Remove 2017 Remove FDA Remove Food and Drug Administration Remove Sales
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
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. The FDA recognizes that the device will provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

Insiders

Sign Up for our Newsletter

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

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 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.

FDA 52
article thumbnail

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.

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

Sanofi and AstraZeneca’s RSV antibody shows mettle in real-world results

Pharmaceutical Technology

Nirsevimab is still undergoing regulatory review in the US, with the US Food and Drug Administration (FDA) accepting the Biologics License Application (BLA) for nirsevimab in January 2023. Nirsevimab is a long-acting antibody being jointly developed by Sanofi and AstraZeneca as per an agreement made in 2017.

article thumbnail

MSD secures full approval for Keytruda’s use in MSI-high solid tumours

Pharmaceutical Technology

The PD-1 inhibitor received an accelerated approval for this indication back in May 2017. The drug is approved in several indications, including advanced melanoma, metastatic non-small cell lung cancer (NSCLC), and relapsed classical Hodgkin lymphoma (cHL). In 2022, the company reported Keytuda sales of $20.9 billion in 2028.