In July 2017 the US FDA (Food and Drug Administration) launched its Digital Health Innovation Action Plan to provide Americans “timely access to safe and effective digital health products,” many of which are being developed using artificial intelligence technologies.



A key component of the Digital Health Innovation Action Plan is the innovative Software Precertification (Pre-Cert) Pilot Program, which a number of AI-based digital health projects have already completed, spiking FDA AI Med approvals in 2018. Synced takes a look at some of these companies and their FDA 510(K) clearance and Premarket Approval (PMA) AI-empowered medical product innovations.

Innovations in Diabetes Research

IDx is a technology company applying AI in medical diagnostics. In April 2018 the company received FDA premarket approval (PMA) for its product IDx-DR, an AI diagnostic system that detects signs of diabetic retinopathy in retinal images. The device leverages the power of AI algorithms to analyze medical images of eyes to determine if treatment is required.



Medtronic is one of the world’s largest medical device companies. In March 2018, the Dublin-based company announced their Guardian Connect SGM system had passed FDA authorization. Guardian Connect CGM System is a smart technology that continuously measures patient glucose levels and predicts changes, integrating the company’s latest diabetics prediction algorithm with the Guardian (TM) Sensor 3 for glucose level monitoring. Medtronic says the system has reached 98.5 percent accuracy in predicting glucose levels.



DreaMed Diabetes is a medical tech company offering AI solutions and support for enhancing insulin therapy. Last June the company received FDA authorization to sell its software product DreaMed Advisor Pro in the US. DreaMed Advisor Pro is a decision-support tool for real-time personalized medicine that can quickly and automatically determine optimal treatment for maintaining balanced glucose levels.

Innovation in Cerebral Disease Treatment

Viz.AI is a healthcare startup aiming to solve challenges related to strokes. In February 2018 Viz.AI received FDA clearance for its Viz LVO software. LVO uses artificial intelligence and deep learning technology to automatically identify suspected LVOs on CTA imaging of patients, and can send an immediate alert to the appropriate on-call physician.



Aidoc is an AI startup developing full-body imaging software. Last August Aidoc received FDA clearance for the first product in its AI-based workflow optimization solution, which helps radiologist flag acute intracranial hemorrhage (ICH) cases in head CTs. Aidoc decision-support software is based on advanced healthcare-grade AI and analyzes medical imaging to provide comprehensive solutions for detecting acute abnormalities across the body. The software can help radiologists prioritize life-threatening cases and expedite patient care.



Empatica is a Boston-based tech company designing and developing wearable devices for medical research and epilepsy management. In February 2018, the company’s AI band Embrace received FDA clearance. Embrace is a wearable smartband that uses machine learning to detect unusual patterns that may be associated with convulsive seizures, and can alert caregivers immediately.



MaxQ AI is an AI company that develops software using artificial intelligence to interpret medical images such as CT scans. MaxQ AI received FDA 510(k) clearance for its product Accipio Ix in November 2018. Accipio Ix is an AI software that identifies suspected brain bleeding in CT scans and prioritizes critical cases for clinical assessment.

Innovations in Cardiovascular Diseases

Zebra Medical Vision is a healthcare startup developing tools that help radiologists make the next leap in patient care. Last July Zebra received FDA 510(k) clearance for its Coronary Calcium Scoring algorithm, which automatically calculates coronary calcium scores based on standard, non-contrast Chest CTs. The tool can provide early detection of high risk for severe cardiovascular events.



Lepu Medical is a Beijing-based healthcare company working in medical devices, drugs and services. Last November its subsidiary Carewell received FDA approval for its AI-ECG Platform, a diagnostic program that covers major cardiovascular diseases and can detect arrhythmias (abnormal impulse formation, impulsive conduction abnormalities), atrioventricular hypertrophy, myocardial ischemia, and myocardial infarction.



Verily is an Alphabet subsidiary focusing on developing medical devices. Verily received FDA 510(k) clearance for the on-demand ECG feature of its Study Watch smartwatch; which can record, store, transfer and display single-channel ECG rhythms. The feature is indicated for use by healthcare professionals, adult patients with known or suspected heart conditions, and other at-risk or health conscious individuals.



Apple, the world leading electronics, PC and software company, received FDA clearance for features of its Apple Watch Series 4 in September 2018. The ECG app enables users to take an electrocardiogram directly from their wrist. The wearable device can capture heart rhythms when users experience symptoms such as rapid or skipped heartbeat.

Innovations in other medical scenarios

Imagen is an American healthcare startup using artificial intelligence. In May 2018 the FDA cleared its OsteoDetect software for detecting wrist bone fractures. OsteoDetect uses machine learning techniques to identify signs of distal radius fracture during review of posterior-anterior and medial-lateral x-ray images of the wrist.



Subtle Medical is a healthcare startup applying AI in medical imaging workflow. Last December the company’s first product, SubtlePET received FDA 510 (k) clearance. SubtlePET is an AI-powered medical image process platform that allows hospitals and imaging centers to enhance images for faster scans, improving patient experience during imaging procedures.



Cognoa is a Silicon Valley consumer healthcare company focusing on children’s health development technologies. In February 2018, Cognoa received FDA clearance for its Class II autism diagnosis app. The AI platform uses machine learning to evaluate children’s health status, detect signs of autism, and provide insights to help physicians with clinical diagnostics.



Heathy.io is a healthcare company that uses AI and smartphone cameras to provide healthcare innovations. In July, 2018, the company’s home-based smart urinalysis kit Dip.io received FDA 510 (k) clearance as a Class II medical diagnostic device. The kit is built around an established urinalysis dipstick which measures 10 parameters indicating a range of infections, chronic illnesses and pregnancy-related complications.



Excel Medical is a healthcare company that aims “to make predictive analytics an actionable process.” The company’s WAVE platform received FDA clearance in January 2018. WAVE is a patient surveillance and predictive algorithm platform that collects physiological data in near real-time and integrates it into an EMR. The data is automatically risk-stratified and communicated as a read-at-glance pie-chart on communication devices used by multidisciplinary clinical teams.