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FloBio Receives FDA’s Breakthrough Device Designation for Bleeding Risk Diagnostic Test

Legacy MEDSearch

Food and Drug Administration has granted Breakthrough Device Designation for its rapid bleeding risk diagnostic test. Today millions of Americans use DOACs, a highly effective and widely used drug for managing atrial fibrillation and deep vein thrombosis. DOACs can elevate bleeding risk and complicate emergency care.

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SpectraWAVE Secures 510(k) Clearance to Add Saline Imaging and Expanded Artificial Intelligence Features to the HyperVue™ Imaging System

Legacy MEDSearch

Food and Drug Administration (FDA) 510(k) clearance for product enhancements to the HyperVue Imaging System. is a privately held medical device company founded in 2017 to provide unrivaled optical and computational insights to improve the treatment and outcomes for patients with coronary artery disease (CAD).

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Cardiovascular Medical Device Sales With Marc Toth

Evolve Your Success

In this episode, Samuel Adeyinka interviews Marc Toth , who shares his entrepreneurial journey in the cardiovascular medical device sales industry. I was working with the same physicians I used to sell stents to help them raise money and open their outpatient centers. We syndicate, which means we sell shares for physicians to invest.

Medical 52
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SpectraWAVE Secures 510(k) Clearance of HyperVue™ Intravascular Imaging System

Legacy MEDSearch

a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), today announced Food and Drug Administration (FDA) 510(k) clearance of their flagship intravascular imaging system, HyperVue. SpectraWAVE, Inc., Chief Executive Officer of SpectraWAVE.

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Why aren’t digital pills taking off?

Pharmaceutical Technology

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Proteus Health’s Abilify MyCite had an ingestible sensor that could track if a patient consumed the drug. Proteus’s profile grew considerably; it was soon valued at $1.5