First Filing Acceptance for an Anti-PD-1 Therapy in Cervical Cancer
IDx, a privately held AI diagnostics company, announced today that it has filed its De Novo submission to the FDA for IDx-DR, an AI-based system for the autonomous detection of diabetic retinopathy — a leading cause of blindness. The FDA has granted IDx-DR with a “Breakthrough Device” designation, which means the submission will receive expedited review.
Researchers from the University of California San Diego have developed a low-cost, single-use tattoo-like wearable that measures the user’s glucose levels. According to a release from the institution, this noninvasive technology will be at the center of a newly announced pilot clinical trial designed to test the accuracy and acceptability of the tattoos.
Highlighting the ubiquity and importance of smartphones across multiple industries, a new report by ACT | The App Association indicated that two out of three businesses utilize enterprise apps. And many of those opportunities are rising up throughout the healthcare industry.
The mHealth app, designed by researchers at the Worcester Polytechnic Institute, helps obstetric care providers identify perinatal depression in soon-to-be and new mothers and gives them care management tips.
It's no secret that respiratory drugs make up a crowded field, and forthcoming generics will make the competition tougher still. AstraZeneca's Symbicort is no stranger to the fallout, either, what with payers pressing prices and new rivals grabbing share.
Common Sensing , an evidence-based, data-driven injectable-medicine healthcare company, announced the close of a $6.6 million USD Series A financing. The round was led by Waterline Ventures. New World Health, Royal Philips (NYSE: PHG; AEX: PHIA), and Haselmeier joined the round as well. The funds will be used to accelerate Common Sensing's manufacturing and commercial operations for Gocap™, an IP-protected dose monitoring solution enabling patients and providers to better utilize injectable medicine, including insulin, fertility medications, growth hormones, and others.
A new report in JAMA Internal Medicine by University of Sydney and Bond University scholars weighs the risks and benefits of a recent change to blood pressure guidelines in the US.
The FDA confirmed in a March 16, 2012 communication released to Bloomberg News that the vaginally placed pelvic mesh product known as the Prolift, sold by Johnson & Johnson subsidiary Ethicon, Inc. since March, 2005, was initially marketed without any clearance or approval from the FDA.
The FDA today approved the first medical device to harness artificial intelligence for the detection of diabetic retinopathy in adults who have diabetes.
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