Tag: telehealth

The medical technology sector witnessed a significant shift last week as Johnson & Johnson announced that its Ottava surgical robotic system has received de novo authorization from the U.S. Food and Drug Administration. This regulatory milestone, which arrived earlier than many industry analysts had projected, positions the healthcare giant to directly challenge the long-standing dominance…

The Federal Trade Commission has filed a comprehensive lawsuit against Hims & Hers Health, Inc., alleging that the telehealth giant compromised the sensitive medical information of millions of users and employed deceptive "dark patterns" to lock consumers into recurring subscriptions. The legal action, filed in a California federal court, marks a significant escalation in the…

Abbott Laboratories has officially initiated a large-scale, real-world clinical study to evaluate the long-term safety and performance of its TriClip transcatheter edge-to-edge repair (TEER) system. This strategic move comes as the medical device giant seeks to solidify its dominant position in the rapidly expanding structural heart market, specifically targeting tricuspid regurgitation (TR), a condition long…

Boston Scientific Corporation announced a significant downward revision to its full-year 2026 financial outlook on Wednesday, marking the second consecutive quarter the medical device giant has lowered its projections. The adjustment comes as two of the company’s primary growth engines—its Watchman left atrial appendage closure (LAAC) franchise and its electrophysiology (EP) portfolio—face a combination of…

Royal Philips has reported a substantial surge in net income for the second quarter of 2026, a result largely driven by the successful recoupment of hundreds of millions of euros in previously paid U.S. tariffs. According to the latest financial disclosures, the Dutch health technology giant recorded a net income of 386 million euros, representing…

Boston Scientific, a preeminent leader in the global medical technology sector, has officially announced the commencement of a comprehensive multi-year restructuring program designed to streamline its operational framework and bolster its long-term strategic priorities. The initiative, revealed ahead of the company’s highly anticipated quarterly earnings report, seeks to address evolving market dynamics in the cardiovascular…

The United States Food and Drug Administration (FDA) has officially granted a breakthrough device designation to Aidoc, a leading provider of clinical artificial intelligence, for its pioneering "First Read" technology. This decision marks a significant milestone in the integration of generative artificial intelligence (AI) within the medical imaging sector, specifically targeting the interpretation and reporting…

The U.S. Food and Drug Administration has granted formal approval to Freenome’s SimpleScreen, a non-invasive blood-based screening test designed to detect colorectal cancer in adults aged 45 and older who are at average risk for the disease. This regulatory milestone has immediately triggered a $100 million payment to Freenome from its commercial partner, Abbott, under…

The U.S. Food and Drug Administration (FDA) has categorized the recent recall of the Enroute Transcarotid Neuroprotection System (NPS), manufactured by Silk Road Medical and recently acquired by Boston Scientific, as a Class I recall, the most serious level of regulatory action. This designation indicates that the use of the affected devices could result in…

Edwards Lifesciences, a global leader in patient-focused medical innovations for structural heart disease and critical care monitoring, reported second-quarter financial results that exceeded internal projections and bolstered investor confidence in the long-term viability of the transcatheter heart valve market. The California-based medical technology giant announced total sales of $1.74 billion for the period ending June…