US FDA Authorizes Breakthrough Device For Stroke Patients
The agency has granted de novo authorization to Neurolutions’ IpsiHand System to help stroke victims rehabilitate the use of their upper extremity.
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In this week’s podcast, senior reporter Ferdous Al-Faruque gives an early look at how user fee negotiations between the US FDA and industry groups for MDUFA V are unfolding. As in the past, the parties are at odds over how much industry should pay, and what the FDA is using the money for.
Sternum recently announced a partnership with Medtronic to protect its legacy devices from cybersecurity threats. Medtech Insight chatted with its CEO Natali Tshuva about how her product works.
Developer Of First US OTC COVID-19 Antigen Test Plans 'Digital Diagnostics For Multitude Of Infectious Diseases'
The developer of the OTC at-home antigen test — the first of its kind to get an emergency use authorization from the FDA – received more than $200m from the US government to manufacture in the US. So what’s next for Ellume? In this Q&A, the Australian company’s CEO, Sean Parson, explains.