The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Penumbra said it won Shonin approval from the Japanese Ministry of Health, Labor and Welfare for its Penumbra Coil 400 intracranial aneurysm device.
The Alameda, Calif.-based medical device company said it plans to launch the device immediately via an exclusive distribution agreement with Japan’s Medico’s Hirata.
St. Jude Medical (NYSE:STJ) announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare for its Fortify implantable cardioverter defibrillator and Unify cardiac resynchronization therapy defibrillator, and the company launched the products in the Japanese market.
A ICD is an device that treats abnormally fast heart rhythms, and a CRT-D resynchronizes beating in the heart’s lower chambers, which often beat out of sync in heart failure patients.
The FDA released a flurry of recalls for medical devices this week.
First, iCad Inc. (NSDQ:ICAD), formerly Xoft Inc., had to remove a radiation guard for breast cancer treatment, over reports that the device sheds tungsten particles.
The FDA issued the Class I recall for Sunnyvale, Calif.-based company’s Axxent FlexiShield Mini, Model F5300. The Food & Drug Administration issues Class I recalls when there is potential for serious injury or death from use of a particular device or product.
