A landmark, real-world study in the U.K. has demonstrated that combining whole genome sequencing with clinical data enabled tailored cancer treatment and improved outcomes. At one health care center, having DNA sequence data led to changes from usual standard of care in 25% of cases. “Mostly, [patients] got into clinical trials; some got medicines they wouldn’t have got. Others avoided medicines because their genetic make-up suggested that if they were exposed to the medicines, they would be at risk of harm,” said Mark Caulfield, professor of clinical pharmacology at Queen Mary University of London, who is co-author of a paper outlining the findings in Nature Medicine, Jan 11, 2024.
The U.S. Patent and Trademark Office (USPTO) published new enablement guidelines Jan. 10 to provide more consistency across technologies to ensure patent applications truly enable the breadth of their claims in keeping with the Supreme Court’s unanimous decision last year in Amgen Inc. v. Sanofi SA.
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.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AIRS Medical, Cleerly, Carl Zeiss, Zeta Surgical.
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.
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.
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