Company intelligence
Innolitics
We create and FDA-clear SaMD.
About Innolitics
We are medical device software experts. We help companies develop new medical device software and clear it with the FDA. Our team includes expert software developers, AI/ML experts, cybersecurity experts, and US FDA experts. We've built and cleared over 60 medical devices (SaMD and SiMD) over the past 12 years. See our website for our services and solutions.
Verified activity
Signals from Innolitics
9 published signals
Customers & Market
Innolitics ran a case study where a company spent close to 14 months with a fragmented setup and no clearance, running it as one scope and getting cleared in nine with a fixed price and two deficiencies.
Reported by J. David Giese
Legal & Regulatory
Innolitics announced that Heartvue.Proton, a cardiac MRI analysis platform built by Jeff Dendy and the Heartvue team, was cleared under FDA 510(k) with a 5.5-month first submission and a Predetermined Change Control Plan included.
Reported by Innolitics
Legal & Regulatory
Innolitics achieved FDA 510(k) clearance for Heartvue Proton, an AI-powered cardiac MRI analysis platform built by Heartvue AI team Dr. Jeffrey Dendy.
Reported by Yujan Shrestha, MD
People
Innolitics submitted about seven months later, and the team had me back for two more projects since.
Reported by J. David Giese
Capital & Finance
Innolitics IPO'd its first product at over 70 million dollars in 11 days after regulatory clearance.
Reported by J. David Giese
Products & Services
Innolitics cleared its first product in regulatory clearance in June.
Reported by J. David Giese
People
Innolitics asked candidates who weren't a match for the regulatory roles to stay in touch as they grow.
Reported by J. David Giese
People
Innolitics planned to hire two people but ended up hiring five after a strong candidate pool.
Reported by J. David Giese
People
Innolitics opened applications for a Senior Regulatory Affairs Specialist and a Principal Regulatory Consultant in early August to expand the regulatory affairs team.
Reported by J. David Giese