Tag: USFDA news

Sequana Medical’s IND application to begin the phase 1/2a MOJAVE study with DSR 2.0 to treat congestive heart failure has been approved by the US FDA.

The US Food and Drug Administration (FDA) has approved Sequana Medical NV’s investigational new drug (IND) application for its second-generation DSR product (DSR 2.0) for the treatment of congestive heart failure. Sequana Medical NV is a pioneer in the treatment…

New US FDA certifications for Abbott’s life support system will enable medical professionals to treat more seriously ill patients.

The US Food and Drug Administration (FDA) recently granted Abbott two more clearances for the company’s market-leading life support system. The CentriMag Blood Pump for use with the CentriMag System is now approved for longer-term usage in adults where extracorporeal…

To evaluate the PEF rate of lung function in asthma patients, Tenovi develops a cellular remote Peak Flow Metre that has been approved by the US FDA.

Tenovi offers Tenovi, a leader in US FDA-approved remote patient monitoring (RPM) solutions, recently announced the release of its cellular-enabled remote Peak Expiratory Flow Metre (PFM). The device enables asthma sufferers to quickly communicate peak expiratory flow rate (PEF) and…

In persons with certain forms of adjuvant liver cancer, Roche reports that the Tecentriq + Avastin phase III IMbrave050 research lowers the likelihood of the cancer coming back.

Avastin (bevacizumab) plus Tecentriq (atezolizumab) showed a statistically significant improvement in recurrence-free survival (RFS) in patients with hepatocellular carcinoma (HCC) at high risk of disease recurrence following liver resection or ablation with the intention of curing the disease, according to…

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