Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allovir, APR, Arvelle, Astrazeneca, BMS, Innocoll, Intercept, Jazz, Orphan Technologies, Pear, Recordati, Relief.
Like so many other ventilator providers in recent days, Resmed Inc. has committed to ramping up production. It aims to triple its ventilator output and multiply its ventilation mask production by 10. But the San Diego-based company’s specialty is not mechanical ventilation that requires intubation, which is most commonly used in the intensive care unit (ICU), although it does produce some of those.
The surge of interest in testing for the COVID-19 pathogen has led to some innovative tests and test strategies, including at-home tests. However, the FDA has indicated that it is wary of both at-home testing and specimen collection in other than supervised settings, a policy that is meeting with criticism from some quarters, but not all.
PARIS – With more than 10,000 people now infected, 3,626 hospitalized and 450 having died, France is in third place of European countries most affected by the coronavirus epidemic, after Italy (35,700 cases) and Spain (13,910 cases). The exponential spread of COVID-19 has led to a surge in demand for respiratory therapy equipment in intensive care units.
Astrotech Corp., of Austin, Texas, has a broad range, having developed mass spectrometers in agriculture and manufacturing and selling chemical analyzers for use in the airport security and other applications. Now, it is looking to help in the fight against COVID-19.
San Jose, Calif.-based Align Technology Inc. has won the FDA’s nod for its Itero Element 5D imaging system. The company said the Itero Element 5D is the first intraoral scanner with near-infrared imaging (NIRI) technology that visualizes the internal structure of the tooth in real time. The FDA cleared the device for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ArcherDX, Eurobio Scientific, Extremity Medical, Perkinelmer.