Is Progress on MDR and IVDR Happening Fast Enough?
One year into the transition periods for the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), industry experts continue to express concern that more progress is needed to help companies prepare for the new regulations within the limited transition period.
Intracranial Hemorrhage Detection Software Receives FDA Clearance
Artificial intelligence–powered software prioritizes the assessment of computed tomography cases that may have indications of brain bleed.
Edwards’ Sapien 3 Ultra Valve Wins CE Mark
span style=”font-weight:normal;”>News of Edwards Lifesciences’ CE mark for Sapien 3 Ultra was dampened by Boston Scientific’s preliminary injunction on the device in Germany.
GE Recalls Nearly 1,000 Diagnostic Imaging Systems Due to Detachment Risk
The recall was prompted by an incident in which the top detector of a Millennium Nuclear Medical System detached and fell onto the detector below.
What Does the Future Hold for Robotic Surgery?
Exploring the current state of robotic-assisted surgery and what to expect from future surgical robots.
Wireless Wearables: Challenges to Tackle
A presentation at the upcoming BIOMEDevice San Jose show will cover issues in connectivity for this growing segment of the medical device industry.
How Smart are Your Design Inputs?
A medical device expert shares tips for creating clear and objective design inputs.
Another Chance for Medtronic’s Renal Denervation Therapy
The Dublin-based company has received FDA approval to begin a clinical trial to evaluate the Symplicity Spyral renal denervation system with patients on medication for high blood pressure.
8 Things You Should Know about the EU MDRs
Respondents to a recent survey on the new EU regulation raise some concerns about readiness. Are you prepared?
Medtec China 2018 was successfully held in Shanghai this past September; 90% of the booths for next year have been booked
Medtec China 2018 was successfully held at the Shanghai World Expo Exhibition & Convention Center September 26–28th, 2018. The three-day event succeeded in bringing together 354 exhibitors from 23 countries and regions of the world
