By Ronald Boumans, Emergo Group On October 4, the Medical Devices Coordination Group (MDCG) issued a guidance document on the validity of certificates issued under the (Active Implantable) Medical Devices Directive (AIMDD), following the Date of Application of the Medical Devices Regulation (EU) 2017/745 (MDR). These so-called “legacy devices” can be placed on the market […]
In2Bones launches bone graft harvester and backfill plugs
In2Bones today said it launched its CoLink Bone Graft Harvester and Tribio Backfill Plugs System in the U.S. The CoLink Bone Graft Harvester is a minimally invasive bone graft device that harvests bone from different parts of the body, which includes the calcaneus, iliac crest, proximal tibia, distal tibia and distal femur. The device is designed […]
Okami Medical wins FDA clearance for vascular occlusion system
Okami Medical yesterday said it won FDA 510(k) clearance for its LOBO Vascular Occlusion System. The Low-Profile Braided Occluder (LOBO) system helps patients and physicians with the occlusion of peripheral blood vessels. The system uses HDBraid technology to give physicians a minimally invasive platform for rapid and focal occlusion of a wide range of arterial […]
ICU Medical to acquire Pursuit Vascular
ICU Medical (NSDQ:ICUI) ICU Medical today said it will acquire Pursuit Vascular for $75 million. Through the definitive agreement, ICU Medical will have additional earnout payment potentially due in 2021. “ICU Medical has always been deeply focused on improving patient safety and creating the best workflow for clinicians. The ClearGuard HD is natural extension of our […]
Stryker to acquire Wright Medical for $4.7B
Stryker (NYSE:SYK) today said it is acquiring Wright Medical (NSDQ:WMGI) for $4.7 billion in cash. Through the agreement, Stryker will pay $30.75 per share and will acquire all of the issues and outstanding ordinary shares of Wright Medical for an equity value of $4.7 billion. With outstanding convertible notes, total enterprise value is set at $5.4 billion. The […]
These 10 medtech companies care a lot about research
These 10 medical device companies spent the largest portion of their budgets on research and development. Here’s a look at what they produced. Each year, Medical Design & Outsourcing compiles a list of the top 100 medical device companies across the globe and ranks the companies based on annual revenue for the most recent fiscal year. We […]
How to improve usability for wearable injector devices
By Andrew Micek, Emergo Group A new article provides step-by-step tips to help wearable injector medical device manufacturers improve design and reduce common use errors. 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 MassDevice.com or […]
DEKRA appointed first Notified Body to European IVDR
By Ronald Boumans, Emergo Group It had already been hinted at the MDCG Stakeholders meeting of September 30th, 2019, but now it is official: DEKRA Certification GmbH in Germany (DEKRA) is the first Notified Body officially designated for the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). Get the full story here at the […]
5 medical device history museums you should know
Each year around Halloween, Medical Design & Outsourcing puts together a list of antique medical devices that might make you glad to be alive today. Historically, medical devices could be scary and unorthodox. Surprisingly, some people still thought them helpful until the FDA started preapproving devices in the 1970s. There are a handful of museums in the […]
FDA recommendations for URGENT/11 medical device cybersecurity vulnerabilities mitigation
By Stewart Eisenhart, Emergo Group Following recent identification of cyber vulnerabilities in third-party software utilized by some medical devices for network communications, the US Food and Drug Administration has issued several recommendations to manufacturers, healthcare providers and patients to manage and mitigate risks stemming from these vulnerabilities. Get the full story here at the Emergo […]
European MDCG posts guidance on MDR Summary of Safety and Clinical Performance
By Ronald Boumans, Emergo Group The European Commission has issued new guidance for manufacturers of implantable medical devices to develop Summaries of Safety and Clinical Performance (SSCP) based on Medical Devices Regulation (MDR) requirements. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only […]