We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Long-term results from the clinical study that supported the FDA’s approval of Channel Medsystems’ Cerene Cryotherapy system show that the device continued its steady reduction of heavy menstrual bleeding after three years. Read More
Two device companies that share the same address in Natick, Mass., have received separate warning letters from the FDA for quality system failures observed during an FDA inspection, including not fully investigating complaints and a lack of adequate corrective and preventive actions (CAPA). Read More
Establishing operational limits is a key issue to consider. These are the limits that are obtained during the operational qualification (OQ) testing over the expected operating range. Read More
Massachusetts-based Azenta is expanding its cold-chain sample management capabilities with the purchase of Luxembourg’s B Medical Systems, a leading cold-chain services provider. Read More
The initial response to the FDA’s trial opening of its Customer Collaboration Portal to premarket device submissions has been encouraging, the agency says. Read More