From 3M’s expanded 510(k) clearance for its Tegaderm dressing to Medtronic and Acacia burying the hatchet, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. InspireMD inks Taiwanese distro deal for CGuard InspireMD announced in a June 8 press release that it has signed a distribution deal with […]
Food & Drug Administration (FDA)
OncoSec wins orphan drug status for melanoma therapy
OncoSec Medical (NSDQ:ONCS) said today that its DNA-based intratumoral cancer immunotherapy, pIL-12, won orphan drug designation from the FDA for the treatment of unresectable metastatic melanoma. The drug, tavokinogene telsaplasmid, is the biologic agent delivered using OncoSec’s ImmunoPulse IL-12 electroporation device. The company’s device delivers a sequence of short-duration electrical pulses to increase the cancer […]
FDA asks Endo to pull Opana from the market over concerns of abuse
The FDA asked Endo Pharmaceuticals (NSDQ:ENDP) to pull its opioid pain med, Opana ER, from the market, saying that the benefits of the abuse-deterrent drug no longer outweigh the risks. The move marks the 1st time the federal regulatory watchdog has urged a company to remove an opioid painkiller due to concerns of abuse. “We are facing […]
Inovio launches late-stage cervical dysplasia trial after FDA lifts hold
Shares in Inovio Pharmaceuticals (NSDQ:INO) jumped more than 10% after it announced that it is launching a Phase III clinical study of its investigational DNA immunotherapy candidate designed to treat cervical dysplasia caused by human papillomavirus. The moves comes after the FDA lifted a hold that it placed on the clinical program in October last year. At […]
Diabetes double play: Medtronic launches MiniMed 670G, Dexcom wins FDA nod for Android G5 app
Medtronic (NYSE:MDT) and Dexcom (NSDQ:DXCM) today announced respective wins for their diabetes care tech, with Medtronic launching its hybrid closed loop MiniMed 670G in the US and Dexcom winning an FDA nod for a Google (NSDQ:GOOG) Android G5 Mobile application. Fridley, Minn.-based Medtronic’s MiniMed 670G is designed to automatically track and adjust blood sugar levels in patients […]
Magellan widens lead test recall
The FDA this week expanded its Class I recall of lead poisoning tests from Magellan Diagnostics to include 2 additional testing systems. The regulatory watchdog said it recalled Magellan’s LeadCare testing systems because they may underestimate blood lead levels and provide inaccurate results with venous blood samples. “Falsely lower test results may lead to improper patient […]
BD wins 510(k) for intestinal bacteria diagnostic
Becton Dickinson (NYSE:BDX) said today that it won 510(k) clearance from the FDA for its molecular test that detects harmful intestinal bacteria causing infectious diarrhea. With the approval of its BD Max extended enteric bacteria panel, the company said the majority of pathogens causing acute gastroenteritis can be detected on its automated BD Max molecular […]
AntriaBio seeks FDA nod for trial of once-weekly insulin
AntriaBio (OTC:ANTB) said today that it filed an investigational new drug application with the FDA for its once-weekly basal insulin. If the Louisville, Colo.-based company wins approval from the FDA, it plans to launch a Phase I clinical trial of AB101 in patients with Type I diabetes. The first-in-human study is slated to evaluate the […]
Medtech stories we missed this week: June 2, 2017
From Implandata receiving CE Marking to Inolife eyeing up-listing, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Dextera seeks expanded indications for MicroCutter 5/80 stapler Dextera Surgical announced in a June 1 press release that it has filed a 510(k) with the FDA for its MicroCutter 5/80 stapler. The […]
Trump budget proposes $1B FDA user fee increase
By Stewart Eisenhart, Emergo Group The Trump Administration’s proposed 2018 federal budget would boost Food and Drug Administration user fees from medical device and drug registrants by more than $1 billion, in contrast to ongoing Congressional user fee negotiations that do not include such steep increases. Get the full story here at the Emergo Group’s […]