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Attune Medical Major Milestones: Including ensoETM in Cardiac Ablation Procedures Published Study and $4 Mil Convertible Note Closing

Dr. Mark Gallagher (St. George’s University Hospital, London UK) evaluated the use of the ensoETM in cardiac ablation procedures to ascertain whether using the esophageal space for temperature management could have the potential to decrease collateral thermal injury related to radio-frequency (RF) ablation for the treatment of atrial fibrillation.

Signia Introduces World’s First ‘Face Mask Mode’ for Hearing Devices: Improves Audibility for Those Communicating with Someone Wearing a Face Covering & No More Lip Reading

“The hearing challenges presented by face masks became obvious pretty quickly into the pandemic, so Signia developed the first-of-its-kind Face Mask Mode to help those with hearing loss better communicate in this new reality,” said Tish Ramirez, Au.D. of Signia. “When this setting is activated, the hearing aids optimally capture the sound of the speech signals, enabling the words to sound clearer and reducing any background noise to help the wearer understand what is being said.” 

Modulim Announces CE Mark of Clarifi Imaging System for Microvascular Assessment

Modulim can now expand its marketing and distribution throughout Europe and apply for registration in other international markets that recognize the CE Mark.

Genius AI Detection Receives FDA Clearance

Hologic notes the new technology which the company has now made commercially available represents a pivotal milestone in the early detection of breast cancer, as studies showed Genius AI Detection software aids in the identification and early detection of breast cancer when used with the Genius 3D Mammography exam.

Kubota Vision Demonstrates 3D Imaging Capabilities Using AI on PBOS

Kubota Vision, a clinical-stage ophthalmology company and wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Tokyo 4596), today announced that the company demonstrated 3D imaging capabilities using artificial intelligence (AI) on their Patient Based Ophthalmology Suite (PBOS), in-home optical coherence tomography (OCT) device.*1

Kubota Vision completed a successful clinical study in October 2018 that demonstrated the PBOS could detect thinning and thickening of the human retina over time, when compared to results from an established commercial OCT device. (See October 28, 2018 press release titled “Acucela Completes PBOS Clinical Study and Validates Concept.”)

A commercial OCT device is large and expensive, and mainly used at large eye clinics/centers and laboratories; however, our PBOS is a home-based, patient-friendly, ophthalmic self-monitoring miniature OCT device designed to detect disease progression. It uses network connectivity and cloud-based technologies to share images and alert patients and their physicians of disease progression and re-treatment needs, without requiring physician office visits.

The first fully-functional, working PBOS prototypes have been completed, and the company is currently in the process of further improving the software including 3D imaging capabilities. The 3D imaging assists in the detection of fluid buildup within and under the retina of the eye. Kubota Vision will continue advancing this program and seeking partnership opportunities for commercialization.

Ryo Kubota, MD, PhD, Chairman, President and CEO of Kubota Vision, stated, “We are excited to share this great news that our PBOS demonstrated 3D imaging capabilities using AI via internet data transfer. We will continue working on its improvement as well as gathering data to become a big data-driven company in ophthalmology. Our goal is to improve the quality of how we treat patients with ophthalmic diseases and make it available globally to people in need.”


*1 OCT (Optical Coherence Tomography) is a non-invasive tool that uses light waves to take cross-section pictures of the retina.

*2 mHealth refers to the usage of mobile communications technology and devices to enhance access to healthcare information, improve distribution of routine and emergency health services, and provide diagnostic services.

Latest Posts

Fusion Antibodies and Queen’s University Belfast Awarded a £453,000 Grant from Invest Northern Ireland

The two organisations will use the funds to accelerate the discovery of novel therapeutic and diagnostic antibodies with validated anti-infective properties against COVID-19. Building on strong scientific knowhow, a new antibody development platform will be created that will help realise the vision of producing a breakthrough therapeutic that directly targets SARS-CoV-2.

Attune Medical Major Milestones: Including ensoETM in Cardiac Ablation Procedures Published Study and $4 Mil Convertible Note Closing

Dr. Mark Gallagher (St. George’s University Hospital, London UK) evaluated the use of the ensoETM in cardiac ablation procedures to ascertain whether using the esophageal space for temperature management could have the potential to decrease collateral thermal injury related to radio-frequency (RF) ablation for the treatment of atrial fibrillation.

Signia Introduces World’s First ‘Face Mask Mode’ for Hearing Devices: Improves Audibility for Those Communicating with Someone Wearing a Face Covering & No More Lip Reading

“The hearing challenges presented by face masks became obvious pretty quickly into the pandemic, so Signia developed the first-of-its-kind Face Mask Mode to help those with hearing loss better communicate in this new reality,” said Tish Ramirez, Au.D. of Signia. “When this setting is activated, the hearing aids optimally capture the sound of the speech signals, enabling the words to sound clearer and reducing any background noise to help the wearer understand what is being said.” 

Kayentis, a global provider of digital data capture systems for clinical trials, today announces it has raised €7M (approx. $8.3M) in growth capital.

Kayentis is active in the global electronic Clinical Outcome Assessment (eCOA) market, which is expected to reach $2.6 billion by 2027. Market growth in eCOA – a method of capturing outcomes data electronically in clinical trials – is driven by the clinical trials industry.

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OrganaBio to Expand Its cGMP Cell and Gene Therapy Manufacturing Facility: 19,000 Sq. Ft. Slated to Commence Operations In Q3 2021

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Stoke Therapeutics Announces Proposed Public Offering

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