The inspector general’s office at the U.S. Health & Human Services Dept. plans to investigate the security of networked medical devices in hospitals, according to the HHS OIG’s work plan for fiscal 2016. “We will examine whether FDA’s oversight of hospitals’ networked medical devices is sufficient to effectively protect associated electronic protected health information (ePHI) […]
Food & Drug Administration (FDA)
Perspectum Diagnostics wins FDA 510(k) for LiverMultiscan MR device
Perspectum Diagnostics said it won FDA 510(k) clearance for its LiverMultiscan MR imaging device designed to detect early liver disease. The LiverMultiScan uses quantitative MR methods and provides a highly detailed map of the whole liver for clinicians to identify regions of disease, the U.K.-based company said. Perspectum Diagnostics said the device is currently used […]
InnFocus wins FDA clearance for glaucoma trial expansion
InnFocus said today it won FDA approval to expand a clinical study of its Microshunt glaucoma drainage system to cover trabeculectomy. The Microshunt system is designed to help reduce pressure within the eye in patients with moderate and late stage open angle glaucoma, and is intended to be an alternative to traditional glaucoma surgery, the […]
ReVision Optics files for PMA for presbyopia inlay
ReVision Optics said today the FDA accepted its premarket approval application for the Raindrop near vision inlay. The Raindrop is a microscopic hydrogel inlay for treating presbyopia, which the Lake Forest, Calif.-based company said could reduce or eliminate the need for reading glasses. The inlay is placed in the cornea of the patient’s non-dominant eye […]
Si-Bone wins FDA 510(k) for iFuse sacroiliac joint system
Si-Bone said today it won FDA 510(k) clearance for its minimally invasive iFuse implant system designed for fusion of the sacroiliac joint. The device is cleared for treating certain disorders of the sacroiliac joint, and its indication includes a statement that treatments with the device “improved pain, patient function and quality of life at 12-months […]
House bill would ban Bayer’s Essure
A bill introduced by Rep. Mike Fitzpatrick (R-Pa.) would ban U.S. sales of the Essure female sterilization implant made by Bayer (ETR:BAYN). The “E-Free Act” or H.R. 3920 was introduced Nov. 4 and has 3 co-sponsors: Reps. Marsha Blackburn (R-Tenn.), Gregorio Sablan (I-N. Mariana Islands) and Christoper Smith (R-N.J.). It would direct the FDA commissioner to withdraw approval for the Essure device, the only approved permanent […]
FDA clears Edap’s Ablatherm prostate device
Edap (NSDQ:EDAP) said today that it won 510(k) clearance from the FDA for its Ablatherm, less than a month after a similar device from rival SonaCare won a nod from the federal safety watchdog. The Ablatherm device, like SonaCare’s Sonablate 450, is designed to ablate prostate tissue using high-intensity focused ultrasound. After a years-long dance with the FDA that […]
FDA: Inspections up, warning letters down in 2014
The FDA released its quality system inspection data for 2014 this week, reporting a higher number of inspections, but less warning letters sent compared with 2013. In 2014, the Agency said it inspected 2,213 medical device quality systems, slightly higher than the 2,201 the agency reported inspecting in 2013. The FDA produced less warnings letters […]
Guided Therapeutics pushes back FDA date for LuViva device
Guided Therapeutics (OTC:GTHP) said today the FDA granted a request to reschedule a meeting to discuss its stalled bid for pre-market approval for its LuViva cervical scan device. Norcross, Ga.-based Guided Therapeutics said it’s now scheduled to meet with the FDA on Nov. 30 to discuss its plans to submit the application for the cervical scan device. […]
TherOx wins FDA IDE nod for Supersaturated Oxygen therapy
Irvine, Calif.-based oxygenation therapy company TherOx said today it won FDA investigational device exemption approval to test its 2nd-generation Supersaturated Oxygen therapy system for treating acute myocardial infarction. The company’s SSO2 therapy is designed to reduce infarct size by increasing oxygen delivery to heart muscle immediately after the coronary artery has been opened through a […]
INVO Bioscience wins FDA de novo approval for InvoCell
INVO Bioscience said yesterday it won FDA de novo approval for its INVOcell intravaginal culture infertility treatment system. The company said it is the 1st intravaginal culture system with marketing clearance in the U.S. INVOcell is designed for incubating eggs and sperm during fertilization during early embryo development and operates within a woman’s body, unlike in […]