HeartSine Technologies is in more hot water with the FDA this month after receiving an agency warning letter citing medical device reporting and tracking violations at a Pennsylvania facility.
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
DEKA Medical lands clearance for cosmetic laser
DEKA Medical won 510(k) clearance from the FDA for its Synchro REPLA:Y laser. The device is indicated for the treatment of a variety of aesthetic treatments.
Weight loss: EnteroMedics lands a date with the FDA, posts continued losses in 2013
Senate bill would strip FDA’s oversight of low-risk HIT
A new bill introduced this week by a bipartisan trio of U.S. senators would remove low-risk health information technology from the FDA’s purview – and from the 2.3% medical device tax imposed under the Affordable Care Act.
Sens. Deb Fischer (R-Neb.), Angus King (D-Maine) and Marco Rubio (R-Fla.) co-sponsored the Preventing Regulatory Overreach to Enhance Care Technology (PROTECT) Act, introducing the measure on the Senate floor Feb. 10.
BSD Medical pursues Taiwanese clearance
BSD Medical Corp. (NSDQ:BSDM) said it’s pursuing Taiwanese marketing clearance for its BSD 2000 hyperthermia system.
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