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MEDICAL DEVICE NEWS MAGAZINE

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ACC Issues Guidance to Address New Nonstatin Therapies

To address the current gaps in expert guidance related to the recent development and commercial availability of newer nonstatin agents, the American College of Cardiology published today an expert consensus decision pathway on the role of nonstatin therapies for LDL-C lowering in the management of atherosclerotic cardiovascular disease (ASCVD) risk reduction.

The document provides guidance on clinical scenarios not covered in the 2018 AHA/ACC Guideline on the Management of Blood Cholesterol and refines criteria for treating individuals determined by baseline LDL-C levels. The clinical policy focuses on individuals at very high-risk as well as not very high-risk of future ASCVD events, individuals currently with or without a clinical diagnosis of familial hypercholesterolemia, primary prevention for individuals with and without diabetes, and individuals with statin-associated side effects. The writing committee also addresses factors to consider in the clinician-patient discussion reinforcing patient preference with regard to the addition of nonstatin therapies.

The 2022 ACC Expert Consensus Decision Pathway on the Role of Nonstatin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Diseases Risk will publish online in the Journal of the American College of Cardiology on Thursday, August 25, 2022, at 2:00 p.m. ET. It was endorsed by the National Lipid Association.

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Signum Surgical Secures Additional €2.9 Mil

Funds to support ongoing regulatory submissions and clinical programs leading to the commercialization of BioHealx reports Signum Surgical.

Elevation Spine, Inc. Closes $11 Million Series B Financing

Elevation Spine plans to use the proceeds from the financing to ramp the commercial production of Saber-C® as well as support product development of future product extensions of the company’s Saber® Technology platform of products.

Tuned Raises $2.5M Seed Round to Radically Upend the Status Quo in Hearing Care

Tuned advised the funding was led by Idealab NY and Elements Health Ventures.
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