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FDA approves Soleno’s VYKAT XR to treat hyperphagia in Prader-Willi Syndrome
The FDA has approved Soleno Therapeutics’ VYKAT XR (diazoxide choline) extended-release tablets, previously referred to as DCCR, for the...
GT Metabolic expands MagDI System with FDA clearance of 50mm magnet
The FDA has cleared GT Metabolic Solutions’ larger, 50mm MagDISystem magnet to complement the system's existing 40mm magnet. This...
Zepbound (tirzepatide) is the first and only FDA approved prescription medicine for moderate-to-severe OSA in adults with obesity
The FDA has approved Eli Lilly and Company’s Zepbound (tirzepatide) as the first and only prescription medicine for adults with...
GT Metabolic's MagDI System for side-to-side DI anastomosis to "revolutionise industry" after FDA approval
GT Metabolic Solutions has received FDA clearance of its MagDI System for side-to-side duodeno-ileal (DI) anastomosis. The MagDI System...
FDA grants De Novo approval for Distalmotion’s Dexter Surgical Robot for adult inguinal hernia repair
Distalmotion has been granted De Novo approval by the FDA to market the Dexter Surgical Robot for adult inguinal hernia repair. This...
FDA approves Epitomee Capsule for weight management
Epitomee Medical has gained FDA clearance for its Epitomee Capsule, an ingestible medical device designed to support weight management in...
Lilly receives UK marketing authorisation for tirzepatide (Mounjaro) in alternative Kwikpen presentation for two indications
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Eli Lilly’s tirzepatide...
FDA approves ReShape Lifesciences’ next-generation Lap-Band 2.0 FLEX
The FDA has granted approval of a PMA supplement for ReShape Lifesciences’ next generation, enhanced Lap-Band 2.0 FLEX. According to the...
Lilly's Mounjaro (tirzepatide) receives UK marketing authorisation for weight management
Eli Lilly and Company has granted marketing authorisation (MA) by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for...
FDA clears GE HealthCare’s Allia IGS Pulse next generation of image-guided systems
GE HealthCare has gained FDA 510(k) clearance of the Allia IGS Pulse - the latest addition to the company’s image guided system (IGS)...
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