
Astellas subsidiary Iota wins FDA IDE nod to study implantable bladder device
Iota Biosciences, a subsidiary of Astellas Pharma, announced that it received FDA investigational device exemption (IDE) for its bladder implant.
Iota Biosciences, a subsidiary of Astellas Pharma, announced that it received FDA investigational device exemption (IDE) for its bladder implant.
Endostart announced today that it received CE mark approval for the expanded use of its flagship Endorail product.
Johnson & Johnson MedTech (NYSE: JNJ)+
announced today that it launched its VOLT (variable angle optimized locking technology) plating system.
Si-Bone today announced the first patient procedures with its FDA breakthrough device, the iFuse Torq TNT implant system.
Biodegradable structures could revolutionize energy, information technologies and advanced medicine
AccurKardia announced that it received FDA breakthrough device designation for its aortic valve stenosis (AVS) ECG-based AI screening software.
Regenity Biosciences announced that it received FDA 510(k) clearance for its RejuvaKnee implant for soft tissue injuries of the meniscus.
Medinol today announced the successful first-in-human implantation of its ChampioNIR drug-eluting peripheral stent.
Procept BioRobotics (Nasdaq:PRCT) announced today that the FDA approved an investigational device exemption (IDE) trial for its Aquablation therapy.
CHICAGO, Oct. 3, 2024 /PRNewswire/ — Amphix Bio, a company developing a new class of regenerative medicine therapies, announced today it has received a Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for a drug-device combination product for bone regeneration. The designation covers the use of the therapeutic device to treat degenerative disc disease with transforaminal lumbar interbody fusion (TLIF) procedures.