Roche to Distribute Sepsis ImmunoScore from Prenosis
Roche will commercially distribute Prenosis Inc's Sepsis ImmunoScore, the first-ever FDA De Novo authorized AI diagnostic tool for sepsis.
Roche will commercially distribute Prenosis Inc's Sepsis ImmunoScore, the first-ever FDA De Novo authorized AI diagnostic tool for sepsis.
According to Imvaria, the device’s manufacturer, the clearance signifies the first FDA authorization of a diagnostic tool of any type in lung fibrosis.
The sensor, which measures heart and breathing rate from patients’ GI tract, could also enable early detection of conditions like asthma and COPD.
Mount Sinai’s newly developed ventilatory burden offers a potentially more effective alternative to the traditional AHI in assessing severity in sleep apnea patients.
Read MoreThe US FDA has granted 510(k) clearance to the alveoair digital spirometer, according to a press release by the manufacturer, alveofit.
Read MoreLUNGevity Foundation has launched an Early Lung Cancer Center to accelerate the development and broad adoption of early detection and treatment options.
Read MoreA UC San Francisco-led study finds the current definition of chronic tobacco-related lung diseases leaves patients undiagnosed and untreated.
Read MoreThe latest blood gas analyzers on the market from Instrumentation Laboratory, Nova Biomedical, Radiometer America, and Siemens Healthineers.
Read MoreNew research suggests that despite showing clear symptoms of COPD, many African Americans are not officially diagnosed with the disease due flaws in diagnosis methods.
Read MoreThe company announced a voluntary field corrective action to address complaints of endobronchial combustion occurring when laser-compatible bronchoscopes are used during therapeutic procedures in combination with laser therapy equipment or argon plasma coagulation.
Read MoreThe clearance allows FebriDx to be marketed in the United States for use by healthcare professionals as an aid in the diagnosis of bacterial acute respiratory infection and differentiation from non-bacterial etiology in patients presenting in urgent care or emergency care settings.
Read MoreA newly developed PET imaging agent can non-invasively identify pulmonary fibrosis in its early stages, reducing the need for unnecessary biopsies and allowing patients to begin treatment sooner.
Read MoreCaire’s Fenom Pro fractional exhaled nitric oxide (FeNO) device can now be upgraded to include a 6-second test mode available for ages 6 and up.
Read MoreThe tool, which has been granted FDA Breakthrough Device Designation, is being developed to serve as adjunct in assessment of ILD, potentially avoiding expensive, invasive surgical testing.
Read MoreAccording to Hologic, the test will be a critical tool this upcoming season to help clinicians determine which respiratory virus or coinfection patients have to better inform the best course of treatment.
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