Who this is for

Founders, first regulatory hires, and the engineers who end up writing the submission. The audience is device startups from concept through the first years on the market, plus the investors, consultants and regulators around them.

What we cover

Three kinds of thing. News: Newly Cleared reports the 510(k), De Novo and PMA decisions that matter, backed by a tracker of every decision from the last 12 months; Fundraising follows the rounds; M&A follows the exits, with the terms where they are public; Regulatory tracks FDA guidance, policy and enforcement that change what a submission needs; and the Cybersecurity desk carries a stage-by-stage walk-through of what FDA's premarket cybersecurity guidance asks for, alongside headlines syndicated from MedDeviceCyber.com, which covers device security full time. How-to: evergreen guides on the cybersecurity half of a submission and the rest of it, pathway, Pre-Sub, software documentation and fees. Resources: a free library of editable submission templates, checklists and procedures. Find a Startup is a working directory of device companies by category.

How we work

Every story links to a primary source: the FDA record, the company release, the filing. Tracker data comes from FDA's own databases through openFDA and is refreshed with every rebuild. We write for people who already know the acronyms, so we do not pad. Corrections happen in the open.

The directory

Listing is editorial and does not imply endorsement. Companies enter from FDA filings, funding announcements, accelerator cohorts and reader tips. FDA status is derived from the tracker where an applicant name matches; funding figures are public numbers only.

Sponsored placements are purple and labeled. Sponsors do not write the editorial and do not review it before publication. Anything purple on this site is paid for. Everything else is not.

Contact

Tips, corrections and directory submissions: tips@meddevicestartups.com. Sponsorship: partnerships@meddevicestartups.com. Read the security desk at MedDeviceCyber.com.