California neurostimulation devices maker NeuroPace crept 1 step closer to an FDA win for its epilepsy implant with near-unanimous approval from the FDA’s Neurological Devices Advisory Panel.
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
FDA OKs Wellaho mobile patient health monitoring system
California mobile health services company Sanitas won FDA clearance for its Wellaho system, a proprietary mobile and online platform providing a link between patients and healthcare providers.
The Wellaho platform is "an outpatient management system for chronically ill patients," according to the company’s website.
Biotronik lands Euro approval for MRI-friendly heart implants
German medical device maker Biotronik won European regulatory approval for its Ilesto 7 line of MRI-friendly heart implants.
The Ilesto 7 line includes cardiac resynchronization therapy defibrillator and one of the world’s smallest implantable cardioverter-defibrillators, according to Biotronik.
Abiomed shares open up 3% after FDA closes out warning letter
INMETRO certification changes in Brazil
By Stewart Eisenhart, Emergo Group
INMETRO Safety certification for medical devices with electrical and other components has changed in Brazil.
FDA approves new breast implants by Allergan, requires post-approval studies
Stryker recommends more vigilant monitoring of patients with recalled hip implants
MEDEC analysis: Increased review times at Health Canada
By Stewart Eisenhart, Emergo Group
An analysis Health Canada data by Canadian medical device trade association MEDEC has found increasing review times and screening deficiencies for Medical Device License applications during the fourth quarter of 2012.
Breast cancer: Dune Medical wins EU nod for next-gen tissue screening system
Dune Medical Devices won European regulatory approval for the latest generation of its breast cancer detection tool, the MarginProbe System Type 1.2 console.
Abbott’s MitraClip gets a date with the FDA
FDA approves Lombard Med. Tech.’s Aorfix stent graft for treating highest neck angulation
British medical device maker Lombard Medical Technologies (LON:LMT) won premarket approval from the FDA to market its Aorfix flexible stent graft in the U.S.