10 of the Most Influential Companies in the Cardiovascular Space

International – 10 of the Most Influential Companies in the Cardiovascular Space

The cardiovascular space has been among the most exciting in medtech in recent years. A special panel at MD&M East, "Unmet Needs Straight from...
FDA permits marketing of first diagnostic test to aid in detecting prosthetic joint infections

USA – FDA permits marketing of first diagnostic test to aid in detecting prosthetic...

Today, the U.S. Food and Drug Administration permitted marketing of the Synovasure Lateral Flow Test Kit as an aid for the detection of periprosthetic...
FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies

USA – FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies

Today, the U.S. Food and Drug Administration authorized marketing of a diagnostic test to detect Zika virus immunoglobulin (IgM) antibodies in human blood. The ZIKV Detect...
FDA clears first diagnostic tests for extragenital testing for chlamydia and gonorrhea

USA – FDA clears first diagnostic tests for extragenital testing for chlamydia and gonorrhea

Today, the U.S. Food and Drug Administration cleared for marketing two tests that can detect the presence of the bacteria Chlamydia trachomatis and Neisseria...
Developing a Wearable Display for Surgeons

USA – Developing a Wearable Display for Surgeons

Cameras and screens have been used to augment surgeons’ vision for years, enabling them to see magnified surgical sites for greater precision. But as...
Spring Regulatory Agenda for FDA: What New Rulemakings are Coming

USA – Spring Regulatory Agenda for FDA: What New Rulemakings are Coming

The US Food and Drug Administration (FDA) on Wednesday published its plans for the latest proposed and final rulemakings for drug and medical device...
May 2019 Regulatory Roundup: Europe on the verge of MDR

Europe – May 2019 Regulatory Roundup: Europe on the verge of MDR

With the European Medical Devices Regulation (MDR) coming into force in less than one year, plus related challenges such as Brexit, Notified Body capacity...
Changements significatifs dans le cadre de la période transitoire (article 120) : Guide GMED pour l’interprétation

Europe – Changements significatifs dans le cadre de la période transitoire (article 120) :...

En vue de répondre aux attentes de ses clients concernant la mise en œuvre des dispositions transitoires prévues par l’article 120 du Règlement (UE)...
TÜV SÜD Becomes Second NB to be Designated Under EU MDR

Europe – TÜV SÜD Becomes Second NB to be Designated Under EU MDR

Germany-based TÜV SÜD Product Service GmbH Zertifizierstellen on Wednesday became the second notified body (NB) to be designated and notified under the EU Medical...
Taux de croissance de la production du marché des dispositifs médicaux connectés 2019-2025

International – Taux de croissance de la production du marché des dispositifs médicaux connectés...

Un rapport de recherche sur le « marché des dispositifs médicaux connectés » , établi par QYMarketStudy, présente une analyse concise des tendances les plus récentes du marché....

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