Recent U.S. FDA actions could transform decades of prostate cancer care. Two companies focused on prostate cancer received good news from the FDA for their artificial intelligence (AI)-driven software. Bot Image Inc. gained FDA clearance for its medical device computer-aided detection and diagnostic tool, Prostatid. The agency also provided FDA investigational device exemption for Avenda Health Inc.’s Focalpoint ablation system that enables more accurate mapping of a patient’s prostate cancer for better surgical results.
The U.S. FDA granted digital therapeutics company Bodyport Inc. 510(k) clearance for its heart monitoring weight scale. The digital solution includes sensors and algorithms that measure hemodynamic biomarkers to assess heart function and fluid status when patients take their daily weight. San Francisco-based Bodyport told BioWorld the platform is for heart failure (HF) patients in the U.S.
The FDA granted Adherium Ltd. 510(k) clearance for its next-generation Hailie sensor that connects with Glaxosmithkline plc’s Ellipta inhaler to enable monitoring of medication use for asthma and chronic obstructive pulmonary disorder (COPD).
The U.S. FDA handed good news to Healthy IO Ltd. (Healthy.io) with 510(k) clearance for its smartphone-based Minuteful Kidney test, making kidney function testing – from sample to result – possible at home. The app calculates the albumin-to-creatinine ratio (ACR), a key indicator of kidney disease. By enabling people to complete the test using their phones, the company says it has increased the rate of testing in high-risk patients by 50%.
Rapid point-of-care (POC) diagnostics company Lumos Diagnostics Holdings Pty. Ltd. saw its stock plummet 65% on the news that the U.S. FDA rejected its Febridx 510(k) because the device was not substantially equivalent to the predicate device.
The U.S. FDA’s third-party review program for 510(k) filings has perhaps never quite lived up to expectations that this program would take a significant load off the FDA’s shoulders, and the latest quarterly report does nothing to detract from that perception.
The U.S. FDA has given Resapp Health Ltd. the green light for its 510(k) Sleepcheckrx app to detect moderate to severe sleep apnea in adults as a prescription-only software-as-a-medical device. The FDA cleared the app as a class II medical device. Brisbane, Australia-based Resapp submitted the 510(k) premarket notification to the FDA in November 2021 for Sleepcheckrx for at-home sleep apnea screening.
Shares in Acutus Medical Inc. (NASDAQ:AFIB) are trading 50% higher after the arrhythmia management company reported the launch of an expanded suite of its Acqcross left-heart access products. The Carlsbad, Calif.-based company received an expanded U.S. FDA clearance for its Acqcross Qx system for use with Natick, Mass.-based Boston Scientific Corp.’s Watchman left atrial appendage closure (LAAC) device.
The FDA has rejected Artrya Ltd.’s 510(k) application for its Salix coronary anatomy (SCA) software that analyzes heart computed tomography scans via artificial intelligence (AI) to better diagnose coronary artery disease. “The FDA has advised that the Artrya Salix product is not equivalent to the predicate device,” Artrya CEO John Barrington told BioWorld.
Just three months after raising $10 million from its IPO on the Paris Euronext Growth market, SMAIO SA (Software Machines and Adaptive Implants in Orthopedics) obtained U.S. FDA 510(k) clearance for its Balance Analyzer 3D surgery planning software and for its patient-specific union rods. This spinal realignment planning software uses medical imaging of the patient’s spine in an upright static position.
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