The draft Medicare physician fee schedule for calendar year 2025 provoked a strong backlash from physician societies due to a net cut in physician pay. Device makers have their own concerns, including the latest in a series of controversies over coverage of skin substitutes.
Avicenna.ai SAS received U.S. FDA clearance for its Cina-Cspine algorithm, which uses machine learning technology to detect and triage cervical spine fractures from computed tomography images. The tool automatically flags imaging findings that are compatible with acute cervical spine fractures, which can cause serious neurological damage or paralysis.
The U.S. CMS believes it has a quandary on its hands with regard to transitional pass-through payment for renal denervation devices, but the Medical Device Manufacturers Association urged the agency to provide separate payment mechanisms for these devices as seen in the inpatient final rule.
Australia’s Health Department has released the final report of the Health Technology Assessment (HTA) Review that makes 50 recommendations for improving access to new health technologies while tackling inequity, simplifying HTA processes and making it easier for consumers and clinicians to participate.
The med-tech sector maintained its momentum in the second quarter, with total financings climbing 16.5% to $7.47 billion, compared to $6.41 billion in Q1.
Artificial intelligence is beginning to make its way into the world of medical device design, but Gregg Van Citters, senior consultant at Medicept, told BioWorld that there are both opportunities and tripwires on the road ahead.
Epitomee Ltd. happily swallowed the news of U.S. FDA clearance for its capsule for weight management, an ingestible medical device for adults who are overweight or obese. Designed for use along with diet and exercise, the capsule expands in the stomach to create a feeling of fullness that lasts up to six hours.
The U.S. Department of Health and Human Services reported the winners of the Leading Edge Acceleration Projects in Health Information Technology program, with a couple of key areas of interest.
The U.S. FDA cleared Senseonic Holdings Inc.’s Eversense 365, the first continuous glucose monitor to last a full year with a single sensor rather than the 10 days to two weeks typical for wearable sensors such as those offered by Abbott Laboratories and Dexcom Inc.
With an eye on shutting down national security threats and securing American innovation, the U.S. House overwhelmingly passed the Biosecure Act Sept. 9 with a vote of 306-81. The next stop on the bill’s path to enactment is a Senate vote and, if it gets that, then on to the president’s desk.
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