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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.

GE Healthcare to Distribute Osprey Medical’s Technology to Address Angiography Based Acute Kidney Injury

GE Healthcare and Osprey Medical today announced a strategic alliance under which GE Healthcare will exclusively distribute Osprey’s product portfolio in Europe, Russia, Middle East, Africa, Central Asia and Turkey. Osprey’s DyeVert™ contrast minimization devices, complemented by GE Healthcare’s range of iodinated x-ray contrast media, offer healthcare professionals a technology platform to address the rising problem of Acute Kidney Injury (AKI) following interventional coronary angiograms in patients with Chronic Kidney Disease (CKD).

Osprey’s President and CEO, Mike McCormick, stated: “We are pleased to be partnering with GE Healthcare to commercialize our products in global markets to address the rising problem of AKI following heart imaging procedures in patients with poor kidney function.”

“GE Healthcare and Osprey share a similar goal rooted in improving patient outcomes” added Kevin O’Neill, President and CEO of GE Healthcare’s Pharmaceutical Diagnostics business. “Both our product portfolios and educational efforts, which are aligned with cardiology guidelines for AKI minimization, offer interventional cardiologists the opportunity to safely image patients by reducing the risk of AKI,” concluded O’Neill.

AKI is sudden damage to the kidneys that causes them to not work properly. It can range from minor loss of kidney function to complete kidney failure.1 With one out of four angiography patients presenting with CKD,2 the risk for these patients to develop AKI is a serious concern for catherization labs and hospitals. Patients with impaired kidneys are at a significantly increased risk for negative outcomes and for longer hospital stays.3 The European Society of Cardiology and European Association for Cardio-Thoracic Surgery have issued joint guidelines for the reduction of AKI.4 These guidelines recommend that physicians should screen patients for risk of AKI, ensure they are properly hydrated, consider patient appropriate contrast choice and minimize the contrast volume delivered to the patient. Osprey and GE Healthcare’s portfolios are aligned with these guidelines so that healthcare professionals can help minimize AKI complications in patients with CKD.

Osprey’s technology is the only FDA cleared medical device that is indicated for reducing patient contrast exposure. The DyeVert portfolio allows healthcare providers to monitor cumulative dye dose specific to each patient’s kidney function determined prior to the procedure.

GE Healthcare’s Pharmaceutical Diagnostics unit develops and supplies imaging agents used to support approximately 90 million procedures per year globally, equivalent to three patients every second. Its range of products include iodinated X-ray contrast media used in interventional and other diagnostic procedures including coronary angiography.

The four (4) year exclusive distribution agreement enables GE Healthcare to commercialize Osprey’s products within the Region. During the term of this agreement necessary commercial terms have been discussed and agreed. As Osprey develops new products GE Healthcare will be granted a right of first refusal to distribute and promote these products in the Region.


References:

1. Acute kidney injury. National Health Service Website. https://www.nhs.uk/conditions/acute-kidney-injury/. Accessed September 10, 2018.
2. Tsai TT, Patel UD, Change TI, et al. Contemporary incidence, predictors, and outcomes of acute kidney injury in patients undergoing percutaneous coronary interventions. JACC. Cardiovasc Inter. 2014;7:1-9.
3. Subramanian S, Tumlin J, Bapat B, Zyczynski T. Economic burden of CIN: implications for prevention strategies. J Med Econ. 2007;10:119-134.
4. Neumann FJ, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. European Heart Journal (2019) 40; 87-165.

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

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