Brisbane, Calif.-based Caption Health Inc. received good news from the U.S. FDA, which has given a thumbs up to Caption Guidance. This software aims to assist medical professionals in the acquisition of cardiac ultrasound images and uses artificial intelligence (AI) to provide real-time guidance. Read More
In a budget proposal sure to spark opposition, the Trump administration has proposed to provide the National Institutes of Health with only $38 billion in fiscal 2021, several billion dollars short of the agency’s funding for the current fiscal year. The proposal also calls for funding of less than $95 billion for the Department of Health and Human Services, a 10% reduction in funding that includes an adjustment for drug pricing proposals and a $5 million cut to FDA monies for the 21st Century Cures Act. Read More
PARIS – Carmat SA, from Vélizy-Villacoublay, France, has obtained full FDA approval for its investigational device exemption application (IDE). The company is now able to initiate a U.S. early feasibility study (EFS) of its total artificial heart. “This full approval to initiate a U.S. study confirms the FDA’s confidence in our ability to conduct a feasibility study of the first bio-prosthetic artificial heart in the United States,” Stéphane Piat, CEO of Carmat, told BioWorld. Read More
The FDA has granted over-the-counter (OTC) clearance to the first noninvasive wearable to treat stress urinary incontinence. The device, known as Innovo, uses electrical stimulation to strengthen pelvic floor muscles and is integrated into fitted shorts. It was already available by physician prescription in the U.S. since an FDA clearance in early 2019. Read More
For depression, and other mental health disorders, the era of precision medicine has yet to arrive.
Symptoms are “very poorly reflective of the underlying biology,” Amit Etkin told BioWorld. Depression can manifest through multiple different symptoms that differ both between and within cultures. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bionano Genomics, Brainsway, Medshape, Tenon Medical. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 7D Surgical, Autobio Diagnostics, Cepheid, China Grand Pharmaceutical and Healthcare Holdings, Co-Diagnostics, Elite Medical Technologies, Endonovo Therapeutics, Future Medical Equipment, Medtronic, Mobidiag, Oncosec Medical, Precisionmed, Probo Medical, Sirtex Medical, Seaspine Holdings, Sona Nanotech, Valeritas Holdings, Zealand Pharma. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Endomag, Nanobiotix, Paragonix Technologies, Rist Neurovascular. Read More
Keeping you up to date on recent developments in cardiology, including: Researchers find 'first responder' that triggers plaques; Heart muscle cells alter their energy source during regeneration; More evidence points to rosiglitazone, heart issues. Read More
