Increased requirements for clinical evidence under the new Medical Devices Regulation (MDR)

Europe – Effects of “No Deal” Brexit for Medical Device Sector

EMERGO SUMMARY OF KEY POINTS: A “no deal” or “Cliff Edge” Brexit is a realistic scenario, becoming more realistic every day. The UK government...
Global spinal fusion devices market poised for growth

International – Global spinal fusion devices market poised for growth

The global spinal fusion devices market is predicted to increase at a 3 percent compound annual growth rate through 2024, according to a Research and...
India still lacks comprehensive regulations for medical devices

India – India still lacks comprehensive regulations for medical devices

Thirteen years. That’s how long it has been since a direction was given to the Indian health authorities to have a comprehensive framework for...
Implants médicaux : le manque de contrôle dénoncé par un consortium de journalistes

France – Implants médicaux : le manque de contrôle dénoncé par un consortium de...

Ce sont des stents, ces petits ressorts placés dans les artères pour éviter qu’elles ne se bouchent, des cathéters, des sondes urinaires, des implants...
Biggest Regulatory Challenge is Software Safety

UK – Decide if your product is a medicine or a medical device

Overview Some products are hard to distinguish from a medicine or a medical device, for example cosmetics, food supplements or biocidal products. These products are...
U.S. and EU Agree to Work Together on UDI Standards

Europe – U.S. and EU Agree to Work Together on UDI Standards

The U.S. and the EU have pledged to cooperate to ensure that electronic database specifications for unique device identifiers (UDIs) are in alignment, according...
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...
Eximo Medical’s Atherectomy Laser Cleared by FDA

USA – Eximo Medical’s Atherectomy Laser Cleared by FDA

The FDA granted 510(k) clearance for Eximo Medical’s B-Laser atherectomy system, used for treating patients with peripheral artery disease, including in-stent restenosis. The device —...
Intracranial Hemorrhage Detection Software Receives FDA Clearance

USA – Intracranial Hemorrhage Detection Software Receives FDA Clearance

“AI and machine learning are going to transform healthcare, as they have virtually every other industry they have touched,” said Gene Saragnese, chairman and CEO...
Medical devices: the shift from embedded to connected

UK – New NICE standards to improve digital health tech uptake

Multiple recent surveys, such as a Roche investigation that revealed 82% of ‘Generation Z’ want to see the NHS introduce digital solutions, are showing...

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