GVS buys Kuss Filtration

Microfiltration company GVS announced today that it has entered an agreement to acquire Kuss Filtration from Industrial Opportunity Partners. The financial details of the deal were not disclosed. Under the terms of the acquisition, GVS and Kuss will work together to enter the micro filtration and automotive markets. “GVS has high expectations for this new

Medical device R&D investments expected to rise through 2018

By Stewart Eisenhart, Emergo Group An Emergo survey of medical device companies finds that a higher percentage of smaller firms plan to increase their research and design spending over the next year than mid- and large-sized firms. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are

China FDA issues draft guidance on clinical evaluation of some IVD reagents

Grace Fu Palma, China Med Device China FDA recently issued a draft guidance document on clinical evaluation basic requirements for clinical exempt IVD reagents, along with a second batch of clinical exempt class II IVD reagents – 130 reagents – to the agency’s directory. Key provisions in the draft, issued May 24, deal with the

GW Plastics acquires Ireland-based Avenue Mould Solutions

GW Plastics said today that it has bought Avenue Mould Solutions, a precision mold building, machining, and injection molding company based in Sligo, Ireland. The deal enables GW Plastics to have precision mold-making and advanced manufacturing capabilities in North America, Asia and Europe. Financial terms of the deal were not disclosed. “GW Plastics is thrilled to

Chinese regulators starting medical device clinical trial inspection program

By Stewart Eisenhart, Emergo Group The China Food and Drug Administration (CFDA) plans to begin conducting on-site inspections of clinical trials for medical devices in an effort to improve clinical data used in premarket review decisions. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the

Clinical evaluation reports and China: What you need to know

Grace Fu Palma, China Med Device China introduced new requirements for clinical evaluation reports in 2015. Understanding the China Food and Drug Administration’s new CER requirements can help companies to be better prepared in their CFDA submissions. 1. Summarizing data The CER must summarize the data from clinical literature, clinical experience, and clinical trials, etc.

How FDA is promoting safety, quality in clinical trials done in India

Dr. Leslie Ball; Letitia Robinson, PhD, RN; and Dr. Elizabeth Wiley After more than 16 hours of travel, we touch down in Mumbai late in the evening and are greeted by a wave of heat and humidity as we exit the airport terminal. As we drive from the airport to the hotel, the vast Mumbai

DeviceTalks Minnesota: Here’s what you missed

Some of the medical device industry’s top leaders and experts gathered in St. Paul, Minn., in June for DeviceTalks Minnesota. Check out the highlights – and don’t miss DeviceTalks Boston on October 2. [View the story “DeviceTalks Minnesota: Here’s what you missed” on Storify]

2 recent scientific advances suggest encouraging future for precision medicine

Dr. Janet Woodcock FDA helps bring precision medicine – in the form of targeted therapies — to people living with diseases that have specific genetic features. Two recent FDA drug approvals point to an encouraging future for “precision medicine” — an approach for disease treatment that tailors medical therapies, including medications, to the needs of

How Bigfoot Biomedical wants to disrupt diabetes care

Bigfoot Biomedical is a highly competitive player in medtech’s race to develop an artificial pancreas. The 50-person company has made rapid progress towards developing a smart, automated insulin delivery system since its beginnings in 2014. Just yesterday Bigfoot announced that it is partnering with Abbott, bringing together Abbott’s FreeStyle Libre glucose monitoring tech and Bigfoot’s insulin

FDA recognizes UL 2900 cybersecurity standards

By Stewart Eisenhart, Emergo Group A set of standards published by UL to address medical device cybersecurity issues will soon be adopted by the US Food and Drug Administration to help manufacturers support security assurance claims. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the

RJG Technologies gets PAA VQ\SET recognition and ISO certification

RJG Technologies has announced that it has received ISO 9001:2015 certification and PAA\VQ-SET center recognition. The PAA\VQ-SET center recognition allows RJG to enroll people in the level 3 diploma for polymer processing operations that is part of its apprenticeship. “This center recognition will enable RJG to manage the enrollment of apprentices for the qualification that

Who could replace Zimmer Biomet’s CEO?

Zimmer Biomet surprised this week with the announcement that CEO David Dvorak is immediately stepping down. So who will replace him? For now, the orthopedic device giant’s SVP and CFO Dan Florin will serve as interim CEO while the company’s board searches for a new permanent CEO. It is unclear whether Florin – who was VP and

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MedPlast acquires Coastal Life

MedPlast announced that it has acquired Coastal Life Technologies, its second acquisition in a three-month span. The financial details of the deal were not disclosed. MedPlast is working to expand its services and network of global manufacturing facilities to the world’s largest OEM. The acquisition of Coastal Life extends MedPlasts medical device assembly sites to

Brazil adds Irish Standards Authority to accredited list of MDSAP auditors

By Stewart Eisenhart, Emergo Group Brazilian medical device regulators have recognized the National Standards Authority of Ireland (NSAI) as accredited to conduct quality system audits under the Medical Device Single Audit Program (MDSAP). Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and