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.
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.
Orchestra Biomed Holdings Inc. randomized the first patient in the BACKBEAT pivotal study investigating the use of its atrioventricular interval modulation (AVIM) therapy as a treatment for patients with uncontrolled hypertension implanted with a Medtronic plc pacemaker. AVIM therapy is an investigational patented bioelectronic therapy designed to immediately and durably reduce blood pressure.
Boehringer Ingelheim GmbH partnered with Newcastle University and the University of Edinburgh to fund a £30 million (US$38 million) study into liver cirrhosis in a bid to provide scientists with new insights into liver health. The partners hope that the study will not only enhance the understanding of nonalcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH) cirrhosis, but also help identify translational biomarkers using a cutting-edge approach called single-cell RNA sequencing to accelerate the development of future therapies.
Medtronic plc received CE mark for its latest miniature, leadless pacemakers, the Micra AV2 and Micra VR2. According to the company, they are the world's smallest pacemakers, provide a longer battery life, and are easier to program than previous Micra pacemakers, while maintaining the benefits of their predecessors such as reduced complications compared to traditional pacemakers.
Cardiomech AS raised $13 million in fresh capital via a convertible loan agreement that will go towards developing its transcatheter mitral valve chordal repair technology. The round was heavily oversubscribed, indicating investors' expectations that the company’s technology may be a first-line therapy for patients suffering from degenerative mitral regurgitation.
Intravascular lithotripsy generally scores well for removal of calcification, but the U.K. National Institute for Health and Care Excellence (NICE) is offering only limited endorsement of this procedure for peripheral artery disease (PAD). NICE said one of the problems with the evidence is that this procedure is often conducted in conjunction with other procedures, and thus the agency will have to see more definitive evidence before an unequivocal endorsement is justified.
Carmat SA recently reported a software update for its bioprosthetic total artificial heart Aeson device that will significantly improve its safety profile. In the past, the company had to suspend implantations of its device following issues around quality. With the enhancements, the Aeson software will be able to detect signals of malfunctions in real time and adapt the control of the prosthesis so that its performance is not affected.
Echoing trends seen last year, the med-tech industry concluded 2023 with a continued surge in deal value juxtaposed against a more substantial decline in M&A value. Deal value for the year, including licensings, collaborations and joint ventures, reached $10.63 billion from 1,656 deals, the highest annual value in BioWorld’s records.
Vectorious Medical Technologies Ltd. is seeking patent protection for a method for predicting the occurrence of a heart condition by receiving a multiple measurements of blood pressure acquired in a patient’s heart.
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