Boston Scientific's Guidezilla Guide Extension Catheter has secured 510(k) approval from the US Food and Drug Administration (FDA) and CE Mark, which would enable the company to market the device in the US and European markets. The ...
On September 1, 2013, the latest energy efficiency requirements for LED lighting products will be officially implemented in Europe. European energy efficiency requirements are mainly based on the requirements of the EU's ErP. Like LVD ...
Tags: LED Lighting, Energy, Lights, LED
Sweden-based Episurf Medical has secured CE Mark approval for its Episealer Femoral Condyle, a personalized implant that helps in treating the damage in knee cartilage. The company obtained CE Mark after the product and its technical ...
Tags: Episurf Medical, CE Mark, Knee Implant
US-based NanoString Technologies has announced that its Prosigna Breast Cancer Prognostic Gene Signature Assay offers better prognostic information in endocrine treated patients with HR+ node negative disease. NanoString Technologies said ...
Tags: Prognostic Information, Medicine
US-based NanoString Technologies has announced that its Prosigna Breast Cancer Prognostic Gene Signature Assay offers better prognostic information in endocrine treated patients with HR+ node negative disease. NanoString Technologies said ...
Tags: Prognostic Information, Medicine
Miraculins, a Canada-based medical diagnostic company, has acquired VeraLight's SCOUT DS technology, which screens diabetes by non-invasively measuring changes in the skin composition. These changes in the skin composition indicates ...
Tags: Miraculins, Screening Technology
Merit Medical, US-based cardiology, radiology and endoscopy disposable devices manufacturer and distributor, has received multiple regulatory approvals from various regulatory bodies. Merit's advanced high-pressure inflation device, ...
Tags: Merit Medical, Medical Devices
BD Diagnostics and Diagenode have jointly announced the Europe-only launch of a new real-time Diagenode Bordetella pertussis/parapertussis real-time polymerase chain reaction (PCR) kit for use on the BD MAX System. Timely detection of ...
Tags: BD Diagnostics, PCR Kit
CryoLife, a US-based tissue processing and medical device company, has secured conditional US FDA approval of its Investigational Device Exemption (IDE) for PerClot. A hemostat made of absorbable polysaccharide granules, PerClot is ...
Tags: Cryolife, Trials of Perclot
Mendor, a Finland-based diabetes technology firm, has received CE Mark clearance for its diabetes management cloud-based platform, Mendor Balance. Delivering benefits to patients, health care professionals, payers and the pharma industry, ...
Codman Neuro, a part of DePuy Synthes Companies of Johnson & Johnson, has received CE Mark clearance for its Revive Se, the next generation self-expanding clot removal device for use in treating acute ischemic stroke. The Revive Se device ...
Tags: Codman Neuro, CE Mark
Micell, a US-based biomedical company, has received CE (Conformité Européenne) Mark clearance for its MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES). MiStent Sirolimus Eluting Absorbable ...
Tags: Micell, Mistent SES
Medtronic has received CE Mark (Conformité Européenne) for its ReDuX Plier, a new instrument specially intended for use during osteotomies. With the approval, the company has also announced the launch of the surgical ...
US-based privately held medical device company RSB Spine has inked an exclusive distribution and licensing agreement with JMF (T) Group, a Thailand company of German manufacturer of spinal and orthopedic implants Mahe Medical. As per the ...
Integrity Applications, an Israel-based medical device company, has received CE Mark approval for its GlucoTrack DF-F non-invasive device. The GlucoTrack DF-F is a glucose measuring device that uses a patented combination of ultrasound, ...