Sept. 22, 2017

Mazor Robotics Snags CE Mark for Surgical Platform

The device will be marketed in Europe by the company’s commercial partner Medtronic. Read More

Masimo Wins FDA Nod for Rad-97 Pulse Oximeter

The device supports wireless connections to compatible thermometers, glucometers, and weight scales. Read More

FDA Spells Out Which Microneedlers Are Medical Devices

Not covered by the guidance are acupuncture needles, hypodermic needles, tattoo needles or laser and ultrasound needle probes. Read More

FDA to Launch PMA Pilot Program This Month

The PMA pilot program is a joint effort between CDRH and the Office of Regulatory Affairs. Read More