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...
AI-enabled protein design company Profluent has leveraged artificial intelligence to design an open-source gene editor called OpenCRISPR-1, demonstrating the technology can be used to create molecules with the power to edit human DNA.
Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) technology, developed more than a decade ago, allows scientists to modify DNA sequences within...
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...
Value-based cancer care platform Thyme Care is launching Enhanced Supportive Care, a virtual palliative care support program to assist its members and caregivers with managing physical and psychological symptoms accompanying cancer diagnosis and treatment.
The program will be led by Dr. Julia Frydman, the company's first medical director for palliative care. Frydman previously worked in the...
TeleRare Health announced its launch to offer virtual care appointments for individuals with rare diseases, focusing on diagnosis, disease assessment and ongoing care.
The platform connects patients with expert clinicians and offers molecular diagnostics, as well as care coordination and referral services. It also provides information on approved therapies for rare diseases and patient advocacy...
Boston-based wearable fitness company WHOOP announced it expanded its language offerings and global footprint, now shipping to 56 markets worldwide, including Hong Kong, Bahrain, Korea, Saudi Arabia, Qatar, Israel, Taiwan and Kuwait.
WHOOP's wearable health tracker collects physiological data on heart rate, sleep, recovery and strain. Users also have the option to track their menstrual cycle. Its...
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...
The head of Microsoft's AI for Good Lab, Juan Lavista Ferres, coauthored a book providing real-world examples of how artificial intelligence can responsibly be used to positively affect humankind.
Ferres sat down with MobiHealthNews to discuss his new book, AI for Good: Applications in Sustainability, Humanitarian Action and Health. He talked about ways to mitigate biases within data input in AI...
Baby tech company Owlet and telehealth staffing and services company Wheel announced they are partnering to allow Wheel's clinicians to prescribe caregivers Owlet's medical pulse oximetry wire-free sock for infants.
Owlet's BabySat, which received FDA clearance last year, uses pulse oximetry technology to monitor a baby's heart rate and oxygen saturation level, and alerts caregivers when a...
