This article has been updated with a statement from Innovative Sterilization Technologies. The FDA has issued a warning letter to Innovative Sterilization Technologies, claiming that the Dayton, Ohio-based company has been marketing its surgical device sterilization trays for non-cleared purposes. Innovative Sterilization Technologies makes the One Tray reusable sealed sterilization container intended to hold reusable medical […]
Boeing’s 737 Max crisis: Why the medical device industry should care
Let’s just say that airplane and medical device manufacturers have “substantially equivalent” problems. The crisis over the 737 Max tells us why. Ashley Holub (Twitter @ashtroid22) From Netflix’s documentary “The Bleeding Edge” to the International Consortium of Investigative Journalists’ “The Implant Files” series, FDA has taken heat over the 510(k),which allows devices with “substantially equivalent” features to previously […]
Most FDA device fees up nearly 6% for FY2020
The FDA today set the user fee rates for fiscal 2020, which is slated to begin in October, raising all but one of the fees across the board by nearly 6%. Medical device makers pay user fees to have the FDA review their products. The rates rose by nearly 4% for fiscal 2019. The agency […]
Boston Scientific launches Tactra penile implant
Boston Scientific (NYSE:BSX) recently launched what it describes as a durable, natural-feeling implant to treat erectile dysfunction. A man with the Tactra implant in his member can push it up for intercourse and manually pushed it down when it is not in use. The prosthesis is made of dual-layer silicone in order to give it a […]
AirXpanders wins FDA clearance for smooth AeroForm
AirXpanders said today that it has received FDA clearance to market a smooth shell version of its AeroForm Tissue Expander. The Palo Alto, Calif.–based company makes the AeroForm device for post-mastectomy breast reconstruction. It is designed to expand and stretch the skin and underlying muscle prior to a permanent breast implant using small amounts of […]
FDA clears RaySearch’s RayStation 8B
RaySearch yesterday announced it received FDA 510(k) clearance for its RayStation 8B treatment planning system. The RayStation 8B is a machine learning treatment planning system for the radiation oncology market. The system uses deep neural networks and is designed for automated treatment planning and automated organ segmentation to improve efficiency and consistency. The framework of […]
FDA wants tighter control of certain prostate ablation devices
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 […]
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