Category: Regulatory/Compliance
FDA inspectors cite manufacturing violations at CooperSurgical's Texas facility, where the company produces its Uterine Manipulator Handle, Koh-Efficient and Stays devices.
The FDA issued a warning to CooperSurgical (NSDQ:COO) after inspectors noted violations at the company's Stafford, Texas, manufacturing facility.
The FDA says Sensus Healthcare's non-surgical skin cancer treatment can be used to treat keloid scars.
The FDA granted another indication for Sensus Healthcare's topical skin cancer device, for treating keloid scars.
The Danbury, Conn.-based medical device company said its SRT-100 "superficial radiotherapy" product has already won 510(k) clearance from the federal watchdog for treating some skin cancers.
Shares of Edwards Lifesciences tick up today despite news of an FDA warning letter for the implantable heart valve maker.
Investors seemed unfazed by news of a warning letter from the FDA for Edwards Lifesciences (NYSE:EW) over a Utah cardiac surgery systems plant.
The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.
By Stewart Eisenhart, Emergo Group
The US Food and Drug Administration recently issued a letter to Biosense Technologies, developer of the uCheck Urine Analyzer mobile medical application, stating that the firm's product qualifies as a medical device and must have 510(k) clearance in order to be sold in the US.
Medical device titan Boston Scientific and industry lobbying group AdvaMed respond to the FDA's latest draft guidance on medtech recalls, warning that the new language may cause more confusion than it clears.
MASSDEVICE ON CALL — The FDA's recent attempt to clear up confusion about official recall requirements got some negative reactions from members of the medical device industry, among them lobbying group AdvaMed and medical device company Boston Scientific (NYSE:BSX).
Medtronic wins CE Mark approval in the European Union for its CoreValve heart valve, for use in valve-in-valve procedures to replace failing surgically implanted replacement valves.
Medtronic (NYSE:MDT) said EuroZone regulators OK'd a pair of its CoreValve heart valves for use in valve-in-valve replacement procedures, touting the CE Mark approval as the 1st ever worldwide.
Boston Scientific wins CE Mark approval in the European Union for its Guide imaging system, designed to aid in the placement of electrodes for deep-brain stimulation therapy to treat Parkinson's disease.
European regulators gave Boston Scientific (NYSE:BSX) the green light for its Guide 3D imaging system, touting it as the "world's first" deep-brain stimulation visualization system.
The Guide device is designed to create a simulated 3D map of the brain's electrical output, to help guide the placement of electrodes that deliver electrical pulses to the brain.
