Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Invivoscribe.
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.
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).
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.
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.
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.”
A new mouse model of an inherited form of dystonia has shown the spinal cord is the driver of the condition, overturning previous understanding that the movement disorder is caused by disruption of neural circuits in the brain. The connection was demonstrated by selectively deleting torsin family 1 member A (TOR1A), the gene that causes dystonia, in the neurons of the spinal cord only.
A new urine test from Convergent Genomics Inc. correctly predicts bladder cancer as early as 12 years before clinical symptoms occur, new data presented at the 2023 American Urological Association annual meeting shows. The Uroamp test, which can be administered at home and in point-of-care settings, could increase survival rates and help to reduce health care costs.
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