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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.

Getinge Receives 510(k) Clearance for Servo-air® Mechanical Ventilator

US Food & Drug Administration (FDA) clears Servo-air® mechanical ventilator for use with adult and pediatric patients dependent on intensive care ventilation expanding upon the Servo family of products available in the United States for decades.

“FDA 510(k) clearance for Servo-air® mechanical ventilator will broaden our US offering with a turbine-driven ventilator,” says Eric Honroth, President, North America at Getinge. “The Getinge Servo platform holds a leadership position in the US marketplace, further expanding Getinge’s global ventilation business.”

Servo-air® is a high performing ventilator intended for adult and pediatric patients and includes both Invasive and Non-Invasive (NIV) ventilation modes, including High Flow Therapy and Servo Compass options. Various modes allow clinicians to adapt and personalize ventilation to the patient and situation.

Honroth adds, “Servo-air has the same proven easy to use interface with the same context-based guidance as the Servo-u ventilator.”

Servo-air is turbine-driven and independent from wall gas that allows for powerful, uninterrupted, quiet ventilation benefitting the intensive care patient. Servo-air is ideally suited for intra-hospital transport, intermediary, or intensive care. Dual, hot-swappable batteries allow set up anywhere in the intensive care unit with powerful performance and optimal endurance.

Mechanical ventilation is a key component in the ongoing fight against COVID-19. “In partnership with intensive care clinicians, Getinge’s Servo-air can help save lives in the US market,” Honroth concludes.

Servo-air is expected to be available in the US in late 2020.

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.