Nelson Labs parent Sterigenics buys Toxikon’s European lab business

Sterigentics International is seeking to turn its Nelson Labs business into a global extractables and leachables lab testing platform through its acquisition of Toxikon’s European division. The purchase of Toxikon Europe, announced yesterday, represents a capabilities expansion when it comes to serving the pharmaceutical and medical device industries. Sterigenics’s Nelson Labs business will now offer Toxikon

Europe’s new plan to address orphaned medical device manufacturers

By Annette van Raamsdonk, Emergo Group European Member States are implementing a procedure for manufacturers that no longer have a Notified Body (NB) due to scope reduction or de-notification. 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

Validation and testing: What you need to know

James Woods, Jordi Labs In an increasingly competitive medical device industry, it’s still important that validation and testing is done right. Here are four things to keep in mind. Medical device industry leaders these days are driving results at an ever-increasing pace. Amid patent limitations, intense competition and acute regulatory scrutiny, there’s a rush to

FDA launches new market pathway for breakthrough medical devices

By Stewart Eisenhart, Emergo Group The US Food and Drug Administration plans to establish a new market authorization pathway for innovative and breakthrough medical devices that would replace current priority review programs including the Expedited Access Pathway (EAP) and the Priority Review Program. Get the full story here at the Emergo Group’s blog. The opinions

Medtech stories we missed this week: Oct. 27, 2017

From RadiaDyne’s FDA expansion to NuVasive launching its new implants, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA expands indications for RadiaDyne’s OARtrac dose monitor RadiaDyne announced in an Oct. 24 press release that it has received additional FDA clearance for its upcoming OARtrac. The OARtrac allows

Navigating the FDA for connected devices

As connectivity features become increasingly prevalent, developers are tasked with accounting for regulatory implications in increasingly long-term plans. Aidan Petrie, Ximedica Let’s imagine a product that dispenses a drug for eczema. At its most basic, the dispenser is little more than a package for the primary drug container and so falls under some medical packaging

Medtech stories we missed this week: Oct. 20, 2017

From InspireMD’s distribution deal to RenalGuard touting a new study, here are seven medtech stories we missed this week but thought were still worth a mention. 1. InspireMD inks Chile distribution deal InspireMD announced in an Oct. 12 press release that it has signed a distribution deal with CorpMedical Chile to distribute the MGuard Prime

OptiScan’s glucose monitoring system for the ICU wins 510(k) clearance

OptiScan Biomedical said today that its OptiScanner 5000 glucose monitoring system won 510(k) clearance. The device is the first-of-its-kind, providing physicians with trending and tracking information to manage their patients’ blood glucose levels in surgical intensive care units. Get the full story at our sister site, Drug Delivery Business News.

Medtech stories we missed this week: Oct. 13, 2017

From Orthocell’s distribution deal to CorNeat unveiling its artificial cornea, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. OrthoCell inks Australian distro deal Orthocell announced in an Oct. 10 press release that it has signed a distribution deal with Surgical Specialities. The deal will make Surgical Specialities the

Australian TGA updates medical device recall process in early 2018

By Stewart Eisenhart, Emergo Group Australian medical device regulators will implement changes to their recall requirements for medical devices and other healthcare products in January 2018. 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

Autocam Medical facility certified to ISO 13485:2016

Autocam Medical (Kentwood, Mich.) announced that its Plymouth, Mass. facility was recently certified to ISO 13485:2016. The surgical implants, instruments and related products manufacturer showed that its quality system was effectively implemented and maintained in order to be ISO 13485 certified. “This recertification indicates our continued investment in a quality management system which ensures process control, accurate

NSF International acquires Prosystem

NSF International recently acquired German medical device consulting firm Prosystem AG, expanding its medical device consulting services into Europe. The company’s acquisition helps expand medical device business into Europe and allows NSF International to meet an increasing demand for medical device consulting, education and training services in Europe. It also allows NSF International’s customers to

Medtech stories we missed this week: Oct. 6, 2017

From Intellijoint’s CE Mark to Patrona Medical and Kopis’ new partnership, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Intellijoint CE Mark for flagship hip navigation Intellijoint surgical announced in an Oct. 4 press release that it has received CE Mark for its Intellijoint HIP System in

Who got picked for FDA’s digital health pre-cert pilot?

FDA has announced the names of the companies selected to participate in its digital health pre-cert pilot – a first-of-its-kind program aimed to revolutionize digital health regulation in the U.S. Dr. Scott Gottlieb, FDA’s commissioner, announced the nine participants of FDA’s digital health software precertification pilot program (FDA Pre-cert) last week during his keynote address at the

7 breast cancer breakthroughs you need to know

As we mark another Breast Cancer Awareness Month, it’s worth noting the recent strides that have been made when it comes to diagnosing and treating the disease. Breast cancer is the most common form of cancer in women in the U.S. Affecting one in eight women, breast cancer will be accountable for about 40,610 deaths

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