More than 1.6 million spinal procedures are performed in the U.S. each year and between 10% and 30% of them fail to achieve their objective, indicating that the field has abundant room for improvement. Both equipment manufacturers and the FDA hope to improve spinal surgery success rates as seen in two clearances granted on May 31.
The transformation of cardiology continues with two U.S. FDA actions to promote the use of artificial intelligence (AI): a 510(k) clearance for Rapidai Inc.’s pulmonary embolism (PE) triage and notification product and breakthrough device designation for Anumana Inc.’s pulmonary hypertension (PH) early detection algorithm.
Isono Health Inc. received FDA clearance for its Automated Three-dimensional Ultrasound with Artificial intelligence (ATUSA) system for breast imaging, a wearable, compact automated whole breast ultrasound system that can acquire high-quality images without requiring a skilled operator. The ultrasound scan takes two minutes to scan the entire breast volume and offers 3D visualization of the breast tissue.
Yes, getting FDA 510(k) clearance for your medical device is something to cheer about. But consider Arterys Inc. It just reported its eighth FDA clearance, this time for a next generation, deep learning cardiac analytics platform. The Cardio AI’s purpose, Arterys CEO John Axerio-Cilies told BioWorld, is to leverage artificial intelligence (AI) and deep learning for analysis of cardiac MRI images that is faster, more accurate and repeatable than ultrasound and other imaging modalities.
The U.S. FDA’s safety and performance-based pathway (SPBP) is intended as a leaner, meaner alternative to the conventional 510(k) pathway that would sidestep some of the presumed problems with the concept of substantial equivalence. The agency recently added four device types to this program, including orthopedic fracture fixation plates.
The FDA program for third-party review of 510(k) applications was designed to take some of the load off the agency’s review staff and thus allow the agency to focus on more complex filings, but recent data suggest that the program has had only a modest effect on the FDA’s workload. The number of third-party reviews for the current and two previous fiscal years only modestly exceed the numbers from fiscal years 2018 and 2019, a conspicuous trend given the distractions at the FDA’s device arising from its work to manage the COVID-19 pandemic.
Israeli startup Sanolla Ltd. won U.S. FDA 510(k) clearance for its smart-infrasound stethoscope Voqx. The artificial intelligence (AI)-based device is the first stethoscope cleared by the U.S. FDA to detect infrasound and audible information to identify clinical conditions. The auscultation capabilities are designed to support early assessment of cardiopulmonary conditions.
Ossio Inc. has received FDA clearance for Ossiofiber suture anchors used to fix soft tissue to bone in the shoulder, foot and ankle. This is the most recent of clearances for the company’s intelligent bone regeneration technology which began in 2019 as a possible alternative to permanent fixation implants for the foot and ankle alone.
Merit Medical Systems Inc. received FDA 510(k) clearance for the Scout Bx delivery system, which enables the placement during stereotactic and MRI-guided biopsy of a reflector to guide breast surgery. The delivery system works with the company’s Scout reflector, a wire-free radar localization device.
The U.S. FDA has given the green light to a pelvic organ prolapse (POP) repair device developed by Misgav, Israel-based Escala Medical Ltd. The mesh-free, non-surgical repair system is designed to anchor sutures to ligaments of the pelvic floor in an incision-free procedure. Escala, which is a portfolio company of Israeli government franchised incubator Trendlines Group Ltd., believes the device will help the 1 in 5 women in the U.S. affected by POP.
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