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 […]
Food & Drug Administration (FDA)
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 […]
Bayer wins FDA nod for connected MS auto-injector
Bayer (ETR:BAYN) said yesterday that the FDA approved a supplemental biologics license application for the BetaConnect Navigator and myBetaApp – software for its electronic BetaConnect auto-injector. The company’s BetaConnect auto-injector administers Betaseron for patients with relapsing-remitting multiple sclerosis. The newly-approved software allows patients to connect their device with the myBetaApp on their mobile device or computer […]
Novo Nordisk seeks to include cardiovascular data in Tresiba insulin label
Novo Nordisk (NYSE:NVO) said today that it submitted a supplemental application to the FDA, asking to include cardiovascular data on the label of its Tresiba insulin degludec. The Danish insulin-maker asked to include data specifically from the Devote trial, which evaluated the cardiovascular safety of Tresiba compared to insulin glargine in patients with Type II diabetes. The […]
FDA deals setback to Sunovion for inhaled COPD therapy
The FDA issued a complete response letter to Sunovion Pharmaceuticals in regards to the new drug application for its eFlow chronic obstructive pulmonary disease drug-device combo. The investigational eFlow closed-system nebulizer delivers a long-acting muscarinic antagonist bronchodilator, glycopyrrolate, to reduce airflow obstruction in COPD patients. The company said it plans to work with the FDA to determine […]
FDA cybersecurity workshop offers long-term solutions for medical device sector
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration’s latest workshop on medical device cybersecurity issues, held May 18 and 19, 2017, firmly established myriad challenges in mitigating this risk, and that no easy or quick fixes are yet available to help manufacturers and other stakeholders address these challenges. Get the full story […]
