Volume 9 Issue No. 28
Zimmer Biomet CEO David Dvorak Resigns
By MedTech Intelligence Staff
After the abrupt announcement, the search is on for a permanent successor.
Edwards Lifesciences Receives FDA Approvalfor Its New Class of Heart Valves
The Inspiris Resilia valve is intended for aortic valve replacement.
Cybersecurity and Medical Device Recalls
By Chris Harvey, Stericycle
When a software patch or device update cannot remedy a cyber threat, sometimes a recall is necessary.
FDA Expands Clearance of Cooling Cap to Minimize Hair Loss During Chemotherapy
The agency has cleared expanded use of the DigniCap for solid tumor cancers beyond breast cancer.
Spectranetics’ highly competitive product range, integrated with our portfolio of interventional imaging systems, devices, software and services will enable clinicians to decide, guide, treat and confirm the appropriate cardiac and peripheral vascular treatment to deliver enhanced care for patients with better outcomes, as well as significantly boost recurring revenue streams for Philips.
— Frans van Houten, Royal Philips
Diagnose Heart Disease in One Click
European scientists have developed a handheld scanner that works similar to a supermarket scanner for early detection of cardiovascular disease.
FDA Reviewed Your Response, and It’s Not Adequate
By Christopher Devine, Ph.D.,Devine Guidance International
When responding to a 483 observation, clarity is a must: Both in communication and documentation.
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August 29-30, 2017 - The New EU Medical Device & IVD Regulations
A Virtual Conference
Q3 2017 - Medical Device Statistics for Non-Statisticians
October 23, 24, 25, 2017 - Premarket Submissions
Menlo Park, CA
November 2-3, 2017 - China: The MedTech Market
Q4 2017 - Combination Products: A Conference for Drug, Device, Diagnostics, & Biologics Manufacturers