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PolarisAR Receives Clearance from the U.S. Food and Drug Administration for Stellar Knee

Legacy MEDSearch

Food and Drug Administration (FDA). STELLAR Knee not only impacts the surgeon and the patient, but also empowers healthcare providers to change the standard of care.” Food and Drug Administration for Stellar Knee appeared first on Legacy MedSearch | Medical Device Recruiters.

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Health Transformation Alliance Teams up With Cognoa for Autism Diagnostic Device

MedCity News

Cognoa’s Canvas Dx product is authorized by the Food and Drug Administration and assists healthcare providers in diagnosing autism spectrum disorder for children ages 18 months through 72 months. Members of Health Transformation Alliance can now add Canvas Dx to their benefit plans.

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First-in-class biologic approved for rare lung disease

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved WINREVAIR ( sotatercept -csrk) for subcutaneous injection (45mg, 60mg) for adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1). Merck/MSD stated that WINREVAIR is the subject of a licensing agreement with Bristol Myers Squibb.

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Pharma Marketing: A Guide for Healthcare Companies

Pharma Marketing Network

Pharmaceutical marketing is the process of communicating the benefits of a pharmaceutical product to potential patients and healthcare providers. This type of advertising is often used to raise awareness of a new drug or to promote a new indication for an existing drug.

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How do Healthcare AI Developers (and Buyers) Stay Ahead of the Regulatory Curve?

Nixon Gwilt Law

That said, the flurry of regulatory policymaking and legislation, congressional hearings and inquiries, and industry stakeholder organization around the development and deployment of healthcare AI portends major developments in the coming years. HIPAA is the pantheon of healthcare data privacy regulation in the U.S. HIPAA What is it?

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Provention and Sanofi enter deal to launch teplizumab for type 1 diabetes

Pharmaceutical Technology

Provention Bio and Sanofi US have signed a co-promotion agreement to launch the former’s lead investigational drug candidate, teplizumab for the delay in the onset of clinical type 1 diabetes (T1D). The US Food and Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk.

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ISPOR Announces Real-World Evidence Summit 2023

PM360

Program sessions, centered around data quality and fit-for-purpose use, will delve into studies that showcase the utilization and effectiveness of RWE in healthcare decision-making. ISPOR 2023 is scheduled for May 7-10 with the theme, “Impacting Innovation, Value, and Healthcare Decision Making.”