Geneseeq Technology Inc.’s GENESEEQPRIME® Assay Receives FDA 510(k) Clearance; Medtronic’s MiniMed™ 780G Gains FDA Approval for Abbott Instinct Sensor Integration and Type 2 Diabetes Use; CorNeat Vision’s Artificial Cornea Restores 20/20 Vision for Shingles-Induced Blindness; Johnson & Johnson Reports Favorable Outcomes from Real-World VARIPULSE™ PFA Study at 2025 ESC Congress; SprintRay Strengthens Dental 3D Printing Portfolio with EnvisionTEC Acquisition; Olympus Unveils Latest Imaging Platform for ENT and Urology in the U.S.

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Geneseeq Technology Inc.’s GENESEEQPRIME® Assay Receives FDA 510(k) Clearance; Medtronic’s MiniMed™ 780G Gains FDA Approval for Abbott Instinct Sensor Integration and Type 2 Diabetes Use; CorNeat Vision’s Artificial Cornea Restores 20/20 Vision for Shingles-Induced Blindness; Johnson & Johnson Reports Favorable Outcomes from Real-World VARIPULSE™ PFA Study at 2025 ESC Congress; SprintRay Strengthens Dental 3D Printing Portfolio with EnvisionTEC Acquisition; Olympus Unveils Latest Imaging Platform for ENT and Urology in the U.S.

Sep 04, 2025

Geneseeq Technology Inc. Received FDA 510(k) Clearance for GENESEEQPRIME® Assay

On September 02, 2025, Geneseeq Technology Inc. announced that the U.S. Food and Drug Administration (FDA) had granted 510(k) clearance for its GENESEEQPRIME® NGS Tumor Profiling Assay. This in vitro diagnostic (IVD) test kit used next-generation sequencing (NGS) to detect gene alterations in patients with solid malignant neoplasms.

The GENESEEQPRIME® assay was designed to interrogate 425 cancer-related genes and detect multiple types of genomic alterations, including single-nucleotide variants (SNVs), insertions/deletions (indels), and selected gene amplification and translocations. It also provided data on microsatellite instability (MSI) and tumor mutation burden (TMB).

The assay was delivered as a ready-to-use IVD kit, which allowed for decentralized implementation in oncology laboratories. This supported local adoption while maintaining globally consistent standards. The GENESEEQPRIME® assay was paired with GENESIS by GENESEEQ®, the company’s proprietary bioinformatics pipeline and reporting system. This entire solution provided laboratories with a streamlined workflow and a consistent framework for data analysis and reporting.

The FDA clearance was a significant step for Geneseeq, strengthening its ability to support multi-regional clinical trials, biomarker-driven drug development, and future companion diagnostic (CDx) strategies. The assay provided a standardized, validated platform that promoted data harmonization and operational efficiency across different geographic regions. This milestone followed prior regulatory achievements, including CE-IVD marking in Europe and NMPA approval in China, solidifying Geneseeq’s position as a global leader in precision oncology..

“FDA 510(k) clearance of GENESEEQPRIME® marks a major milestone for Geneseeq and for the broader oncology community,” said Xue Wu, PhD, CEO of Geneseeq Technology Inc. “By enabling laboratories to deliver high-quality genomic profiling locally on a standardized, regulatory-cleared platform, we are expanding patient access to precision medicine and supporting innovation in cancer care worldwide.”

As per DelveInsight’s “In Vitro Diagnostics Market Report”, the global in vitro diagnostics market was valued at USD 71.01 billion in 2024, growing at a CAGR of 4.71% during the forecast period from 2025 to 2032, to reach USD 93.60 billion by 2032. The in vitro diagnostics market is expected to experience positive revenue growth due to several factors, including the rising prevalence of infectious diseases like COVID-19, the growing incidence of various cancers, an increase in hematological diseases, and a surge in product development activities for in vitro diagnostics, among other factors.

Medtronic’s MiniMed™ 780G System Received FDA Clearance for Integration with Abbott’s Instinct Sensor and for Use in Type 2 Diabetes

On September 02, 2025, Medtronic plc., a leader in healthcare technology, recently announced two major regulatory milestones from the U.S. Food and Drug Administration (FDA) that broadened its MiniMed™ 780G system portfolio. The company secured clearance for its SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC), which enabled its integration with the Instinct sensor from Abbott for people with type 1 diabetes. Additionally, the FDA approved the MiniMed™ 780G system for use in adults aged 18 and older with insulin-requiring type 2 diabetes.

This clearance, paired with the earlier clearance of the MiniMed™ 780G insulin pump as an alternate controller enabled (ACE) pump, finalized the FDA pre-market approval process for integrating the Instinct sensor into the MiniMed™ 780G system for individuals with type 1 diabetes. The Instinct sensor, which Abbott exclusively designed for Medtronic’s automated insulin delivery devices (AID) systems, was considered the world’s smallest and thinnest integrated continuous glucose monitor (iCGM) and featured a wear time of up to 15 days.

Medtronic and Abbott planned to complete their necessary compliance documentation in the following weeks, which would enable the marketing and integration of the sensor. Once this step was finalized, the companies would begin taking orders for the Instinct sensor with the MiniMed™ 780G system. The existing customers were expected to have priority access through the Innovations Program, and pre-orders for the Simplera Sync™ sensor were also slated to begin later in the month.

“These milestones mark an important next step in our work to bring the proven performance and outcomes of our MiniMed™ 780G automated insulin delivery system to more people living with diabetes. By enabling integration with the Instinct sensor and expanding the MiniMed™ 780G system to people with type 2 diabetes, we are advancing a smart dosing ecosystem designed to provide greater choice and flexibility, along with a more seamless experience,” said Que Dallara, Executive Vice President and President of Medtronic Diabetes and CEO Designate of MiniMed. “We’re excited to expand our ecosystem of solutions under one roof with a service our customers can count on around the clock.”

As per DelveInsight’s “Insulin Infusion Pumps Market Report”, the global insulin infusion pumps market was valued at USD 6.48 billion in 2023, growing at a CAGR of 8.69% during the forecast period from 2024 to 2030 to reach USD 10.68 billion by 2030. The insulin infusion pumps market is slated to witness prosperity owing to factors such as growing prevalence of diabetes, increasing sedentary lifestyle, growing aging population base which is susceptible to the development of diabetes, and the growing focus on improving the safety and usability of insulin infusion pumps are further expected to result in the appreciable revenue growth in the insulin infusion pumps market during the forecast period from 2024 to 2030.

CorNeat Vision’s Artificial Cornea Restored Perfect 20/20 Vision in Shingles-Blinded Eye 

On September 02, 2025, CorNeat Vision, an innovative ophthalmic device company, recently announced a significant clinical achievement: the restoration of perfect vision in a patient who had been blinded by corneal scarring from Shingles. After receiving the company’s artificial cornea, the CorNeat KPro, the patient’s vision was fully restored to 6/6 (20/20) and remained stable 11 months after the operation.

In addition to the remarkable functional recovery, the procedure delivered an impressive aesthetic transformation. The patient’s eye, which had been visibly damaged by Shingles, looked natural and healthy. What made this achievement even more significant was that the patient was never considered a candidate for traditional corneal transplantation. The CorNeat KPro’s design, which uniquely integrated with the eye wall beneath the conjunctiva, allowed for a stable and long-term implantation without the need for donor tissue.

“Restoring 20/20 vision to a blind eye with the CorNeat KPro is a powerful testament to how innovation and vision come together to change lives. At Beilinson’s Ophthalmology Department, we are committed to leading with cutting-edge technologies, and this breakthrough reflects our mission to bring the future of eye care into the present,” said Prof. Irit Bahar, Head of Ophthalmology, Beilinson Hospital.

“This is a landmark achievement,” said Dr. Gilad Litvin, CorNeat Vision’s Co-Founder and Chief Medical Officer. “Delivering sight and aesthetics to an eye once beyond help highlights the sheer impact of our artificial cornea. This breakthrough not only restores vision for patients with untreatable corneal conditions but also delivers hope to millions of blind patients living in regions where donor tissue is scarce.”

As per DelveInsight’s “Artificial Cornea and Corneal Implant Market Report”, the artificial cornea and corneal implant market is on a trajectory of significant growth, with projections showing its value expanding from USD 378.61 million in 2023 to an estimated USD 659.19 million by 2030. This represents a CAGR of 8.0% from 2024 to 2030. The market for artificial corneas and corneal implants is experiencing significant expansion due to several key factors. A primary driver is the growing willingness of consumers to invest in advanced eye care treatments. Additionally, the increasing prevalence of ophthalmic diseases, such as keratoconus, Fuchs dystrophy, and infectious keratitis, is propelling market growth by creating a higher demand for solutions. This trend is further supported by rising healthcare expenditures on eye care, especially in developing countries. Finally, a greater number of surgical procedures and the demand for innovative treatment techniques are creating substantial opportunities for the market’s continued growth.

On September 02, 2025, at the 2025 European Society of Cardiology (ESC) Congress in Madrid, Johnson & Johnson MedTech, a leader in treating cardiac arrhythmia, shared the acute safety and effectiveness results from the VARIPURE substudy of SECURE. The study evaluated the VARIPULSE™ Platform in pulsed field ablation devices (PFA) procedures for atrial fibrillation (AF). The real-world data, collected from 791 patients, demonstrated a strong safety profile, high acute effectiveness, and procedural efficiency. Notably, the study reported a 0.6% primary adverse rate, with no strokes, and a 99.7% acute PVI.

VARIPURE was a prospective, observational, post-market study conducted at 20 centers across Europe, involving 62 operators. The study evaluated the acute safety, effectiveness, and procedural characteristics of index AF ablations performed with the VARIPULSE™ Platform. The platform itself consists of the VARIPULSE™ Catheter and the TRUPULSE™ Generator, which work with the CARTO™ 3 System to provide an efficient and reproducible workflow. This seamless integration enhanced treatment and optimized outcomes for AF patients.

According to DelveInsight’s “Cardiac Ablation Devices Market Report”, the cardiac ablation devices market was valued at USD 2.25 billion in 2023, growing at a CAGR of 12.77% during the forecast period from 2024 to 2030, to reach USD 4.63 billion by 2030. The demand for cardiac ablation devices is motivated by a rise in the prevalence of cardiovascular diseases like cardiac arrhythmia, atrial fibrillation, and stroke. Additionally, minimally invasive procedures like cardiac ablation are gaining traction due to their advantages over traditional open-heart surgeries. Patients prefer these procedures because they offer shorter recovery times, reduced hospital stays, and lower risks of complications such as infection and bleeding. Furthermore, the growing awareness about cardiac arrhythmias and advancements in diagnostic technologies have led to earlier detection through screening programs. As awareness increases among patients and healthcare providers alike, there is a corresponding rise in the number of cases diagnosed and treated. This trend not only expands the market for cardiac ablation devices but also supports timely intervention and better management of cardiac conditions, improving overall patient outcomes during the forecast period from 2024 to 2030.

SprintRay Acquired EnvisionTEC Dental Product Portfolio, Expanding Commitment to 3D Printing in Dentistry 

On September 02, 2025, SprintRay, a leading company in dental 3D printing, announced its acquisition of the dental product portfolio from EnvisionTEC/ETEC (formerly part of Desktop Health). This strategic purchase included the company’s patents, trademarks, inventory, and other intellectual property related to its dental materials and 3D bioprinting technologies. This move demonstrated SprintRay’s focus on dentistry and its commitment to offering dental professionals reliable hardware and regulatory-compliant resins.

With the acquisition of EnvisionTEC, SprintRay gained a portfolio of technologies from one of the early players in dental 3D printing. Over more than 20 years, EnvisionTEC has developed over 200 patents covering 3D printing hardware and materials and has established a strong customer base in dental labs and practices globally. Its portfolio included platforms like the Envision One with patented cDLM (continuous digital light manufacturing) technology. Under the Desktop Health brand, the company had expanded into the Einstein DLP printer line and offered materials such as Flexcera, a hybrid nanoceramic resin for 3D printing dental prosthetics, which had already received FDA 510(k) Class II clearance, CE Mark, and MDR Class I certification. Through this transaction, SprintRay integrated a significant amount of intellectual property, proven technologies, and an established customer base, which strengthened its offerings for both lab and chairside applications.

“SprintRay’s acquisition of EnvisionTEC’s dental portfolio ensures existing customers continue to have the tools and support they rely on, while also strengthening our position in dental labs,” said Amir Mansouri, PhD, SprintRay Co-founder and CEO. “Our mission to transform dentistry through accessible, reliable 3D printing technology hasn’t wavered. This strategic move reinforces that commitment.”

As per DelveInsight’s “Dental Equipment Market Report”, the dental equipment market was valued at USD 7,873.25 million in 2023, growing at a CAGR of 5.38% during the forecast period from 2024 to 2030 to reach USD 10,745.89 million by 2030. The increase in demand for dental equipment is primarily attributed to the growing prevalence of dental infections such as tooth abscess, gingivitis, tooth caries, and other periodontal diseases. Further, increasing demand for dental care facilities and dental surgical procedures, growing demand for cosmetic dentistry, technological advancements in dental laser and radiology, increasing geriatric population suffering from dental disorders, and introduction of multiple government initiatives for public oral health care across the world are anticipated to bolster the market, thereby contributing to the growth of the dental equipment market during the forecast period from 2024 to 2030.

Olympus Announced the U.S. Launch of Newest Imaging Platform for ENT and Urological Applications 

On September 02, 2025, Olympus Corporation, a global medical technology company, recently announced the U.S. launch of the VISERA™ S OTV-S500 imaging platform. The new platform was designed to integrate advanced diagnostic capabilities for ear, nose, and throat (ENT) and urology applications, offering a flexible solution for both office and outpatient settings.

The VISERA S video system featured a built-in light system that allowed clinicians to switch between white light, stroboscopy mode, and Narrow Band Imaging™ (NBI™) technology with a single touch. This capability provided enhanced visualization for the detection, characterization, and treatment of ENT diseases, such as vocal fold polyps and glottic cancer, as well as urological diseases like non-muscle invasive bladder cancer.

The platform was designed for easy transitions between imaging tools and was compatible with a wide range of endoscopes. Its compact design allowed it to integrate easily into existing office and outpatient settings.

In line with Olympus’ focus on diagnostic and patient-centered innovation, the VISERA S video system was designed to provide improved image quality compared to its predecessor, the CV-170. It also included a pre-freeze function for capturing clear images and the ability to record video.

Additionally, the VISERA S video system is integrated with Olympus’ nCare™ medical recorder and VaultStream™ medical content management system, which enables physicians to capture clear recordings and create a comprehensive procedural record. This record could then be accessed and shared across different sites within a medical facility.

“Whether in an office or outpatient setting, physicians are looking for opportunities to combine procedural and cost efficiencies, which is why we are excited to launch the VISERA S imaging platform for ENT and urological applications,” said Richard Reynolds, President of the Medical Systems Group at Olympus Corporation of the Americas. “The VISERA S video system may provide cost efficiencies by offering compatibility with a wide range of endoscopes and procedural and workflow efficiencies by combining multiple light systems in one platform and the ability to gather and share patient data from one system.”

As per DelveInsight’s “Diagnostic Imaging Equipment Market Report,” the diagnostic imaging equipment market was valued at USD 24.15 billion in 2020, growing at a CAGR of 5.10% during the forecast period from 2024 to 2030, to reach USD 33.56 billion. The demand for diagnostic imaging equipment is primarily driven by several factors, including rising technological advancements, the growing burden of chronic diseases, increasing patient awareness of the importance of early-stage diagnosis, the demand for effective & efficient imaging technologies, and the increasing geriatric population.

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