Medtronic (NYSE:MDT) said today that the 1st patient was enrolled in a study of its In.Pact Admiral drug-coated balloon in patients with end-stage renal disease. The FDA approved the investigational device exemption study to evaluate the device as a treatment for failing arteriovenous fistulas in end-stage renal disease patients. Get the full story at our sister […]
Food & Drug Administration (FDA)
Trump proposes deep cuts to Medicaid, NIH funding
President Donald Trump’s proposed budget would slash Medicaid funding and cut support for major biomedical research programs at the National Institutes of Health and the Centers for Disease Control & Prevention. The budget blueprint drew condemnation from healthcare advocates and lawmakers from both sides of the aisle. Senate majority whip Sen. John Cornyn (R-Texas) reportedly said earlier […]
Cerus lowers Intercept sales guidance after Fresenius Kabi supply snafu
Cerus (NSDQ:CERS) said today that it expects a U.S. supply shortage of Fresenius Kabi’s (NYSE:FMS) platelet additive solution will impact blood centers that use PAS to produce Intercept platelets. The pending shortage is due to “an unanticipated delay” in FDA approval of a plastic component used to manufacture the PAS container. The original component was discontinued […]
Proteus, Otsuka take another run at FDA approval for Abilify-smart pill combo
Otsuka Pharmaceutical (TYO:4578) and Proteus Digital Health said today that the FDA accepted its resubmitted new drug application for their “smart pill”. The drug-device product combines Abilify and a Proteus ingestible sensor in a single tablet. The FDA is slated to make a decision on the NDA resubmission in the 4th quarter this year. Get the […]
Symic Bio raises $30m for peripheral vein graft failure therapy
Symic Bio said yesterday that it raised $30 million in a Series B financing round, led by existing investors and HEDA Ventures. Funds from the round are slated to support the company’s clinical programs, including a drug designed to prevent peripheral vein graft failure, SB-030, and a therapy for pain management of osteoarthritis of the knee, […]
FDA labels Philips Respironics V60 ventilator recall as Class I
The FDA today labeled a recall of Royal Philips (NYSE:PHG) Respironics‘ V60 ventilators as Class I. Class I recall designations, the agency’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death. The Respironics V60 non-invasive ventilator is designed to provide continuous or […]
Soterix Medical wins FDA 510(k) for IontoDC
Soterix Medical said today it won FDA 510(k) clearance for its IontoDC device designed to use direct current to introduce ions of soluble salts and other drugs into the body. The New York-based company said that the newly-cleared IontoDC device provides 10, 20, 30 or 40 minutes of direct current at intensities varying between 1 and […]
Anika touts Phase III data for Cingal knee therapy
Anika Therapeutics (NSDQ:ANIK) touted data today from a Phase III trial for its Cingal hyaluronic acid-corticosteroid combination viscosupplement as a treatment for osteoarthritis-related knee pain. The data showed that treatment with Cingal yielded better immediate and short-term pain relief compared to hyaluronic acid alone and better pain and stiffness relief through 26 weeks compared to saline. […]
Intersect ENT updates on Sinuva steroid-releasing sinus implant
Intersect ENT (NSDQ:XENT) said today that the FDA is slated to make a decision on its new drug application for the Sinuva steroid-releasing sinus implant by January 7, 2018. The Sinuva implant, which was previously called the Resolve implant, is placed during an in-office doctors appointment and is designed to be a treatment option for […]
ViaCyte looks to cell replacement therapy to cure Type I diabetes
ViaCyte said today that it will begin clinical trials of its novel islet cell replacement therapy in development as a potential cure for Type I diabetes, after landing regulatory wins from the FDA and Health Canada. The company’s PEC-Direct candidate delivers stem cell-derived pancreatic progenitor cells in a device that is designed to enable direct […]
7 medtech stories we missed this week: May 19, 2017
From FDA clearances to touting study data, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. XpandOrtho wins FDA 510(k) clearance XpandOrtho announced in a May 17 press release that it has received FDA 510(k) clearance for its electronic soft tissue balancing instrument for total knee replacement surgery. […]