Heartstream wrapping up clinical study of user-friendly, biphasic external defibrillator.
This article was originally published in The Gray Sheet
HEARTSTREAM CLINICAL STUDY FOR USER-FRIENDLY BIPHASIC EXTERNAL DEFIBRILLATOR is expected to be completed early this year, the company says. The clinical trial, involving 200 patients at 12 sites, is currently under way and has "very clearly" demonstrated the efficacy of the automatic external defibrillator (AED), Heartstream President and CEO Alan Levy said Jan. 10 at the Hambrecht & Quist life sciences conference in San Francisco. Heartstream plans to file a 510(k) for the defibrillator before the end of this year.
You may also be interested in...
Second read-out maintains 94% level of efficacy, with a very early signal that it could outperform Pfizer’s rival mRNA candidate in preventing severe cases.
The French major and Regeneron have racked up another indication for Dupixent with the blockbuster getting approval in Europe to treat children with severe eczema.
Russia says it will make the first deliveries of its $10-per-dose Sputnik V vaccine in January, while international regulators say vaccine trials should continue for as long as possible to generate longer-term evidence on their benefits and risks. A UK research body has stressed that drugs repurposed for COVID-19 also need to undergo thorough safety and efficacy testing as reports suggest the UK regulator could approve a vaccine within days.