FDA consults on AED (automatic external defibrillator) reclassification as access grows
This article was originally published in Clinica
Executive Summary
The US FDA is seeking comment on its planned reclassification of automatic external defibrillators (AEDs) from class III (high risk) to class II (medium risk), with the potential to greatly expand the market for the device. Class III devices must be approved for market via a premarket approval (PMA) application, whereas class II enables the device to be cleared via the 510(k) process.
You may also be interested in...
News We’re Watching: AI Safety Partnership; Boston Scientific Recalls; New Cancer, STI Tests; VR
This week, the US and UK announced a partnership to promote AI safety. Boston Scientific recalls embolic agent. LumiCell received FDA approval for its imaging agent to detect residual cancer. Scout receives an award to develop an STI test; and Osso VR leverages the Apple Vision Pro for VR medical training.
Finance Watch: Canaan, Regeneron Reveal New Funds For Start-Ups
Private Company Edition: Regeneron launched a $500m venture fund and Canaan added $100m, bringing the venture firm’s recent total to $1bn-plus. Also, incubators plan to grow over the next decade and in recent financings Avenzo raised $150m and Nvelop launched with $100m.
Pink Sheet Podcast: Leqembi Spending, Woodcock’s Next Act, Pneumococcal Vaccine Development
Pink Sheet editors discuss Medicare spending projections for the Alzheimer’s treatment Leqembi, Janet Woodcock’s new post-FDA role, and ongoing preparations for new pneumococcal vaccines that will reach the market soon.