U.K.-based digital health tech company Huma has received FDA 510(k) Class II clearance for its configurable disease-agnostic Software as a Medical Device platform, which includes the company's cardiovascular risk score algorithm.
The company, which received EU MDR Class IIb certification just three months ago, obtained FDA clearance in partnership with Health Canada through the FDA's joint eStar...
Italy-based healthcare agency, consultancy and digital health group, Healthware, and the Digital Therapeutics Alliance, a nonprofit organization based in Virginia that provides thought leadership and education to advance digital therapeutic adoption, today announced the release of a report outlining policy pathways for digital health adoption in Europe.
Alberta Spreafico, managing director of...
Home diagnostics company Cue Health announced its received FDA de novo authorization for its at-home COVID-19 test, dubbed the Cue COVID-19 Molecular Test.
The Cue COVID-19 Molecular Test detects genetic material from the SARS-CoV-2 virus. It consists of a nasal swab, or Cue Sample Wand, and a Cue Cartridge Reader. After taking the test, adults with respiratory infection symptoms receive the...
GE HealthCare announced it received FDA 510(k) clearance for its Precision DL deep learning image processing software.
Precision DL utilizes deep learning, a subset of AI and machine learning, to improve image quality on the company's PET/CT, Omni Legend, and allows for faster scanning time and improved small lesion detection. The software is the company's latest addition to its Effortless Recon...
Editor's note: This article has been updated to reflect iHealthScreen has submitted but not yet received 510(k) clearance for iPredict.
iHealthScreen, maker of AI-enabled software for retinal imaging, has submitted its iPredict Eye Screening System, which leverages AI to help providers determine if a patient over 50 has age-related macular degeneration, for FDA 510(k) clearance.
The iPredict...
Since Pear Therapeutics, one of the earliest digital therapeutic companies, declared bankruptcy in April, there's been discussion surrounding the state of investments in digital therapeutics, challenges that exist around standards of care, barriers to adoption and how to achieve success in the sector.
Andy Molnar, CEO of the Digital Therapeutics Alliance, a nonprofit organization that provides...
Sibel Health, spun out of Northwestern University, announced it received a new FDA 510(k) clearance for its ANNE One platform to include continuous neonate and vital sign monitoring of infants born at any gestational age up to 2 years old.
The ANNE One platform allows for this vital sign monitoring via a clinical-grade wearable in two parts: the Anne limb, which measures skin and body temperature...
Tech giant Samsung Electronics announced it received FDA clearance for its Health Monitor app's Irregular Heart Rhythm Notification (IHRN) feature.
IHRN works with the app's electrocardiogram function to monitor heart rhythms suggestive of atrial fibrillation, an irregular heart rhythm. If AFib is detected, the Galaxy Watch prompts the user to take an ECG with the Watch.
The feature will be...
Casana, maker of a health monitoring smart toilet seat, announced this week it had received its first FDA 510(k) clearance.
The startup's Heart Seat received the agency green light for monitoring heart rate and oxygen saturation in adults at least 22 years and older who weigh 90 to 350 pounds. Casana said the battery-powered seat can run for several years without recharging, sending health data...
After years of slow movement advancing telehealth, remote patient monitoring and other digital health technologies, the landscape changed rapidly during the COVID-19 pandemic, said Jodi Daniel, managing director of Crowell Health Solutions.
At HIMSS23, Daniel, who previously served as the founding director of the Office of Policy in the Office of the National Coordinator for Health Information...
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