MASSDEVICE ON CALL — A group of Senators is looking for more information on the FDA’s plans for mobile medical applications, querying federal official in attempts to "clarify any uncertainty with respect to assigning risk level of medical software."
Food & Drug Administration (FDA)
Medtech approvals: FDA releases December 2013 PMAs
Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 68
Summary of PMA Originals Under Review
Total Under Review: 54
Total Active: 23
Total On Hold: 31
FDA no longer notarizing CDRH export certificates
By Stewart Eisenhart, Emergo Group
The US Food and Drug Administration has stopped notarizing Center for Devices and Radiological Health export certificates including Certificates to Foreign Government (CFG), Certificates of Exportability and Non Clinical Research Use Only Certificates.
Avedro application needs more work, FDA says
Massachusetts ophthalmic devices maker Avedro has some issues to address before the company can move forward with an FDA New Drug Application for its light-based cross-linking product for treatment.
FDA puts highest-risk label on McKesson’s anesthesia system recall
Updated March 20, 2014, at 3:15 p.m. with comments from McKesson
UPDATE: Staar Surgical jumps on FDA panel nod
An FDA advisory panel voted last week to recommend approval for Staar Surgical‘s (NSDQ:STAA) Visian Toric implantable collamer lens for myopic astigmatism, sending STAA shares up nearly 17% today.
FDA panel recommends approval of Staar Surgical’s novel eye implant
An FDA panel today voted today to recommend approval for Staar Surgical’s (NSDQ:STAA) novel Visian Toric implantable collamer lens for treatment of myopic astigmatism in adults aged 21-45.
Merit Medical gets FDA’s highest-risk label over Hospira injections
FDA says NeoMedix is selling glaucoma device without approval
FDA officials chided medical device maker NeoMedix Corp. for violations of U.S. law, saying that the company is selling its Trabectome device without proper agency approval.
FDA OKs Integra LifeSciences foot bone wedges
Integra LifeSciences (NSDQ:IART) said it obtained 510(k) clearance from the FDA for its Integra titanium bone wedges.
The wedges are designed for corrective procedures, such as osteotomies, in treating fractures in foot bones, according to a press release.
SafeOp Surgical lands FDA nod for neuromonitoring device
SafeOp Surgical said it won 510(k) clearance from the FDA for its EPAD neuromonitoring device.
The Stamford, Conn.-based company develops technology used to detect peripheral nerve damage caused by nerve compression or stretching.