BSD Medical Corp. (NSDQ:BSDM) said it’s pursuing Taiwanese marketing clearance for its BSD 2000 hyperthermia system.
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Medicare takes another look at low-dose CT scanning for lung cancer
Medicare regulators agreed this month to review their coverage decisions for low-dose computed tomography scanning in patients with lung cancer, after being petitioned by leaders from a pair of national healthcare groups.
Aurora Spine lands 510(k) nod from FDA for spinal fusion implants
Aurora Spine (TSX:ASG.V) said it won 510(k) clearance from the FDA for its TiNano coated interbody systems for spinal fusion procedures.
Hansen Medical soars on FDA win for smaller robotic catheter
California surgical robotics maker Hansen Medical (NSDQ:HNSN) won FDA clearance for a smaller version of its Magellan catheter for use in peripheral vascular interventions.
MedShape wins 510(k) clearance for femoral fixation device
MedShape said it won 510(k) clearance from the FDA for its ExoShape femoral soft tissue fastener, a shape memory polymer device used in knee reconstruction procedures.
The Atlanta-based medical device company touts the ExoShape implant, for anterior cruciate ligament reconstruction surgeries, as "the only femoral fixation device fabricated completely out of PEEK Altera polymer," according to a press release.
Ellipse Technologies lands FDA clearance for limb-lengthening device
Ellipse Technologies said it secured clearance from the FDA for its Precice 2 limb-lengthening system.
Irvine, Calif.-based Ellipse makes spinal and orthopedic devices. The devices are adjustable without an invasive procedure and mainly come in the form of remote-controlled implants.
Medtech regulation: FDA releases January 2014 510(k) decisions
TOTAL 510(k)s THIS PERIOD 229
TOTAL WITH SUMMARIES 215
TOTAL WITH STATEMENTS 14
U.S. medical device regulator to improve PMA, IDE processes
By Stewart Eisenhart, Emergo Group
Covidien’s Endo Gia stapler wins FDA nod
Covidien (NYSE:COV) won 510(k) clearance from the FDA for its Endo Gia surgical stapler.
The Endo Gia, which uses an advanced polymer felt material to provide additional support to fragile tissue, landed Japanese approval in late January.
November enforcement date for new pharmaceutical affairs law in Japan
By Stewart Eisenhart, Emergo Group
Japan’s Ministry of Health, Labour and Welfare (MHLW) has set a late November 2014 date to begin enforcing revised regulations (link in Japanese) for medical devices and pharmaceutical products.
FDA’s medtech arm aims for predictability, efficiency and balance in 2014
The FDA’s office of medical device review released its priorities for the year ahead, saying that it plans to focus on its clinical trial process and promote a better balance between pre- and post-market data aggregation.