Regulatory Approvals

FDA clears IceCure Medical’s next-gen single-probe cryoablation system

IceCure Medical announced the FDA granted clearance for its next-generation single-probe cryoablation system. The XSense cryoablation system with CryoProbes received clearance for all indications...

CeQur wins FDA nod for mealtime insulin delivery device

CeQur announced recently that the FDA granted 510(k) clearance for its Simplicity system for an extended wear duration. Clearance extends the wear time for...

FDA expands Fractyl endoscopy trial to include untreated diabetes patients

The US FDA has given the green light for metabolic therapeutics company, Fractyl Health, to expand the  REVITALIZE-1 clinical study for  its endoscopic device...

FDA approves Endotronix Cordella PA sensor system for heart failure treatment

Endotronix today announced it received FDA premarket approval for its Cordella PA Sensor System. The Naperville, Illinois=based company designed the Cordella Pulmonary Artery (PA)...

Nexalin wins US patent for Alzheimer’s deep-brain stimulation device

Nexalin Technology has secured a US patent for its non-invasive, frequency-based, deep-brain stimulation device aimed at treating Alzheimer’s and dementia. The US Patent and Trademark...

Elixir Medical wins FDA breakthrough nod for sirolimus-eluting bioadaptor system

Elixir Medical received FDA breakthrough device designation for its DynamX bioadaptive implant. The breakthrough nod covers the improvement of coronary luminal diameter, restoration of...

AtHeart Medical reports positive data for ASD occluder with bioresorbable frame

AtHeart Medical today announced positive long- and short-term clinical outcomes for its reSept atrial septal defect (ASD) occluder.Data from three patient cohorts showed positive...

CardioFlow wins CE mark for VitaFlow Liberty TAVI system

MicroPort CardioFlow Medtech Corp. today announced that it received CE mark for its second-generation aortic valve implant.The VitaFlow Liberty transcatheter aortic valve implant (TAVI)...

Xeltis wins FDA IDE approval for restorative vascular access conduit pivotal trial

Xeltis announced it received FDA investigational device exemption (IDE) to begin a pivotal study of its restorative vascular access conduit. aXess enables the creation...
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