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 The agency has issued new draft guidance on clinical testing that manufacturers of these devices must conduct, in accordance with special controls. The draft guidance also outlines recommended clinical data to support 510(k) applications for […]
Transplant Biomedicals touts kidney transport device study results
Transplant Biomedicals (Barcelona, Spain) said the first-in-human clinical trial of its kidney transportation device has yielded positive results. The 32-patient study of Vivian Kidney showed an “excellent safety profile” with no device-related adverse events and no organs being discarded before implantation, the company said. The device was also associated with a low rate of delayed […]
AbbVie to buy Allergan for $6.3B
Pharmaceutical giant AbbVie (NYSE:ABBV) said today it will acquire Allergan (NYSE:AGN) for $63 billion in cash and stock. The purchase is seen as a hedge against the impending expiration of U.S. patents on AbbVie’s blockbuster drug, Humira. AbbVie will pay Allergan shareholders $188.24 per share of Allergan stock, a 45% premium to yesterday’s closing price. […]
Heraeus can pursue trade secret suit against Zimmer Biomet supplier
A federal appeals court has resuscitated part of a 2014 Heraeus Medical GmbH lawsuit that accuses Esschem, a chemical supplier to Zimmer Biomet (NYSE:ZBH), of stealing Heraeus’ bone cement recipe. The three-judge panel in Philadelphia said on Friday that Heraeus can pursue claims stemming from Esschem’s alleged use of Heraeus’ information within three years before […]
CMS expands TAVR coverage
The Centers for Medicare and Medicaid Services have updated the criteria for hospitals and physicians to begin or continue providing transcatheter aortic valve replacement surgery. The decision gives hospitals and providers more flexibility to meet the CMS requirements for performing TAVR, the agency said Friday. The original National Coverage Determination (NCD) for TAVR procedures was cleared in […]
8 medical device industry supplier innovations you need to know
Medical device innovation doesn’t just come from startups or big corporate R&D departments. Contract manufacturers and suppliers are increasingly playing a role, too. [Image by Kristopher Roller on Unsplash] Long gone are the days when medical device industry suppliers simply produced or manufactured according to specifications. Companies are increasingly coming up with their own answers […]
Two deaths reported in recall of 6 million Teleflex endotracheal tubes
Teleflex (NYSE:TFX) is recalling multiple models of its Hudson RCI Sheridan and Sheridan endotracheal tubes due to complaints of the Sheridan connector disconnecting from the breathing circuit. Two deaths and one injury have been reported to the company, according to the FDA. Each of the more than 6 million recalled tracheal tubes includes an appropriately sized […]
Ocular Therapeutix gains second indication for drug-delivery eye insert
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA has approved a supplemental NDA for its dexamethasone ocular insert, Dextenza. The Bedford, Mass.-based company requested in January that the U.S. regulatory agency expand the current indication for Dextenza to include the treatment of ocular inflammation following eye surgery. Dextenza is designed to deliver drugs for up to 30 days […]
First patients implanted with Exactech’s non-cemented Truliant knee
Exactech (NSDQ:EXAC) today announced the successful first surgeries involving its Truliant Porous knee implant. Truliant Porous is a non-cemented implant system that Exactech said is designed for reproducibility and efficiency in total knee arthroplasty. Truliant Porous is designed to reduce micromotion and aid potential bony in-growth, according to the company. The system features a unique […]
PrinterPrezz gains QMS certification for medical devices
Metal 3D printing company PrinterPrezz (Fremont, Calif.) today announced it has achieved ISO 13485:2016 certification for Quality Management Systems for medical devices. ISO 13485:2016 certification is a requirement for regulatory purposes and is an international standard that outlines the requirements for a quality management system specific to the medical devices industry. To be certified, organizations must demonstrate […]
BD sues NeuMoDx over patents for diagnostic device
Becton Dickinson (NYSE:BDX) and subsidiaries HandyLab and GeneOhm Sciences Canada have filed a lawsuit against diagnostics company NeuMoDx, claiming patent infringement. BD acquired small diagnostics company HandyLab (Ann Arbor, Mich.) in 2009 for $275 million. HandyLab was developing bench-top devices for fast and early detection of diseases, according to the complaint, filed in U.S. District […]
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