In February, Viewray Inc. said it expected to post 25% to 40% revenue growth this year. By April, the company said delays in installations would cut growth to 0% to 15% and it announced it was pursuing strategic alternatives with Goldman Sachs. Less than a month later, on May 10, the company withdrew its guidance entirely citing “the current market conditions and ongoing strategic process.”
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A subcommittee of the U.S. House Ways and Means Committee met to review the status of policies for novel medical devices and drugs, but a partisan rift was immediately evident at the hearing. House Democrats were generally in favor of more drug price negotiation power for the federal government and opposed to immediate Medicare coverage of breakthrough medical devices while Republicans generally steered in the opposite direction, suggesting that drug and device makers should not expect clear legislative sailing over the course of the 118th Congress. Read More
Creative Balloons GmbH has changed its name to Advanced Medical Balloons GmbH and is bringing its fecal management system, Hygh-tec, to the U.S. market after receiving clearance from the U.S. FDA. Hygh-tec is a microscopically thin polyurethane balloon catheter system which enables reliable, sealed access to the colon preventing fecal leakage from patients in intensive care units. Read More
Aidoc Medical Ltd. has just presented a study using its AI tool in the Netherlands Cancers Institute for detection and worklist prioritization to diagnose incidental pulmonary embolism at routine contrast-enhanced chest CT. The results published in Radiology: Cardiothoracic Imaging show a reduction by 15% of the missed rate of incidental pulmonary embolism and by more than 98% of the notification time for positive incidental pulmonary embolism. “Our AI system gives a response related to the interpretation, quantification and workflow management,” Elad Walach, co-founder and CEO of Aidoc Medical, told BioWorld. Due to the growing volume of radiology examinations, particularly in thoracic imaging, and the lack of supply radiologists, the delay between the CT examinations and their interpretation has increased significantly in many practices. This is particularly true for pulmonary embolism (PE). Read More
A method for parallel sequencing of single-cell extrachromosomal circular DNA (ecDNA) and full-length mRNA transcriptomes has enabled new insights into the roles of ecDNA in cancer progression, researchers from Charité hospital and the Max Delbrück Center for Molecular Medicine reported in Nature Genetics on May 8, 2023. Circular DNAs are present in at least a third of cancer cells, and their presence correlates with poor prognosis in many cases. They can carry driver genes that have separated themselves from their chromosome of origin, and some research suggests that they serve as “reserve copies” of driver genes. Boundless Bio Inc. is in phase I trials targeting ecDNAs. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Boehringer, Cue, Healthy.io, Lifenet, Lumen Bioscience, Medical Manufacturing, Providence, Signifier, Somex, Venus Concept. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Invivoscribe. Read More
