Digital Health & SaMD
Software as a medical device, AI decision support and digital therapeutics. 10 companies listed.
Sells FDA-cleared AI triage and quantification software for CT and X-ray through its aiOS platform, now built on the CARE foundation model. More than 30 510(k) clearances since 2018.
Allurion makes a swallowable gastric balloon that needs no endoscopy or anesthesia and passes on its own after about four months. It pairs the balloon with a remote care app and scale.
Beacon Biosignals makes the Waveband EEG headband and AI sleep-staging software, and sells brain-function biomarkers to drug developers.
Bunkerhill Health develops FDA-cleared AI algorithms that find cardiovascular and bone disease on imaging and ECGs ordered for other reasons. Hospitals run them through its Carebricks platform.
Runs a risk management network that health systems use to assess vendors, products and medical devices, covering third-party, enterprise and AI governance risk. The vendor catalog covers tens of thousands of products, so device makers are assessed through it.
Builds Spectris, a prescription home-use device that delivers gamma frequency light and sound stimulation for Alzheimer's disease. The device holds Breakthrough Device designation and is in the HOPE trial ahead of an FDA submission.
Flow Neuroscience makes a home-use tDCS headset paired with a behavioral therapy app for depression. It has sold in the UK and Europe since 2019.
Builds software based therapeutics delivered through healthcare providers for gastrointestinal conditions such as irritable bowel syndrome.
Building phone based monitoring and management for heart rhythm medications, founded by electrophysiologist and bioengineer Rachita Navara.
UpDoc makes prescription software that collects diabetes data from patients through a voice and chat agent. It issues insulin dosing instructions within parameters set by the prescriber.
New clearances, funding rounds and regulatory moves for device founders. No noise, no login.
You're in. The next morning brief lands in your inbox.