Sustaining healthy weight loss is about so much more than cutting calories or injecting drugs, as many GLP-1 users are finding out. Withings SA continues to expand its obesity care management ecosystem and the capabilities of its connected scale to support patients through their weight loss journey and their lives after reaching goal, potentially addressing the vexing problem of patients rapidly regaining all – and often more – weight once they discontinue the drugs.
Mode Sensors AS received U.S. FDA 510(k) clearance for its Re:Balans hydration monitoring system. The wearable patch sensor allows for the continuous monitoring of body hydration to detect fluid imbalances using thoracic bioimpedance technology to deliver automatic, accurate data to help physicians in fluid management.
India’s Central Drugs Standard Control Organization (CDSCO) posted a draft guidance for medical device software, providing some clarity about the agency’s expectations for this class of products even if it seems to break no new ground.
Staar Surgical Co. reported on Oct. 24 that it had adjourned its special meeting of stockholders scheduled in connection with its proposed $1.5 billion sale to Alcon AG in the face of objections from some of its major shareholders and at least three proxy firms.
The largest study ever conducted on light therapy for Parkinson’s disease has found that long-term use of Symbyx Biome Pty Ltd.’s non-invasive, at-home photobiomodulation (PBM) devices significantly improved mobility, anxiety, and overall symptom severity.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arthrolense, Baird Medical, Biolab, Pulse Biosciences, Smart Reporting, Terraplasma Medical, Waldemar Link.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Edge Medical, Neuraxix, Terumo.
With the number of beats Boston Science Corp. has posted in recent years, it could be auditioning as a heavy metal drummer. Third quarter results kept up the streak, with overall sales 2% ahead of consensus at $5.07 billion and earnings per share of 75 cents, 5% above the Street’s expectations. The company’s two market-transforming products, Watchman and Farapulse, led the strong across-the-board performance, which would be no surprise by now except when looking at the stunning growth rates and sales both posted in the same quarter last year.
It has been a positive year for med tech compared to previous years, said Antoine Papiernik, chairman and managing partner at Sofinnova Partners. The IPO market has reopened, several large financing deals have closed, and new players have entered the sector.
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