By Stewart Eisenhart, Emergo Group US Food and Drug Administration user fee increases in the Trump Administration’s proposed 2018 federal budget would disproportionately impact smaller medical device companies, as these firms make up the majority of the US medical device industry. Get the full story here at the Emergo Group’s blog. The opinions expressed in […]
Food & Drug Administration (FDA)
Facing pressure from pharma, FDA delays off-label promotion rule
After pharmaceutical industry groups filed a petition against the FDA’s new off-label promotion rule, the federal watchdog agency said last week it would delay the rule’s implementation to March 19, 2018. The agency originally intended for the law to go into effect on March 21 this year. The rule would expand the evidence that the […]
Medtech stories we missed this week: March 17, 2017
The FDA awarded 510(k) clearance to a couple of medtech companies this week while others received tax breaks and incentives, including a local tax break for a $154 million Stryker R&D facility planned in Michigan. Here are some medtech stories we missed this week but thought were worth mentioning. 1. FirstRay wins FDA 510(k) clearance […]
510(k) submissions to FDA declining
By Stewart Eisenhart, Emergo Group The number of US-based medical device manufacturers submitting 510(k) premarket notification applications to the Food and Drug Administration has decreased over the past four years, according to a new Emergo study, while applications from European and Asian firms have increased. Get the full story here at the Emergo Group’s blog. […]
FDA proposes exempting 337 Class II devices from 510(k) requirements
By Stewart Eisenhart, Emergo Group US medical device regulators at the Food and Drug Administration (FDA) have proposed exempting hundreds of moderate-risk devices from 510(k) premarket notification requirements as the agency begins implementing components of the 21st Century Cures Act passed in late 2016. Get the full story here at the Emergo Group’s blog. The […]
FDA panel rules that benefits of Endo’s Opana opioid no longer outweigh risks
An FDA advisory panel ruled yesterday that the benefits of Endo Pharmaceutical‘s opioid painkiller, Opana ER, no longer outweigh its risks. The painkiller has been linked to a 2015 HIV outbreak in Indiana after people addicted to opioids shared needles while injecting Opana. The panel voted 18 to 8 that the drug’s benefits do not […]
Medtronic’s SynchroMed woes delay United Therapeutic’s Remodulin
Shares in United Therapeutics (NSDQ:UTHR) fell -3% yesterday on a possible delay for the release of a programmable infusion pump for its drug, Remodulin. Yesterday, the FDA updated Medtronic‘s (NYSE:MDT) Class I recall for the company’s SynchroMed II and SynchroMed EL implantable drug pumps. RBC Capital reportedly said the recall puts United Therapeutics at heightened risk for […]
Prometra micro-infusion device used to deliver meds directly to brain in epilepsy trial
Flowonix Medical and Cerebral Therapeutics said today that the 1st patients were implanted with the Prometra II programmable infusion system in a clinical trial evaluating the pump in patients with refractory epilepsy. The Address trial marks the 1st time a programmable, implantable pump has been used to deliver medication, in this case valproate, directly to […]
FDA announces updates to Medtronic’s Class I recall for SynchroMed drug pumps
The FDA today updated Medtronic’s Class I recall for the company’s SynchroMed II and SynchroMed EL implantable drug pumps, which were designed to locally treat primary or metastatic cancer, chronic pain, and severe spasticity. The pumps were recalled in 2013 because they unintentionally delivered drugs during the priming bolus procedure and patients were at risk for […]
Trump’s pick for FDA chief faces questions over ties to drug industry
Although President Donald Trump’s nominee for FDA commissioner has won approval from lawmakers across the aisle, he is facing questions from consumer watchdog Public Citizen over his ties to the drug industry that will likely arise during his confirmation hearings. The Medical Device Manufacturer Association has voiced its approval for Scott Gottlieb, saying “Dr. Gottlieb is a […]
