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Rithem Life Sciences Joins Innovators’ Network at American Heart Association Center for Health Technology & Innovation

The Center is focused on building and fostering health technology relationships to develop innovative and scalable solutions.

1st Patients Enrolled in STEM Trial for `Treatment of Chronic Subdural Hematoma

This marks the first patients enrolled in a prospective, randomized, international trial of a liquid embolic agent for the treatment of chronic subdural hematoma (cSDH), a common disease affecting primarily older adults.

Genius AI Detection Receives FDA Clearance – New Deep Learning-based Software Designed to Help Radiologists Detect Subtle Potential Cancers in Breast Tomosynthesis Images

This new technology, 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.

Passio Pump Drainage System Granted 510(k) for Additional Indication for Home Use

The Passio Pump Drainage System consists of the Passio Catheter, a Handheld Control Unit (pump) and a Disposable Collection Kit, which includes a redressing kit, for drainage of recurrent and symptomatic pleural effusion.

Boston Scientific Signs Definitive Agreement to Divest BTG Specialty Pharmaceuticals Business

Boston Scientific notes SERB, backed by private equity firm Charterhouse Capital Partners since 2017, owns a diversified portfolio of prescription medicines focused on rare and life-threatening diseases.

Dascena Receives FDA Breakthrough Device Designation for Machine Learning Algorithm for Earlier Prediction of Acute Kidney Injury

Dascena, Inc., a machine learning diagnostic algorithm company that is targeting early disease intervention to improve patient care outcomes, today announced it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for Previse, the company’s algorithm designed to predict acute kidney injury (AKI) more than a full day before patients meet the clinical criteria for diagnosis. This is the first Breakthrough Device Designation of a cloud-based machine learning algorithm developed for the early detection of AKI.

“Acute kidney injury commonly affects hospitalized individuals, and if not caught early, can result in dangerous outcomes for patients,” said Ritankar Das, chief executive officer of Dascena. “Our machine learning algorithm is able to analyze patient vital sign data and determine whether a patient is at risk of developing acute kidney injury. With this technology, we believe we’ll be able to provide physicians with ample time to intervene and prevent long-term kidney injury in their patients.”

A major challenge in the treatment of AKI is that the clinical criteria for recognition are markers of established kidney damage or impaired function. By predicting whether a patient is likely to succumb to AKI before symptoms present, treatment outcomes could be improved. In validation studies, Previse demonstrated higher sensitivity and predictive value than a clinician’s assessment that relied on clinical criteria, and Previse only utilized patient data that were already routinely collected. In a 2018 paper published in the Canadian Journal of Kidney Health and Disease, Dascena reported that Previse predicted AKI 48 hours before onset with 84% percent accuracy and a diagnostic odds ratio of 5.8.

The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.

Latest Posts

Rithem Life Sciences Joins Innovators’ Network at American Heart Association Center for Health Technology & Innovation

The Center is focused on building and fostering health technology relationships to develop innovative and scalable solutions.

1st Patients Enrolled in STEM Trial for `Treatment of Chronic Subdural Hematoma

This marks the first patients enrolled in a prospective, randomized, international trial of a liquid embolic agent for the treatment of chronic subdural hematoma (cSDH), a common disease affecting primarily older adults.

New England Biolabs Announces Further Expansion of Their RNA Depletion Product Portfolio with the Launch of the NEBNext Custom RNA Depletion Design Tool and NEBNext RNA Depletion Core Reagent...

Together, these enable a fully customizable workflow for improved removal of specific RNAs, including abundant RNAs such as ribosomal RNA

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New England Biolabs Announces Further Expansion of Their RNA Depletion Product Portfolio with the Launch of the NEBNext Custom RNA Depletion Design Tool and NEBNext RNA Depletion Core Reagent...

Together, these enable a fully customizable workflow for improved removal of specific RNAs, including abundant RNAs such as ribosomal RNA

INTERCEPT Blood System for Cryoprecipitation Receives FDA Approval States Cerus Corporation

The system is used to produce Pathogen Reduced Cryoprecipitated Fibrinogen Complex for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. 

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

Establishes joint venture with Wuxi municipal government; Expects the commercialization and revenues of HCCscreen to accelerate in China.

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.