By Stewart Eisenhart, Emergo Group New draft guidance from the US Food and Drug Administration seeks comment on how to effectively apply requirements that Unique Device Identification data be applied directly to medical devices intended for reprocessing and reuse. The agency’s guidance points out that its UDI rule, 21 CFR 801.25, explicitly requires directing UDI marking on […]
FDA
Teleflex recalls neonate manual resuscitator
Teleflex (NYSE:TFX) said yesterday it is recalling its Hudson RCI Lifesaver neonate manual resuscitator. The company said it began notifying hospitals and distributors of the recall on May 14. The FDA labeled it a Class I recall, the most serious type of recall issued by the federal watchdog, indicating that “there is a reasonable probability that use of these […]
Hong Kong regulators issue list of recognized standards for medical devices
By Stewart Eisenhart, Emergo Group Regulators in Hong Kong have published a new list of recognized standards applicable to medical devices as the region moves toward more formal oversight of its device market.
Ex-OtisMed CEO Chi draws 2 years
The former CEO of Stryker (NYSE:SYK) subsidiary OtisMed, Charlie Chi, drew a 2-year prison sentence last week after pleading guilty to distributing knee replacement surgery cutting guides without FDA clearance, the safety bureau and federal prosecutors said last week. Stryker inherited the beef when it acquired OtisMed in 2009, later offering to pay $33 million to settle the […]
Caldera Medical wins FDA 510(k) for next-gen Vertessa Lite mesh
Caldera Medical said today it won FDA 510(k) clearance for its next-generation Vertessa Lite polypropylene mesh for treating pelvic organ prolapse. The new version of the mesh is lighter, 31% stronger than other market-leading meshes and has a 32% increased suture pull out strength, the Agoura Hills, Calif.-based company said. “As part of our continuous […]
Exactech wins FDA 510(k) for Optetrak knee prosthesis
Exactech (NSDQ:EXAC) said yesterday that it won FDA 510(k) clearance for its Optetrak Logic constrained condylar prosthesis for revision knee arthroplasty patients. The knee prosthesis is approved for indications in patients undergoing total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, post-traumatic degenerative problems and to replace failed knee devices, the Gainesville, Fla-based company said. […]
Medtronic wins FDA nod, launches Advisa SR MRI-safe pacer
Medtronic (NYSE:MDT) said today that it won FDA approval for its Advisa SR MRI-safe SureScan single-chamber pacemaker, and that it is launching the device in the U.S. The device will allow MRI scans of any region of the body as long as it is used with MRI-safe SureScan leads, the Fridley, Minn.-based company said. “MRI is […]
FDA panel to discuss safety of Bayer’s contraceptive device Essure
(Reuters) — The U.S. Food and Drug Administration said it would discuss the safety and effectiveness of Bayer (ETR:BAYN) AG’s controversial contraceptive device, Essure, in a public panel meeting after receiving more than 5000 complaints, including those of deaths and pregnancies. Essure, which is the only approved permanent birth control device in the United States, is […]
Emergo Podcast: ANVISA medical device approval in Brazil
By Stewart Eisenhart, Emergo Group Brazil’s medical device market offers significant growth potential for foreign manufacturers, but the country’s device approval process is challenging. In this podcast, Emergo Vice President of Business Development Ann Marie Boullie provides an overview of Brazil’s regulatory requirements for medical device registration, including:
AxoGen enrolls first subject in nerve graft study
AxoGen Inc. (NSDQ:AXGN) said yesterday that it enrolled the 1st subject in a clinical trial of its Avance nerve graft. The multicenter, prospective randomized Recon study will compare the Avance graft to nerve tubes currently used for bridging peripheral nerve tissue gaps, the Florida-based regenerative medicine company said. The data from the Recon trial will […]
New US FDA guidance: Six benefit-risk factors to include in medical device IDE applications
By Stewart Eisenhart, Emergo Group In an effort to boost predictability and transparency of its Investigational Device Exemption (IDE) review process, the US Food and Drug Administration has published new guidance explaining key issues the agency uses to assess benefits and risks of IDE submissions for clinical investigations of Class III and some Class II […]