People with obesity now have new tools to help them lose weight, thanks to the US agency’s de novo authorization.
People have new tools to help them lose weight now that the US Food and Drug Administration has given the green light to suturing systems for endoscopic sleeve gastroplasty (ESG) and endoscopic bariatric revision.
The agency granted de novo authorization to Apollo Endosurgery Inc.’s Apollo ESG, Apollo ESG Sx, Apollo REVISE and Apollo REVISE...
The US FDA has issued an early alert to notify consumers about serious risks associated with a recall from Medtronic and its subsidiary Given Imaging. The alert concerns delivery capsules for diagnosing GERD.
SS Innovations reported its first SSi Mantra 3 robotic cardiac surgery in South America as it prepares to file for US FDA de novo clearance and a CE mark. The firm aims to challenge Intuitive Surgical with a lower-cost, flexible system targeting US and European markets.
SS Innovations announced plans to file a de novo application with the US FDA for its SSi Mantra 3 surgical robot, already approved for marketing in six countries. The Florida-based firm also plans to pursue the CE mark for European commercialization.
Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.
Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.
Former HHS-OIG attorney Rob DeConti emphasized the significance of data analytics and compliance in combating healthcare fraud, urging medical tech companies to adopt robust measures to prevent potential risks.
Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.
