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Johnson & Johnson has announced that the FDA has granted De Novo authorisation for its OTTAVA Robotic Surgical System, the world’s first table-integrated soft tissue robotic system. The system received marketing authorisation for multiple procedures in general surgery, including Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication and hiatal hernia repair. Johnson & Johnson

The FDA has approved Eli Lilly and Company’s Foundayo (orforglipron) for adults with obesity or overweight with weight-related medical problems. Foundayo is a once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist (GLP-1ra) that can be taken any time of the day without restrictions on food and water intake. "People living with obesity need treatment options that meet them where they are – and for many, a once-daily pill that can be taken with n

The FDA has approved the premarket approval (PMA) application for the Allurion Gastric Balloon System (AGBS), featuring the Allurion Smart Capsule. The Allurion Program is a weight-loss platform that combines the FDA PMA approved Allurion Gastric Balloon System, featuring the Allurion Smart Capsule, with the Allurion Virtual Care Suite, including the Allurion Mobile App for consumers featuring the Iris AI platform, Allurion Insights for healthcare providers, and the Allurion

The FDA has approved Novo Nordisk’s once-daily Wegovy pill, the first oral GLP-1 medicine for obesity in the US. The Wegovy pill can be used with a reduced calorie diet and increased physical activity for adults with obesity, or with overweight who also have weight-related medical problems, to help them lose weight and keep it off. The pill is also indicated to reduce the risk of major adverse cardiovascular events (MACE) such as death, heart attack, or stroke in adults with

Novo Nordisk has received FDA approval for Rybelsus for reducing the risk of major adverse cardiovascular events (MACE) such as cardiovascular (CV) death, heart attack, or stroke in adults with type 2 diabetes who are at high risk for these events, whether they've had a prior CV event or not (primary and secondary prevention). Results of the SOUL trial reinforce the clinical profile of the semaglutide molecule, which has been studied across a variety of therapeutic areas. "Ev

The FDA has approved Eli Lilly and Company's Zepbound (tirzepatide) injection, the first and only obesity treatment of its kind that...

Apollo Endosurgery has been granted marketing authorisation for its ESG, ESG Sx, REVISE and REVISE Sx through the FDA’s De Novo...