article thumbnail

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.

article thumbnail

ABM Respiratory Care Announces the FDA Clearance of the Biwaze Clear System

Legacy MEDSearch

Food and Drug Administration (FDA) 510(k) clearance of the BiWaze ® Clear System. Founded in 2017, ABM Respiratory Care is dedicated to advancing patient care by developing intelligent, clinically differentiated and innovative respiratory care solutions to help people breathe better inside and outside the hospital.

FDA 95
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Novel oral chemotherapeutic holds potential for stomach cancer patients

European Pharmaceutical Review

Several lifestyle factors have been shown to increase the risk of developing stomach cancer, including alcohol consumption, smoking and consuming foods preserved by salts. There is an urgent need for more effective chemotherapy treatments with less severe toxicity and side effects. New hope for stomach cancer patients.

article thumbnail

Ceribell Receives FDA 510(k) Clearance and CMS NTAP Reimbursement for New ClarityPro™ Software with Electrographic Status Epilepticus Diagnostic Indication

Legacy MEDSearch

Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE).  The Ceribell EEG System first received FDA 510(k) clearance in 2017 and is commercially available in the United States. Ceribell, Inc.

FDA 52
article thumbnail

Pharma within planetary boundaries

European Pharmaceutical Review

In addition, the number of active substances detected in the environment has been increasing with unknown consequences for ecosystems and the accumulation of substances in food chains. Therefore, another question is how we can obtain reliable, transparent information on older drugs.

Pharma 83
article thumbnail

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).

article thumbnail

Cancer: Progress but a long way to go

World of DTC Marketing

In recent years, early detection and treatment improvements have helped boost the 3-year survival rate for lung cancer from 21% in 2004 to 31% in 2015 through 2017. Medicare spent nearly $600 million over three years to pay for cancer care involving four drugs later found to provide no clinical benefit for some forms of the disease.