Nobles Medical Gains FDA Approval to Restart NobleStitch Clinical Trial

Nobles Medical Technology 2, a provider of cardiovascular closure solutions, announced it received FDA approval to resume its NobleStitch EL clinical trial for patent foramen ovale (PFO) closure. The minimally invasive device uses a suture-only method to close the small opening between the heart’s upper chambers, offering a potential alternative to metal implants. The company paused enrollment earlier this year following requests for additional safety and performance data, which it says have now been addressed.

Posted by MedCloudInsider Editors on 10/07/20250 comments

ZEISS Expands DORC Portfolio, Boosts Digital Surgery Workflow Integration

ZEISS, one of the leading medical technology companies listed on the MDAX and TecDAX of the German stock exchange, expanded its ophthalmic portfolio with new surgical instruments and digital workflow capabilities aimed at improving efficiency and visualization in vitreoretinal surgery. The updates enhance integration between DORC devices and ZEISS’s digital surgery platforms, allowing real-time data capture and imaging within a connected ecosystem. The company said the expansion supports improved surgical precision and workflow standardization across operating rooms.

Posted by MedCloudInsider Editors on 10/07/20250 comments

Xenocor Secures U.S. Patent for Single-Use Medical Borescope Technology

Xenocor, a Utah-based medical device company dedicated to transforming surgical visualization, announced it has received a U.S. patent for its next-generation single-use medical borescope technology, designed to improve visualization during minimally invasive procedures. The patented system integrates a lightweight optical sensor and advanced image-processing algorithms, enabling high-resolution imaging without the need for reusable or sterilized components. The company stated that the design reduces the risk of infection and lowers maintenance costs for hospitals and surgical centers.

Posted by MedCloudInsider Editors on 10/07/20250 comments

WaveBreak Reports Promising Data for Parkinson’s and Lewy Body Dementia

WaveBreak Therapeutics, a biopharmaceutical company developing a new class of therapeutics for the treatment of neurodegenerative diseases, has published new data demonstrating that its experimental compound, WTX-607, binds to and reduces alpha-synuclein aggregates in human brain tissue. The findings, shared at the International Congress of Parkinson's Disease and Movement Disorders, suggest that WTX-607 could slow or prevent neurodegeneration associated with Parkinson’s disease and Lewy body dementia. The company stated that the molecule penetrates brain tissue efficiently and has demonstrated efficacy in multiple preclinical models.

Posted by MedCloudInsider Editors on 10/07/20250 comments

OutcomeMD Launches Data Intelligence Network Built on Patient-Reported Outcomes

OutcomeMD has introduced the Patient Experience Data Network, the first data intelligence network powered by patient-reported outcomes (PROs). The platform aggregates de-identified data from healthcare organizations using OutcomeMD’s digital tools to measure how patients feel and function after treatment. Participating sites can benchmark outcomes, compare therapies, and access dashboards that link clinical claims and PRO data for research or value-based care initiatives. The launch aims to collect high-quality data to extract actionable insights that enable innovation and improvements in healthcare.

Posted by MedCloudInsider Editors on 10/07/20250 comments

Benchling Introduces AI Platform to Accelerate Scientific Research

Benchling, provider of a cloud-based platform for biotechnology research and development, has launched Benchling AI, a suite of generative and predictive tools built to streamline scientific workflows across drug discovery, biomanufacturing, and genomics. The platform integrates directly with Benchling’s cloud-based data system, enabling researchers to query experiments in natural language, generate molecular annotations, and surface insights from structured and unstructured datasets. Benchling CEO Sajith Wickramasekara stated, "The goal is to put AI in the hands of every scientist and bend the speed and cost curve of making medicines." Benchling AI features agents, including the Deep Research Agent, Data Entry Agent, and Compose Agent, enabling scientists to access models in one place for optimized experiments. 

Posted by MedCloudInsider Editors on 10/07/20250 comments

Medtronic Wins FDA Approval for Altaviva Urinary Incontinence Device

Medtronic announced FDA approval of the Altaviva device, designed to treat urge urinary incontinence (UUI). The device is a minimally invasive, implantable tibial neuromodulation (ITNM) therapy inserted near the ankle. Altaviva is intended for patients who do not feel comfortable with invasive therapies, given the potential side effects.  

The device is designed to have a 15-year battery lifespan, requiring no daily adjustments. It is MRI compatible and requires only 30 minutes of recharging. Medtronic, which has been investing heavily in connected care, is positioning Altaviva as part of its broader strategy to expand patient access and simplify treatment.  

Posted by MedCloudInsider Editors on 09/26/20250 comments

Marines Extend Use of Tagup AI for Battlefield Medical Logistics

The US Marine Corps has renewed its contract with defense tech company Tagup to continue using its AI-powered logistics platform, Manifest, for battlefield medical support. Manifest replaces legacy systems that often led to expired supplies, overstocked warehouses, or delayed missions. The AI tool is designed to optimize inventory management and accelerate the delivery of critical medical equipment to deployed forces. 
 
The renewal comes as the US Marine Corps aims to adopt a modernized approach to logistics, utilizing AI to ensure speed and precision. By keeping Tagup in its toolkit, the Marine Corps signals confidence in smaller defense tech firms to deliver agile solutions alongside larger contractors. It also ensures that Marines can receive the necessary medical supplies, regardless of the condition.

Posted by MedCloudInsider Editors on 09/26/20250 comments

New Health Standard for Predictive AI Ensuring Effective Tools from CTA

The Consumer Technology Association (CTA) has announced a new Health AI standard, CTA2135: Performance Verification and Validation for Predictive Health AI Solutions. This standard is designed to ensure predictive AI tools in healthcare are accurate, reliable, and ready for deployment. The announcement was made at the CTA’s Health AI+ event at Hopkins Bloomberg Center. 

CTA President Kinsey Fabrizio emphasized how the new standard is aimed at helping developers to fulfill AI’s promise of solving significant challenges that address patient and provider needs. 

Posted by MedCloudInsider Editors on 09/21/20250 comments

Olympus Rolls Out New Imaging Platform for ENT and Urology in the US

Olympus has launched the VISERAS OTV-S500, its newest imaging platform, designed for ear, nose, and throat (ENT) and urological procedures. The system is designed for both office and outpatient settings, offering flexible and rigid endoscope compatibility, along with a built-in lighting system that supports switching between white light, stroboscopy mode, and Narrow Band Imaging (NBI). 

A key feature of the VISERA S system is its tight integration with Olympus’s content management tools, including the nCare medical recorder and VaultStream system, enabling clinicians to capture procedural recordings and share data across sites within a facility. Olympus also emphasized that NBI technology has been shown to reduce recurrence in non-muscle invasive bladder cancer (NMIBC) by about 37% over a follow-up period of 1,235 months compared with white light cystoscopy alone. The VISERA S Video is not suitable for cardiac applications, but its main features include improved color, depth, and resolution for a clear view of vascular structures. 

Posted by MedCloudInsider Editors on 09/21/20250 comments

Eleos Unveils AI-Powered Solution for Group SUD Therapy Sessions

Eleos Health has launched Groups, a feature in its documentation platform aimed at simplifying individual speaker notes from group substance use disorder (SUD) therapy sessions. The new tool automatically produces individual speaker summaries from group sessions, whether in-person or via telehealth, while ensuring privacy standards are met to help organizations maintain compliance and reduce administrative overhead. 

The Groups capability works with any EHR system and integrates with Eleos’s existing documentation tools. Audio is processed in real time in a HIPAA-compliant environment; Eleos does not save raw session audio, protecting patient privacy. According to Eleos, the solution helps clinicians generate more than 80% of progress note content, with over 90% of notes submitted within 24 hours, and reduces documentation time by over 70%. 

Posted by MedCloudInsider Editors on 09/21/20250 comments

First Ever Awake Sedation Implant Done by Intrinsic Therapeutics with the Barricaid Annular Closure Device

Intrinsic Therapeutics, a medical technology company, has successfully implanted its Barricaid Annular Closure Device in several patients while they remained awake, marking the first time this procedure has been done without general anesthesia. Dr. Ernest E. Braxton Jr., a neurosurgeon specializing in awake and minimally invasive spine surgery, performed the operations in Vail, Colorado. 

The new approach uses local and regional anesthesia, enabling patients to provide real-time feedback during the procedure to confirm that nerve pressure has been relieved. Dr. Braxton has been performing awake surgery for more than a decade. Some benefits include a faster recovery period, reduced pain, and fewer risks commonly associated with general anesthesia, such as nausea or postoperative confusion. 

Posted by MedCloudInsider Editors on 09/21/20250 comments