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...
Announced in conjunction with a $97m Series D financing round, Neptune underscores its gastrointestinal focus and robotics aspirations by spinning out Jupiter Endovascular, which will leverage $21m of the funding to support ongoing development of its Endoportal Control technology.
A survey of over 1,000 patients worldwide found that the majority of patients agree that hospitals and endoscopists are responsible for mistakes made by devices that use AI.
In 2024, Visana Health will leverage $10.1m in seed funding to expand its holistic, value-based virtual clinic to add conditions that differently or disproportionally affect women and provide at-home testing. Health plans and employers are taking notice, and Visana’s CEO expects further investment to follow.
Olympus Medical has issued a recall of its High-Flow Insufflation Unit after reports of cardiac events during surgical procedures performed while using the device. The company has also requested providers stop using the device unless no alternative is available.
Biopharmaceutical giant AstraZeneca has partnered with start-up “unicorn” Owkin to develop an AI-powered tool to prescreen for gBRCA mutations on the basis of morphological features in digitized pathology slides. Built on extensive, high-quality data sourced from the France-based PortrAIt consortium, the AI will help to prioritize patients for further testing, streamlining the diagnostic process, Owkin says.
An additional $50m brings the neurovascular intervention specialist’s total Series F funding to $82m. Route 92 says it will use the capital to build its sales and support teams and pursue regulatory authorizations around the globe for its FreeClimb portfolio while advancing its SUMMIT MAX clinical trial for the investigational Monopoint Reperfusion System.
TRiCares announced first implantation of the Topaz transfemoral tricuspid heart valve replacement system as part of the company’s EU pivotal study. If all goes to plan, the device will compete with Edwards’ Evoque system. The announcement follows the company’s $50m series D funding raise in July.
