NxStage Medical’s Todd Snell talks FDA, Brexit & regulatory strategy

Between the consequences of Brexit and a new commissioner at the FDA, executives across medtech are bracing for change within the global regulatory landscape. NxStage Medical‘s (NSDQ:NXTM) SVP of quality assurance, regulatory & clinical affairs, Todd Snell, spoke with MassDevice.com editor Sarah Faulkner about what he’s observing from his post at the Lawrence, Mass.-based company. Faulkner: What has

The U.K. wants to speed up medtech approvals: Here’s how

The U.K. is in the midst of changes to the appraisal pathways for assessing and funding health technologies, according to RTI-HS staff attending the recent  National Institute for Health and Care Excellence (NICE) 2017 conference. Caroline Ling and Jessica Costello, RTI-HS We and other RTI-HS staff recently attended the National Institute for Health and Care Excellence (NICE) 2017

Could this new assay reduce the need for animal tests?

American Preclinical Services has developed a novel assay that its creators think could replace the thromboresistance animal tests for medical devices – which use dogs, sheep and pigs. Mark E. Smith, American Preclinical Services Blood-contacting medical devices and the materials from which they are constructed must meet stringent safety criteria prior to regulatory approval for

What FDA medical device user fee reauthorization means for registrants

By Stewart Eisenhart, Emergo Group After two years of negotiations, the U.S. government has enacted the FDA Reauthorization Act of 2017, or FDARA, that enables the agency to continue using medical device, drug and other health product user fees as a key source of funding through 2022. Get the full story here at the Emergo

FDA adds UL2900 standard for medical device cybersecurity

By Stewart Eisenhart, Emergo Group US medical device regulators have officially included a new cybersecurity standard from UL to their list of recognized standards for use in premarket reviews. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect

How FDARA is making a difference for industry and patients

Drs. Peter Marks, Jeffrey Shuren, and Janet Woodcock, FDA For decades, user fees paid by the medical products industry have provided critical resources needed to conduct product reviews in a timely fashion and to help ensure the safety and effectiveness of medical products that American patients depend upon. Since passage of the first medical product

UDI laser marking: Here’s the key to making it durable

Optimized lasers and passivation can make the difference when it comes to creating durable UDI laser markings for medical devices, according to a new long-term case study. Tuttlingen, Germany–based Add’n Solutions, worked with FOBA Laser Marking+Engraving to test the marking processes. The results found that FOBA’s short pulse fiber making lasers worked better when optimized to adapt to

FDA pre-certification for software program: key questions and eligibility requirements

Stewart Eisenhart, Emergo Group Following the rollout of a pre-certification pilot program for digital health technology and software developers, the U.S. Food and Drug Administration has identified and answered several frequently asked questions regarding participation. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s

FDA approves pivotal study of Vascular Dynamics MobiusHD high blood pressure device

Vascular Dynamics said today that the FDA approved an investigational device exemption for a clinical trial of its MobiusHD device for treating resistant hypertension. MobiusHD is designed to help regulate blood pressure using electrodes implanted in the carotid artery to stimulate baroreceptors there. Mountain View, Calif.–based Vascular Dynamics said the 300-patient Calm 2 study is designed

Medical device regulation: How it’s changing in the U.S. and Europe

Mary Beth Ritchey, RTI Health Solutions This is a busy year for medical device regulation in the United States and Europe. U.S. medical device regulation legislation In the U.S., the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) is due to expire Sept. 30. A new bill including updates for medical devices has

Medtech stories we missed this week: August 11, 2017

From Xtant Medical’s 510(k) extension to Varian Medical’s distribution deal, here are seven medtech stories we missed this week but thought were still worth a mention. 1. FDA extends Xtant Medical’s 510(k) for Calix C spinal implant Xtant Medical announced in an Aug. 9 press release that the FDA has cleared its product line extensions

Validation: 8 things you need to know

Validation of manufacturing processes is extremely important, given our highly regulated environment. Here’s a primer to get you started on the subject. Steve VanderKooi, Kyle Kulwicki, Kevin Roberts, PTI Engineered Plastics Validation uses objective evidence to prove that a process is capable of consistently producing a product that meets pre-defined requirements, including customer and user needs, functional

Serious medical device recalls nearly doubled in Q2

Medical device recalls at the Class I level were up 88% during the second quarter of 2017, and the major culprit was quality issues involving device part malfunctioning, according to a new report from Stericycle ExpertSolutions. Quality played a significant role among the 15 serious medical device recalls during the second quarter, partly because it encompasses such

FDA unveils digital health technology changes

By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) have published further details on their plans to clarify and improve policies regarding mobile medical applications, wearables and other digital health products. Get the full story here at the Emergo Group’s blog. The

Chinese regulators answer two common clinical trial questions

By Stewart Eisenhart, Emergo Group China Food and Drug Administration (CFDA) regulators have addressed frequently asked questions regarding clinical trial requirements for medical devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its