The first filing to emerge from Identifyher Ltd. seeks to gain protection for a wearable sensor that women can wear daily to track potential symptoms of perimenopause, providing them with data that can be used to find the right management plan for their needs.
The first patenting from Fibra Inc. sees its founder and CEO Parnian Majid describe their development of a non-invasive wearable device which tracks fertility data through the measurement of various physiological parameters.
Mental tech startup Doctorpresso Co. Ltd. launched an audio journaling mobile application called Redi, in South Korea, as a voice analysis software capable of detecting depression through artificial intelligence-aided speech analysis.
Researchers from the University of Chicago and Northwestern University have filed for protection of an mobile application to track individualized patient needs, engagement in continuous positive airway pressure machine use, and the correlation of risk behaviors to determine sleep apnea treatment progress.
France is tightening access to the reimbursed health care market for digital medical devices. The national Digital Healthcare Agency (ANS) reported that a standard interoperability and safety system for digital medical devices is coming into force.
German regulators have unveiled their initial report covering the prescription and deployment of reimbursable health apps. The survey was carried out by Hamburg-based health insurance fund Techniker Krankenkasse (TK) in conjunction with Bielefeld University in North Rhine-Westphalia and health care economics analysis research bureau Vandage GmbH, also based in Bielefeld.
The U.S. FDA handed good news to Healthy IO Ltd. (Healthy.io) with 510(k) clearance for its smartphone-based Minuteful Kidney test, making kidney function testing – from sample to result – possible at home. The app calculates the albumin-to-creatinine ratio (ACR), a key indicator of kidney disease. By enabling people to complete the test using their phones, the company says it has increased the rate of testing in high-risk patients by 50%.
The U.S. Federal Trade Commission (FTC) has been moving aggressively on privacy issues in connection with health data in the past two years, but the agency has issued an advisory of sorts to collectors of these data points. The FTC said July 11 that it intends to crack down on violators in an effort to protect data privacy.
Kranus Health GmbH has raised $6.5 million in series A funding to ramp commercialization of its digital therapy for treating erectile dysfunction (ED). Eleven European investors participated in this fundraising. The round was led by early-stage health care venture capitalists Karista SAS, while Peak Pride Management GmbH also joined the funding round.
The U.S. FDA has given Resapp Health Ltd. the green light for its 510(k) Sleepcheckrx app to detect moderate to severe sleep apnea in adults as a prescription-only software-as-a-medical device. The FDA cleared the app as a class II medical device. Brisbane, Australia-based Resapp submitted the 510(k) premarket notification to the FDA in November 2021 for Sleepcheckrx for at-home sleep apnea screening.