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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.

STAAR Surgical Announces CE Mark Approval for the EVO+ Visian ICL with Aspheric (EDOF) Optic

STAAR Surgical Company, a leading developer, manufacturer and marketer of implantable lenses and companion delivery systems for the eye, has received CE Mark for its EVO+ Visian ICL™ with Aspheric (EDOF) Optic, for commercialization in the European Union from its Notified Body, DEKRA.

STAAR Surgical notes the EVO+ Visian ICL with Aspheric (EDOF) Optic is STAAR’s next-generation lens. The lens is surgically implanted and works in harmony with the patient’s eye to correct vision.  Unlike traditional contact lenses that are placed on the surface of the eye, the EVO Visian ICL family of lenses is positioned inside the eye between the iris and the natural lens where it stays indefinitely.

The EVO+ Visian ICL with Aspheric (EDOF) Optic is indicated for the correction or reduction of hyperopia and myopia between +3.0 diopters and -18.0 diopters. These lenses  include CentraFLOW® technology, a central port that allows the flow of aqueous humor, thus eliminating the need for peripheral iridotomies.

The EVO Visian ICL family of lenses offers premium refractive outcomes with efficiency and comfort for both the patient and the surgeon.  Approximately 285,000 lenses from the EVO Visian ICL product family have been implanted globally to date.  Clinical data show that the EVO Visian ICL provides outstanding, predictable correction of a broad range of refractive errors, with the vast majority of patients achieving and maintaining 20/20 or better visual acuity through five years of follow up.1 Review of the peer-reviewed published literature demonstrates an excellent safety profile: specifically, eight studies, including data from 1,291 eyes followed for up to five years, describe a zero incidence of significant complications.2

Caren Mason, President and CEO, notes, “We are very pleased with the CE Mark approval for the EVO+ Visian ICL with Aspheric (EDOF) Optic. We plan to introduce this lens to a select group of surgeons for Early Effectiveness Observational use. This beta analysis is designed to elicit surgeon feedback on their experience with the EVO+ Visian ICL with Aspheric (EDOF) Optic including overall performance, patient acceptance, and practice development.  This represents an important new treatment option for eligible patients between 21 and 45 years of age living with nearsightedness or farsightedness.  This approval reinforces our deep commitment to patients seeking visual freedom, as we continue to build our growing EVO Visian ICL portfolio,” concluded Caren.

Clinical Trial for Presbyopic EVO+ Visian ICL Beginning this Year

As reported recently, the first-in-man clinical trial for the EVO+ Visian ICL lens designed for the correction or reduction of presbyopia is underway and continues to be promising.  “Earlier this week, we hosted leading global surgeons at our new STAAR Technology Center, sharing the science behind our Collamer material technology and early findings of our Presbyopic initial clinical trial.  The surgeons were pleased with this investigational use only preview and impressed with the data.  Later this year, we plan to initiate the pivotal clinical trial supporting the applications for the new EVO+ Visian ICL for correction or reduction of presbyopia,” added Ms. Mason.

1. Shimizu K, Kamiya K, Igarashi A, Kobashi H. Long-Term Comparison of Posterior Chamber Phakic Intraocular Lens With and Without a Central Hole (Hole ICL and Conventional ICL) Implantation for Moderate to High Myopia and Myopic Astigmatism. Medicine. 2016 Apr;95(14):e3270.
2. Packer M.  Meta-Analysis and Review: Effectiveness, Safety and Central Port Design of the Intraocular Collamer Lens (ICL).  Clinical Ophthalmology, 2016;10;1059-1077.

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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.

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...

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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...

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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.