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...
A federal jury found three former executives of health tech company Outcome Health guilty of multiple counts of fraud on Tuesday.
Rishi Shah, cofounder and former CEO, Shradha Agarwal, former president, and Brad Purdy, former chief operating officer and chief financial officer, were convicted for their roles in a $1 billion scheme that defrauded investors and clients, largely pharma companies....
Butterfly Network, maker of a handheld, smartphone-connected ultrasound system, received FDA 510(k) clearance for its Auto B-line Counter that leverages AI to help providers determine if a patient has abnormal lung function by measuring B-lines.
B-lines on an ultrasound appear as bright lines and can be associated with various pulmonary conditions, such as chronic obstructive pulmonary disease...
Digital health technology company NeuroRPM has received FDA 510(k) clearance for its AI-enabled remote monitoring app that utilizes an Apple Watch to track common Parkinson's symptoms such as bradykinesia, tremor and dyskinesia.
Bradykinesia is slowness of movement, and dyskinesia is involuntary or erratic movements.
The Washington D.C.-based company's algorithms are embedded in the Apple Watch...
Sen. Elizabeth Warren (D-Mass.) is urging the Federal Trade Commission to scrutinize CVS Health's planned acquisition of Medicare-focused primary care provider Oak Street Health.
In a letter to FTC Chair Lina Khan and Commissioners Alvaro Bedoya and Rebecca Slaughter, the progressive senator wrote the deal could lower quality of care and hike costs.
She also pointed to other acquisitions – ...
Virtual primary care company TytoCare received FDA 510(k) clearance for clinical decision support software that analyzes lung sounds for possible wheezing.
Tyto Insights for Wheeze Detection uses TytoCare's stethoscope to evaluate lung sounds and identify recordings that suggest wheezing in adults and children ages 2 and older. It prompts a clinician when wheezing is suspected.
The software...
The Federal Trade Commission has started cracking down on digital health companies for allegedly sharing consumers' health data for advertising purposes.
Last month, the agency said GoodRx had shared personal health information with third parties like Google and Facebook. The company, best known for its drug-cost transparency tools, agreed to pay a $1.5 million fine to settle the case, but...
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