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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.

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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. The FDA recognizes that the device will provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

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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 clearance follows prior receipt of Breakthrough Device Designation from FDA. Subsequent to receiving Breakthrough Device Designation and 510(k) clearance from FDA, the U.S.

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Lumendi Receives 510(k) Clearance for Two New Devices

Legacy MEDSearch

Food and Drug Administration (FDA) 510(k) clearance for DiLumen EZ¹, a single-use, disposable endotherapy device for endoscopic mucosal resections (EMR) and difficult colonoscopies. Since 2017, clinicians in the U.S., Connecticut-based medical device innovator Lumendi, LLC announced that it has received U.S.

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NICE recommends AbbVie’s/J&J’s Imbruvica for combo use in untreated CLL

Pharmaceutical Technology

CLL is regarded as the most common type of leukaemia in England where 3,157 patients were diagnosed with the disease in 2017, based on the institute’s announcement. Brukinsa was approved by the US Food and Drug Administration (FDA) in CLL in January 2023. While Imbruvica sales were $3.78 billion in 2029.

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What Pear Therapeutics’ Bankruptcy Has Left the DTX Industry to Ponder

MedCity News

Bringing the very first prescription digital therapeutic (PDT) to market in 2017, Pear Therapeutics went above and beyond to follow suggested regulatory guidelines, obtained Food & Drug Administration (FDA) clearance, and provided solid clinical study evidence.

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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., About SpectraWAVE, Inc.