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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.

Beckman Coulter’s PK7400 Automated Microplate System Receives 510(k) FDA Clearance

Beckman Coulter today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its PK7400 Automated Microplate System and the system’s reagents have completed FDA approval.

Designed for use in blood donor and plasma centers, as well as large reference laboratories, the PK7400 Automated Microplate System offers the industry’s highest throughput for a single analyzer in its class and is now available in countries across Europe, Canada and the United States.

According to the AABB (formerly the American Association of Blood Banks), an estimated 33,000 units of blood are needed each day to meet patient need. However, the organization also stated, more than 4,000 blood donation events have been cancelled due to the COVID-19 pandemic.

“Blood donation is critically important under normal circumstances, as one donation can save up to three lives, but even more so now,” said Shamiram R. Feinglass, M.D., MPH, chief medical officer, Beckman Coulter. “During this challenging time, those that are feeling well and healthy should continue to make and keep donation appointments to help ensure life-saving blood is available for patients that need it most.”

“Along with the need for physical donors, blood donation and plasma centers require tools that enable them to reliably test and process the samples that are coming in, so they can quickly make them available for patients,” said Kathleen Orland, vice president and general manager of Beckman Coulter’s Chemistry and Immunoassay business. “Our PK7400 is designed to optimize workflow, minimize hands-on time and increase productivity, allowing users to focus their time on protecting the health and safety of donors, patients and blood center staff.”

The PK7400 Automated Microplate System:

  • Offers the industry’s highest throughput for a single analyzer in its class, processing up to 300 samples per hour with a maximum of 12 tests per sample
  • Includes proprietary liquid and ready-to-use reagents
  • Provides the end user the ability to test multiple assays in a single batch without decreasing the throughput
    • The assay menu includes ABO blood grouping, Rh typing, weak D testing, Rh-Kell phenotyping, as well as syphilis and CMV qualitative screening

“The PK7400 is a user-friendly analyzer with the capacity to test a large throughput with rapid, accurate results,” said Christie Garza, laboratory specialist at Gulf Coast Regional Blood Center. “The software is easy to navigate, and results can be interpreted quickly and easily.”

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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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...