Seisa Medical closes $42.5 million recapitalization and acquisition line

Seisa Medical (El Paso, Texas) announced that it has closed a $42.5 million senior secured credit facility with Sagard Credit Partners. Most of the funds from the deal will be used to be fees and expenses from the transaction while administering a dividend to shareholding and completing acquisitions. “We are excited to begin this relationship

MD&M West 2018: Medtech supplier innovations you need to know

Updated Feb. 5 More than 20,000 engineers and executives are expected to gather and network for the annual MD&M West – one of the largest annual medical device manufacturing events. The event takes place at the Anaheim Convention Center in Anaheim, Calif., Feb. 6–8, and houses an array of industry suppliers showcasing their latest technologies and manufacturing advancements. Think medical

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Heraeus opens new Costa Rica manufacturing facility

Heraeus Medical Components announced that it has recently opened its new manufacturing facility in Costa Rica where the company is expected to produce more than two million guidewires this year. The new facility, located in Cartago, Costa Rica, was designed to supply local and U.S.-based medical device companies with advanced component and sub-assembly solutions. The

EU gives Brexit notice to economic operators and impact for medical device industry

By Ronald Boumans and Annette van Raamsdonk, Emergo Group A new notice from the European Commission lays out how Brexit will impact economic operators including medical device companies, Authorized Representatives and Notified Bodies. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and

This remote-controlled immunotherapy system targets and kills cancer cells

University of California researchers have developed a remote-controlled therapy system that identifies and kills cancer cells using ultrasound. The ultrasound-based system is able to non-invasively and remotely control the genetic process in immune T cells to identify and kill cancer cells. According to the researchers, the ability to non-invasively and remotely manipulate cells at a

NAMSA expands medical device testing services

NAMSA (Toledo, Ohio) recently announced that it has launched its Analytical Services Laboratory in Obernburg, Germany to further expand access to accelerated product development and testing services. The company’s new facility offers European device manufacturers a facility that meets ISO 10993-18 testing requirements. It will also offer exhaustive extraction, FTIR, GC-MS, LC-MS and ICP-MS services in

Eudamed development on schedule

By Ronald Boumans, Emergo Group European regulators appear on track to launch the Eudamed database for medical devices in March 2020, but stakeholder accessibility may take longer than that. 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

Charting the FDA’s course for 2018-2020

By: Jeff Shuren, M.D., J.D. Since 2012, we at the Center for Devices and Radiological Health have set as our North Star the vision of patients in the U.S. having access to high-quality, safe, and effective medical devices of public health importance first in the world. “First in the world” is not about a competition

Agilent inks incubator deal with USC

Agilent Technologies announced that it has formed a scientific collaboration with the University of Southern California Michelson Center for Convergent Bioscience. The collaboration will help create an Agilent Center of Excellence in Biomolecular Characterization. The new center will be located in Michelson Hall at USC. The research facility will help establish a convergence of researchers

Freudenberg Medical expands micro injection molding and opens Singapore office

Freudenberg Medical recently announced that it has expanded its thermoplastic micro injection molding capabilities by adding an ARBURG micro injection modular machine. The company added the new machine to meet challenging molding requirements. “Engineering grade materials can be sensitive to shear and a very fine level of control is needed to produce shot weights under

FDA delays contentious medical device intended use rule

By Stewart Eisenhart, Emergo Group US medical device regulators at the Food and Drug Administration has indefinitely delayed implementation of part of a final rule covering intended use determinations by the agency following industry questions and concerns. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are

Crystal IS UVC LEDs compliant with ISO 10993-5 Cytotoxicity

Crystal IS recently announced that its Klaran HC UVC LEDs are the first high performance UVC LEDs to be ISO 10993-5 Cytotoxicity compliant. The company’s Klaran HC products have previously been tested and proved to be biocompatible to be used in Class I and Class II medical devices that need an FDA 510(k) submittal. Crystal

FDA announces deadline for UDI compliance for low-risk medical devices

By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has formally pushed back some Unique Device Identification (UDI) compliance deadlines by two years for qualifying low-risk 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

Medtech stories we missed this week: Jan. 26, 2018

From Attune Medical receiving FDA 510(k) clearance to Synapse Medical having CE Mark approval, here are some medtech stories we missed this week but thought were still worth mentioning. 1. Attune Medical gets FDA 510(k) clearance Attune Medical announced in a Jan. 8 press releasethat it has received FDA 510(k) clearance for its EnsoETM model

3M submits 510(k) for steam sterilization system

3M has submitted an application to receive FDA 510(k) clearance for its Attest Super Rapid System for steam sterilization. The steam sterilization system can provide biological indicator results in 24 minutes. A faster readout time for steam will help improve patient safety while increasing workflow for sterilization professionals. “The focus of our sterilization science at