Longer, more extensive studies and a focus on subjective quality of life outcomes were among the top agreed upon recommendations for future trials studying transvaginal mesh implants used for treating pelvic organ prolapse, according to a MedTech Dive report covering the recently held FDA transvaginal mesh advisory panel. While the panelists didn’t vote on any […]
Check-Cap’s cancer screening capsule will have U.S. study
Check-Cap (NSDQ:CHEK) said its X-ray-enabled, colorectal cancer-screening capsule will have a pilot study in the United States. The Isfiya, Israel-based startup makes the C-Scan System, an ingestible capsule used to detect precancerous polyps without the need for laxatives or an invasive procedure. The C-Scan system uses an ultra-low dose X-ray capsule, an integrated positioning, control, and recording system, and proprietary […]
Brain tumor ‘monorail’ lands FDA breakthrough device nod
A “tumor monorail” that lures aggressive brain tumor cells to their death in an external container has won “breakthrough device” designation from FDA. The purpose of the device is not to destroy the glioblastoma tumor, but to halt its lethal spread, making the disease more of a condition to manage than a death sentence, according […]
Number of cancer cases linked to breast implants soars
FDA said it has received reports of 457 unique cancer cases related to breast implants since 2010, including nine patient deaths. The agency identified those unique cases from a total of 660 adverse event reports in the U.S. from 2010 through September 2018, including 246 new adverse event reports since 2017. FDA began reporting on cases […]
FDA publishes finalized guidance for buprenorphine depots
The FDA this week published a finalized guidance document for companies developing new buprenorphine depot products for the treatment of opioid use disorder. The agency is hoping to boost the development of modified-release buprenorphine products, like drug-eluting implants. In the document, the FDA detailed the studies needed to support approval for these products through the 505(b)(2) pathway. Get […]
Mylan wins race for generic Advair approval
FDA has approved the first generic of GlaxoSmithKline‘s (NYSE:GSK) blockbuster Advair respiratory drug, this one by Mylan (NSDQ:MYL), six months after rejecting Mylan’s application. Canonsburg, PA-based Mylan’s shares jumped 7% to $30.82 at market close after yesterday’s late-afternoon announcement, and were trading at $30.96 mid-morning today. GSK’s stock dipped 2% to$38.70 on the news late yesterday, but had more than […]
FDA approves J&J’s Tremfya self-injection pen for psoriasis
FDA has approved Johnson & Johnson’s patient-controlled injector for Tremfya, a treatment for adults with moderate to severe plaque psoriasis. The self-injection approval may help Tremfya compete with AbbVie’s (NYSE:ABBV) Humira pen, which was previously approved for self-injection by psoriasis patients. Get the full story on our sister site, Drug Delivery Business.
FDA sets approval record, lays out 2019 strategy
FDA said today that it set a record for novel-device approvals in 2018, giving the nod to 106 new devices, breaking the previous record of 99. The agency also granted nine breakthrough device designation requests, for a total of 112 since the program’s inception in 2015. Novel-device approvals in 2018 included an expanded approval of an […]
FDA clears Imperative Care’s stroke treatment catheters
Stroke-treatment startup Imperative Care (Campbell, Calif.) said it has landed FDA approval for its first line of access catheters. Access to brain blood vessels can be challenging because of the brain’s highly complex and twisted vascular structure. The catheters were designed to deliver interventional treatments during minimally invasive neurovascular procedures for aneurysms, stroke, and other brain blood-vessel […]
Applied Tissue Technologies’ negative-pressure dressing gets FDA nod
Wound-care company Applied Tissue Technologies said it has won FDA clearance of its negative-pressure wound therapy product, the Platform Wound Dressing (PWD). The class II device represents the first-of-its-kind embossed negative pressure wound therapy device to be used without foam or gauze, according to the Hingham, Mass. company. The PWD is a transparent dressing with […]
RFPi wins FDA nod for non-contact blood flow imaging tech
FDA has cleared RFPi’s iCertainty real-time, noninvasive blood flow and perfusion imaging medical device for use during surgical procedures, the company said. iCertainty is the first medical imaging device to show blood flow without interrupting a surgical procedure or requiring injections, dyes, radiation or direct patient contact, according to the Greenville, N.C. company. Use of iCertainty during surgery could reduce […]
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