic platforms that require substantial capital investment, annual service contracts, dedicated operating room space, and implant volume commitments, the Lantern® ASC system offered a portable, scalable, and cost-effective alternative. The system combined a reusable navigation unit with a procedural Smart Pack Kit, enabling real-time navigation for total knee, partial knee, and ligament balancing procedures in both primary and revision surgeries while remaining compatible with most major implant systems.

Commenting on the first clinical experience, Dr. Zane Uhland stated, “As both a surgeon and an ASC owner, I’ve always believed that technology should enhance patient care without creating additional complexity for the surgical team or the facility. Lantern ASC delivered exactly that. The system integrated seamlessly into our workflow, provided the real-time data needed to confidently make intraoperative decisions, and allowed us to maintain an efficient surgical schedule without sacrificing precision. In the ASC environment, where efficiency matters, it’s rare to find technology that improves decision-making while fitting so naturally into the way we already operate.”

The company stated that the Lantern® ASC system enabled healthcare facilities to adopt advanced navigation technology without compromising financial flexibility. It was designed to integrate smoothly into existing clinical workflows, allowing surgeons to select the implant system that best suited each patient while helping ASCs improve efficiency, scalability, and procedural accuracy.

According to DelveInsight’s “Surgical Navigation Systems Market Report,” the global surgical navigation systems market was valued at USD 7,753.34 million in 2023, growing at a CAGR of 6.76% during the forecast period from 2024 to 2030. The demand for surgical navigation systems is primarily being boosted by the increasing prevalence of various chronic diseases such as stroke, Alzheimer’s, cerebrovascular disease, and others. Further, the rising incidences of orthopedic disorders, especially among the geriatric population, along with increasing demand for minimally invasive surgical procedures, and growing activities for research and development for surgical navigation systems, are thereby contributing to the overall growth of the surgical navigation systems market during the forecast period from 2024 to 2030.