No. 23The Anatomy Lesson · Omnira SignalOnline

Medical device clearance leads for launch services

A medical device company gets its premarket clearance.

On the record

611

devices cleared to companies you can reach

Where
United States, 90 days
Same pull
176 companies clearing their first device ever
Pulled

The moment

A clearance letter is public the week it posts, and the months after it are launch work: the device listing, the quality system, packaging and sterilization at volume, a sales channel, the first trade shows. The company has to line all of that up.

The Anatomy Lesson tracks every new clearance, keeps the companies you can reach and flags the ones clearing their first device ever. Each one comes with the device, its class, its review panel and the company's full clearance history.

Who it's for

  • Contract manufacturers
  • Regulatory and quality consultants
  • Distributors and independent sales reps
  • Sterilization and packaging houses
  • Device marketing agencies
  • Clinical and post-market CROs
  • Product-liability insurance brokers

What you get

  • Devices cleared to reachable companies in your window
  • First-time clearers, flagged
  • The device, its class and its review panel
  • The company's whole clearance history
  • Household-name device makers and prolific filers set aside

The outcome

Your contract manufacturing team calls a first-time company the week its clearance posts, before it's signed anyone for volume. Your distribution reps see new devices sorted by specialty.

Questions buyers ask

Is a clearance the same as approval?
No. A clearance is a finding that the device is substantially equivalent to one already cleared. It isn't a launch date or a sale, and we never call it one.
Why do first-time companies matter?
They don't have a quality system, a packaging line or a channel yet. Everything's still to set up. In the last pull, 176 companies cleared their first device ever.
Why is the newest decision older than the pull date?
Decisions post weekly with a lag, so the newest one on file won't match the day we pulled. The window runs to the last decision date.

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