The FDA appears poised to impose a tougher clearance process on manufacturers of high-intensity ultrasound systems for prostate tissue ablation. The agency has issued new draft guidance on clinical testing that manufacturers of these devices must conduct, in accordance with special controls. The draft guidance also outlines recommended clinical data to support 510(k) applications for […]
J&J’s Ethicon wins clearance for devices to deliver Grifols surgical sealant
Johnson & Johnson’s Ethicon has won FDA clearance for airless spray devices to deliver Grifols’ fibrin sealant to stop surgical bleeding, the companies announced today. The Vistaseal fibrin sealant will be the first product Grifols (NSDQ:GRFS) is introducing with Johnson & Johnson (NYSE:JNJ) and Ethicon as part of a global partnership. Get the full story on our […]
Materialise wins FDA clearance for 3D modeling software for cardio procedures
Materialise said today that FDA has provided 510(k) clearance for its Mimics Enlight — a cardiovascular procedure planning software creating accurate 3D printed heart models. The Belgian 3D printing software and services company, which has its U.S. offices in Plymouth, Minn., plans the first release of the software to focus on planning for complex transcatheter […]
Ivenix wins 510(k) clearance for infusion system
Ivenix said today that its infusion system won 510(k) clearance from the FDA. The large-volume pump and infusion system features a “smartphone-like” user interface and a suite of administration tools to remotely monitor infusions, according to Ivenix. Get the full story at our sister site, Drug Delivery Business News.
Motus GI lands FDA clearance for next-gen colon prep system
Motus GI (NSDQ:MOTS) today announced it has received FDA 510(k) clearance for the second-generation of its Pure-Vu colonoscopy device. Fort Lauderdale, Fla.-based Motus designed the original Pure-Vu device to attach to standard and slim colonoscopes to deliver a mixture of water and air to remove debris when patients haven’t completed their bowel prep. Pure-Vu GEN2 […]
ReWalk Robotics wins FDA nod for ReStore soft exo-suit
ReWalk Robotics (NSDQ:RWLK) said yesterday that it won FDA 510(k) clearance for its ReStore soft exo-suit system intended for rehabilitation therapy. The Marlborough, Mass.-based company touted the clearance as being the first by the FDA for a soft exo-suit system intended for use in treating stroke survivors with mobility challenges. The ReStore exo-suit features a soft, garment-like […]
Medivis wins FDA nod for augmented reality surgical visualization platform
Surgical visualization tech dev Medivis said yesterday that it won FDA 510(k) clearance for its SurgicalAR augmented reality platform intended for clinical use in the operating room. The New York-based company said that its SurgicalAR platform uses augmented reality, artificial intelligence and computer vision to provide improved surgical visualization in hopes of reducing surgical complications […]
Shape Memory Medical’s embolization plug wins FDA clearance
Shape Memory Medical said today it has received FDA 510(k) clearance for its Impede-FX embolization plug designed to obstruct or reduce the rate of blood flow in the peripheral vasculature. The Impede-FX plug is an adjunct to the Santa Clara, Calif.-based company’s Impede embolization plug, which received 510(k) clearance in 2018. The newly cleared plug […]
Pavmed touts FIH CarpX study launch in pursuit of FDA 510(k) resubmission
Pavmed (NSDQ:PAVM) said yesterday that it launched a first-in-human safety study of its CarpX device to support a planned FDA 510(k) resubmission. The CarpX is a percutaneous device designed to allow the operating physician to relieve compression of the median nerve without a surgical incision. The system combines a balloon catheter with bipolar radio-frequency cutting electrodes […]
MagStim wins FDA nod, launches StimGuide TMS navigation system
Transcranial magnetic stimulation tech dev MagStim said yesterday that it won FDA 510(k) clearance for and launched its StimGuide TMS navigation system, touting it as the first device of its kind. The Eden Prairie, Minn.-based company said that the device is intended for use with its Horizon Performance TMS therapy system. The newly launched device […]
Industry, consumers at odds in push to limit predicate devices in 510(k) pathway
Voices for medical device industry players and consumers clashed in the comments on an FDA proposal announced last November that would limit predicate devices used in 510(k) clearances to those 10 years old or newer. Opinions between the 42 comments left on the proposal were mostly split between industry representatives and consumers, with industry reps […]
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