Biosense Webster Inc. scored approval from Japan’s Ministry of Health Labour and Welfare’s (MHLW) for its Varipulse pulsed field ablation platform to treat symptomatic drug-refractory recurrent paroxysmal atrial fibrillation on Jan. 9., making it the first PFA system approved in the country.Read More
Intravascular ultrasound is the preferred imaging modality for a number of procedures conducted on the circulatory system, including some procedures performed in the peripheral vasculature, but adoption is seen in some quarters as sub-optimal. A trio of medical journals have published a consensus statement pressing the case for more widespread utilization of IVUS for peripheral artery disease, but one of the sources of drag is poor Medicare reimbursement, a problem that might only be resolved in a piecemeal fashion. Read More
Listening to conversations between a mother and her unborn child on the cellular level could inform how the pregnancy is going and prevent complications. Three scientific groups from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), in collaboration with Wayne State University and Michigan State University, have used single-cell RNA sequencing techniques to decipher these words, identify the cellular language of these interactions in the placenta and establish a cellular atlas. Read More
Privacy laws and enforcement in the U.S. are seemingly growing by the week on both the state and federal levels, with the Federal Trade Commission (FTC) serving as one of the players in the federal enforcement game. The FTC has released a statement warning developers of data that are working as model-as-a-service companies to be wary of any illicit uses of data acquired to assist in development of artificial intelligence algorithms, a warning that these developers and their customers would do well to heed. Read More
Ultromics Ltd. joined forces with Pfizer Inc. to expedite U.S. FDA clearance of its artificial intelligence (AI)-enhanced platform to aid early diagnosis of cardiac amyloidosis, also known as stiff heart syndrome. The company received FDA breakthrough device designation last year for Echogo Amyloidosis, which uses deep AI to analyze echocardiograms and detect the presence of cardiac amyloidosis, a serious condition often missed during standard heart assessments. Read More
The first patenting from Mhealthcare Inc. describes a patient examination table or bed equipped with a variety of sensors, data from which may be analyzed with trained machine learning models to facilitate risk assessment and diagnosis of non-neurotypical developmental conditions such as autism in infants and young children by predicting cognitive, behavioral, social and developmental outcomes as early as the first three months of life. It is also claimed that the table may be used to diagnose epilepsy and Alzheimer’s disease. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ab Medica, Cardiofocus, Clinical Trial Service, Dnanexus, Galvanize, Hawthorne Effect, Intelliseq, Identifai-Genetics, Karl Storz, Innersight Labs, Labcorp, MCRA, Medical Microinstruments, Myriad, Neurologica, PCM Trials, Reflexion, Spectral AI. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AIRS Medical, Cleerly, Carl Zeiss, Zeta Surgical. Read More
