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THE TAPE
Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register
The Directory // Digital Health & SaMD

Digital Health & SaMD

Software as a medical device, AI decision support and digital therapeutics. 10 companies listed.

Tel Aviv, Israel  ·  Est. 2016  ·  Series D+  ·  $500M+ raised  ·  510(k) cleared

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.

Natick, MA  ·  Est. 2009  ·  Public  ·  PMA approved

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.

Boston, MA  ·  Series B  ·  $132M+ raised  ·  510(k) cleared

Beacon Biosignals makes the Waveband EEG headband and AI sleep-staging software, and sells brain-function biomarkers to drug developers.

San Francisco, CA  ·  Est. 2019  ·  Series B  ·  $55M raised  ·  510(k) cleared

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.

Boston, MA  ·  Unknown

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.

Cambridge, MA  ·  Est. 2016  ·  Series C  ·  Breakthrough designation

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.

Malmö, Sweden  ·  Est. 2016  ·  Series A  ·  PMA approved

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.

Melbourne, Australia  ·  Est. 2018  ·  Unknown

Builds software based therapeutics delivered through healthcare providers for gastrointestinal conditions such as irritable bowel syndrome.

San Francisco, CA  ·  Est. 2021  ·  Unknown

Building phone based monitoring and management for heart rhythm medications, founded by electrophysiologist and bioengineer Rachita Navara.

Mountain View, CA  ·  Seed  ·  $18M raised  ·  510(k) cleared

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.

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