Latest News

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.

BreviTest Technologies Advises Their COVID-19 IgG Antibody Test Received Permission for Commercial Distribution by FDA

September 3, 2020

BreviTest Technologies announced that the FDA has officially accepted BreviTest’s official notification of its intent to commercially distribute its IgG antibody test under policy outlined in Section IV.D. of the Policy for Coronavirus Diseases – 2019 Tests.

The BreviTest SARS-CoV-2 IgG Test detects the presence of SARS-CoV-2 specific IgG antibodies in plasma or serum using only 3μl of sample. Reliable results are available in 10 minutes. A positive test result indicates prior exposure to the virus and potential immunity.

The BreviTest team performed a blinded clinical validation study using 111 human samples (serum or plasma), including 33 presumed positive samples from patients with PCR-confirmed COVID-19 infection, and 78 presumed negative samples collected prior to the pandemic. The BreviTest system classified each sample accurately, resulting in 100% sensitivity (positive predictive agreement) and 100% specificity (negative predictive agreement). BreviTest’s application for Emergency Use Authorization (EUA) for this test is currently under review at FDA. Assay validation for IgG quantitation and fingerstick collection is currently underway.

“The combination of high accuracy, small sample volume, and automated result reporting make this assay especially helpful for community surveillance as we head back to school and work,” said Dr. Atul Varadhachary, CMO of BreviTest and Managing Partner at Fannin Innovation Studio.  “Quantitation of IgG has been identified as a priority by FDA, and we are especially excited about completing validation of a finger-stick semi-quantitative IgG assay that can be performed in the field.”

The BreviTest system can perform complete laboratory-quality ELISA tests without the need for additional infrastructure. Technicians or nurses only need to add a drop of sample to a disposable cartridge and insert it into the portable Acuity™ analyzer. The system is designed to test a variety of analytes, including proteins, small molecules, and serum antibodies.

BreviTest’s developed its technology backed by private funding from Fannin Innovation Studio and research support from the National Institutes of Health (NIH).  Most recently, BreviTest received a $1.5 million SBIR award from the National Institute on Drug Abuse (NIDA) to develop rapid opioid urine testing for opioids. With the immediate need for rapid and reliable antibody testing, BreviTest expanded its product focus to include diagnostics related to the COVID-19 pandemic.

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.

Don't Miss

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...