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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.

NeuroOne Medical Technologies Corporation Reduces Debt by $3.3 Million and Strengthens Balance Sheet

NeuroOne Medical Technologies Corporation, a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announces that during July 2020, the Company retired approximately $3.3 million of debt, strengthening the Company’s balance sheet. NeuroOne is now transitioning to advancing commercialization planning, building its financial infrastructure, and additional product development.

“Now that we have shored up our balance sheet, we are well-positioned to prepare for commercialization of our EVO Cortical Electrode product line with Zimmer Biomet, our strategic commercialization partner, accelerate additional research and development efforts, and explore uplisting to a national securities exchange,” says Dave Rosa, president and CEO, NeuroOne.

The result of a collaboration with the University of Madison-Wisconsin’s Alumni Research Foundation and the Mayo Foundation for Medical Education and Research, EVO is designed for the diagnosis and treatment of various neurological conditions, including epilepsy. EVO is based on thin-film, high-definition electrodes designed to record and monitor brain activity and stimulate brain tissue for up to 30 days. Additional potential future applications include: Parkinson’s disease (PD), brain tissue ablation and chronic pain due to failed back surgeries.

EVO received FDA 510(k) clearance in December 2019. By the end of 2020, NeuroOne plans to complete a 510(k) submission to the FDA of its stereoelectroencephalography (sEEG) Depth Electrode.

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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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New England Biolabs® Introduces NEBNext® Custom RNA Depletion Design Tool and RNA Depletion Core Reagent Set for Customizable RNA Depletion

This technology has been superb for eliminating the ribosomal RNA for a range of custom projects, including tracking novel viruses in mosquitoes, longitudinal profiling for astronauts, and host-pathogen interactions in COVID samples.

INTERCEPT Blood System for Cryoprecipitation Receives FDA Approval States Cerus Corporation

"FDA approval of the INTERCEPT Blood System for Cryoprecipitation is an important step forward in our mission to establish pathogen reduction as the standard of care for transfused blood components globally," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer.

Research Paper Showing ProtoKinetix AAGP® Enhanced Stem Cell Derived Retina Precursor Cells Restoration of Vision

ProtoKinetix notes the research paper has been submitted to a prestigious journal specializing in tissue regeneration for peer review and editing.

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

OrganBio, a Miami-based cGMP facility, will include process development space, ISO 7 cleanrooms, state-of-the-art scientific equipment, analytics and QC laboratories, and a suite of support services to enable OrganaBio and its partners to rapidly and economically self-manufacture clinical materials. 

Stoke Therapeutics Announces Proposed Public Offering

November 18, 2020 Stoke Therapeutics, Inc., a biotechnology company pioneering a new way to treat the underlying cause of genetic diseases by precisely upregulating protein...