MDIC to Hold Annual Public Forum
The Medical Device Innovation Consortium is inviting stakeholders to join industry peers in learning about recent activities by the public-private partnership, which focuses on medical device regulatory science. Scheduled for Sept. 25 in Washington, D.C., the event will examine, among other topics, the FDA’s regulatory science priorities. It will feature a talk by CDRH Director Jeff Shuren, as well as former Medtronic CEO Bill Hawkins, who now is the lead director at Immucor. Register to attend in person or by webcast at .
Roche to Buy GeneWEAVE BioSciences
Swiss healthcare giant Roche has inked a definitive agreement to acquire GeneWEAVE BioSciences for $190 million upfront and up to $235 million more if certain milestones are met. The deal gives Roche access to GeneWEAVE’s Smarticles technology, designed to identify multidrug-resistant organisms and assess their antibiotic susceptibility directly from clinical samples. An initial product, the vivoDx, is being evaluated in a multicenter clinical trial in the U.S. GeneWEAVE will be integrated into Roche Molecular Diagnostics upon the deal’s close.
Action Taken Against Infusion Product
Brazil’s Agência Nacional de Vigilância Sanitária has asked Descarpack of Brazil Ltd. to suspend marketing and distribution of Equipo Macrogotas for intravenous infusion, lot SEML 024-SET / 2013, with an August 2018 expiration date. The product — used to infuse sterile parenteral solutions — yielded unsatisfactory results in tests by the Adolfo Lutz Institute. ANVISA has advised the company to take back unused products in this lot from customers in the state of São Paulo.
CareFusion Recalls 7,000 Alaris Pumps
CareFusion is promising to take corrective action in the wake of recalling 7,481 units of its Alaris Syringe pump. The FDA has deemed it a Class I recall, saying in a notice that “the channel error will cause an audible and visual alarm on the Alaris PC unit and a channel error on the Alaris Syringe.” The recall covers model 8110, which was manufactured between March and September 2014. The model was distributed in Australia, New Zealand, South Africa, Canada, the Middle East, Malaysia and Taiwan. This marks CareFusion’s ninth Class I recall of an Alaris device since 2010.
Regulatory Bodies Warn on Rib Supports
Johnson & Johnson has alerted health authorities around the world about a design issue with its Vertical Expandable Prosthetic Titanium Rib (VEPTR) caudal rib supports that could lead to potential adverse events in patients with thoracic insufficiency syndrome. J&J subsidiaries are recalling unused stock as a result of a partially formed hole in the supports that could lead to mechanical failure if the system is fully lengthened. There are no confirmed reports of breakage directly related to the partially formed holes. However, there have been eight cases of extension bar breakage when the VEPTR system was fully extended since 2004.