More News of Interest

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.

PhotoniCare Announces FDA Clearance for First-In-Class Technology for Imaging the Ear

January 6, 2020

PhotoniCare, Inc., a company dedicated to revolutionizing healthcare by providing healthcare providers with better diagnostic tools, today announced that the U.S. Food & Drug Administration (FDA) has granted 510(k) clearance for its TOMi™ Scope for non-invasive imaging of the middle ear.

PhotoniCare notes using optical coherence tomography (OCT) high resolution depth imaging, TOMi Scope helps to determine the presence or absence of fluid in the middle ear and to characterize the fluid type.

“Current tools can only provide a view of the surface of the eardrum, forcing healthcare providers to make an assessment with very limited information, or to employ invasive surgical procedures to accurately identify middle ear pathologies,” said Diego Preciado, M.D., Ph.D. of the Children’s National Hospital in Washington, D.C., a lead investigator for clinical studies of the device. “TOMi Scope’s advanced light-based technology could dramatically alter the way children with ear problems are evaluated, enhancing our ability to inform optimal treatments.”

Middle ear infections are the leading cause of hearing loss, surgery and antibiotic use, especially in children. Affecting more than 80% of children, they are misdiagnosed up to 50% of the time using the current gold standard, examination via otoscope.[i] Children can suffer from recurring ear infections for six to 12 months before they are referred to an ENT specialist, and are often prescribed increasingly potent antibiotics during this time. More than one million tube surgeries are performed in the U.S. alone every year.

“Clinicians seeking to be more accurate and confident in their assessment of middle ear fluid and fluid type will find this new technology using light wave detection very helpful,” said Michael Pichichero, M.D., Director of the Rochester General Hospital Research Institute and Research Professor at the Rochester Institute of Technology in New York. “The fact that it works well even in the presence of significant wax build-up is of great value. Wax continues to be a huge problem in middle ear diagnosis.”

“At PhotoniCare we set out to solve the massive problem of frequent misdiagnosis of middle ear infections, and the overuse of antibiotics and referrals to surgery in children that result,” added PhotoniCare co-founder & CEO Ryan Shelton. “We thank the FDA for clearing our TOMi Scope under a new product code unique to our technology, and look forward to bringing this innovation to doctors and patients very soon.”

PhotoniCare expects to immediately launch the TOMi Scope in a limited release in select U.S. geographies, with a full national launch later in 2020.

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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.

Genetron Health Provides Update on HCCscreen™ for Liver Cancer Early Screening in China

Led by the Wuxi municipal government and administered by the National Cancer Center in China, the “Liver Cancer Early Screening Comprehensive Prevention and Control Project” is a public health initiative.

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.