Medtech titan Medtronic (NYSE:MDT) touted a new European regulatory win for its endovascular portfolio, announcing CE Mark and planning a global launch of the Sentrant introducer sheath.
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Diabetes: J&J recalls OneTouch Verio IQ glucose meters over failure to warn at extreme levels
FDA’s new global cardiovascular registry to start with transcatheter heart valves
The FDA plans to launch a global cardiovascular medical device registry, with initial efforts to focus on coordinated efforts to monitor transcatheter heart valve technology.
The federal watchdog agency will host a public meeting later this month to discuss goals and strategies for organizing such an effort, which the FDA is calling the "International Consortium of Cardiovascular Registries."
FDA releases March 2013 510(k) clearances
March 2013 510(k) Clearances
510(k) summaries or 510(k) statements for final decisions rendered during the period March 2013.
TOTAL 510(k)s THIS PERIOD 255
TOTAL WITH SUMMARIES 243
TOTAL WITH STATEMENTS 12
Doc who designed DePuy’s metal hip tells jury he wouldn’t implant the device today
FDA OKs Hitachi Medical CT scanner
Hitachi (NYSE:HIT) said it won 510(k) clearance from the FDA for its Scenaria Advanced 128 CT scanner, the latest in its line of scalable CT scanners.
Hitachi Medical Systems America said the latest iteration of the Scenaria Advanced includes new low-dose technology designed to reduce patients’ exposure to X-ray radiation.
LensAR lands another FDA clearance for cataract laser surgery
The laser cataract surgery market has another player, now that the FDA’s cleared its laser surgery device for another type of incision used during cataract surgery procedures.
LensAR said it won 510(k) clearance from the FDA for its laser cataract surgery device for arcuate incisions to the edge of the cornea.
Australia issues warning on American Medical Systems’ urinary control systems
Australian healthcare regulators issued a safety advisory late last month on certain lots of American Medical Systems’ AMS 800 urinary control systems, warning that the devices were released on the market on the market without meeting the company’s product release criteria.
The FDA sends medtech reviewers into the field | MassDevice.com On Call
MASSDEVICE ON CALL — The FDA is looking for medical device companies to participate in its "Experiential Learning Program," so that the agency’s reviewers can get a 1st-hand look into medtech design and manufacturing.
Participating companies would host tours for healthcare regulators as part of a training mechanism to give the reviewers a sense of the medtech development life-cycle and the "challenges faced throughout development, testing, manufacturing, and clinical use," according to an FDA notice.
pSivida’s new Iluvien approval attempt focuses on safety
FDA clears Medtronic’s Affinity Fusion blood oxygenation system
Medtronic (NYSE:MDT) said the FDA granted 510(k) clearance for its Affinity Fusion blood oxygenator, used during open heart surgery to replace the function of the lungs.
The Minneapolis-area medical device company, which is the world’s largest pure-play medtech maker, said the Affinity Fusion is designed to filter a patient’s blood to remove particles and air during oxygenation.