Infant monitoring specialist Owlet's Dream Sock has received CE Mark certification by the European Union, meeting its required safety and health requirements and paving the way for the device to be sold in Germany, France and the U.K. later this year.
The Dream Sock, which wraps around a baby's foot, is a nonprescription medical pulse oximetry solution for infants aged 1 to 18 months weighing 6...
The FDA announced the Apple Watch atrial fibrillation (AFib) tool is qualified for use in clinical trials through its Medical Device Development Tools (MDDT) program, thus enabling researchers to use it to detect arrhythmias or abnormal heart beat.
Apple's tool is the first digital health tool to be qualified under the MDDT program, a voluntary program aimed at evaluating devices for use in...
Philips received a warning letter from the FDA in February, which the Agency posted on Tuesday, stating that an inspection of the tech giant's manufacturing facility in Suzhou, China, that makes CT and ultrasonography systems revealed it was not in compliance with the Quality System Regulation's good manufacturing requirements.
The FDA said an inspection of the facility in October showed the...
The South Korean Ministry of Food and Drug Safety (MFDS) has recently approved two digital devices that assist in respiratory rehabilitation and treatment of vision impairment due to cognitive illnesses.
EasyBreath by Share & Service is a mobile application that provides an eight-week respiratory rehabilitation programme for persons with chronic obstructive pulmonary disease, asthma, and lung...
Israel-based Scopio Labs announced the FDA granted De Novo clearance for its Full-Field Bone Marrow Aspirate (FF-BMA) software that provides AI-enabled decision support tools for bone marrow analysis.
The FF-BMA application allows for bone marrow aspirate analysis. It combines full-field imaging and an AI-powered decision support system that allows hematopathologists to analyze bone marrow...
Digital cardiac and lung disease health startup Eko Health announced it received FDA 510(k) clearance for its AI-enabled cardiac tool that helps with the early detection of low ejection fraction, a key indicator of heart failure.
Eko Low Ejection Fraction Tool (ELEFT), which officially received the green light from the FDA in March, is an AI-enabled tool that allows providers to detect low...
Medical technology firm Hologic has been granted clearance from the FDA to market its Genius Digital Diagnostics System, powered by the company's Genius Cervical AI algorithm.
The digital cytology system – a medical diagnostic tool used to examine cells under a microscope to detect abnormalities or diseases – integrates deep learning-based AI with advanced volumetric imaging technology to aid in...
GE HealthCare received FDA 510(k) clearance for its Novii+ maternal and fetal monitoring solution, which will become available to U.S. customers later in the year.
The device, consisting of a wearable and wireless sensor, enables noninvasive measurement and display of fetal heart rate, maternal heart rate and uterine activity for pregnant patients at or beyond 34 weeks.
With the expanded...
Federal agencies like the FDA and HHS have established safety programs to ensure safe and trustworthy artificial intelligence use in various sectors, including healthcare.
Digital health executives relayed their recommendations, advice, and suggestions for regulators configuring rules around AI use in healthcare to MobiHealthNews, including flagging AI-generated content and building off existing...
Note: Andreessen Horowitz says views expressed by its employees are their own and should not be taken as investment advice. More details at https://a16z.com/disclosures/.
As 2023 comes to a close, Jay Rughani, investment partner at Andreessen Horowitz, joined MobiHealthNews to discuss his takeaways from the year, noteworthy events, recommendations for regulators forming rules around AI in...
