US health regulators will now fast-track devices that check for wound infections
What happened
US health regulators just made it easier to get approval for devices that detect bacterial activity in chronic wounds. This means new diagnostic tools for hard-to-heal wounds can reach patients faster.
Why it matters
For years, getting new medical devices approved was a slow, expensive process, even for relatively simple diagnostic tools. This change means companies can bring new ways to identify wound infections to market without the full, lengthy approval process. It should make it cheaper and faster to develop and deploy these specific types of devices.
The signal
Watch for new companies entering the chronic wound diagnostic market and how quickly their devices get approved and adopted by hospitals and clinics.