From ReShape submitting an approval application to Health Canada to Conavi receiving FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. ReShape submits for Health Canada approval of ReShape balloon ReShape announced in a May 10 press release that it has submitted an application to the Medical Devices Bureau […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Cardinal Health’s Cordis wins date with FDA panel for Incraft AAA stent graft
Cardinal Health (NYSE:CAH) subsidiary Cordis this week won a June date with an FDA panel looking to discuss the premarket approval application for its InCraft AAA stent graft system designed for treating infrarenal abdominal aortic aneurysms. On June 12, the FDA’s Medical Device Advisory Committee’s Circulatory Systems Devices Panel will meet to discuss possible marketing applications for […]
Manufacturing delays lead to Epipen shortage in U.S.
At least 400 people across the U.S. have had trouble getting their hands on an Epipen in recent weeks, according to a survey from the advocacy group Food Allergy Research & Education. Mylan (NSDQ:MYL), which makes the emergency allergy auto-injector, reportedly told the FDA months ago that manufacturing delays were straining its Epipen supply. Get the […]
Cook Medical wins FDA de novo nod for Hemospray
Cook Medical said yesterday it won FDA de novo clearance for its Hemospray endoscopic hemostat designed for treating bleeding in the gastrointestinal tract. The Hemospray product won indications from the FDA for treating non-variceal GI bleeds, the Bloomington, Ind.-based company said. Hemospray is a single-use device designed to deliver an aerosolized spray of a mineral blend […]
Medtronic initiates select recall of Covidien Endo GIA staplers
Medtronic (NYSE:MDT) this month issued a select recall for specific Covidien Endo GIA staplers over possible missing components, according to a safety field notice from the company. The Fridley, Minn.-based company warned that the Endo GIA articulating loading units could possibly be missing a sled component designed for staple deployment, making it unable to deploy staples. […]
Medical device recalls significantly increase during Q1
The medical device and pharmaceutical industries saw a significant spike in product recalls during the first quarter of 2018, according to the U.S. Recall Index released by Stericycle Expert Solutions. There was a 126% increase in medical device recalls in Q1 — the most in a quarter since 2005. Software problems made up about 22.7% […]
Stryker wins expanded CE Mark for Trevo stent retriever
Stryker (NYSE:SYK) said today that it won an expanded CE Mark indication in the European Union for its Trevo thrombectomy device as a front-line treatment for acute ischemic stroke patients for up to 24 hours from symptom onset. The expanded indication lifts the previously cleared treatment window by 18 hours, according to the Kalamazoo, Mich.-based company, and […]
CardioFocus wins FDA nod for HeartLight AF balloon
CardioFocus said today it won FDA approval for its HeartLight Excalibur balloon designed to treat paroxysmal atrial fibrillation. The Marlborough, Mass.-based company said that the newly cleared balloon uses technology from its HeartLight endoscopic ablation system alongside a new feature set intended to improve speed and magnitude of tissue contact during pulmonary vein isolation procedures. “We […]
FDA chief suggests kickback laws could be used to rein in drug prices
Drug rebates paid between pharmaceutical companies and pharmacy benefit managers enjoy safe harbor status under federal kickback law, leaving them immune from legal scrutiny. But that could change, FDA chief Dr. Scott Gottlieb suggested yesterday at the FDA Law Institute’s annual meeting. The commissioner reportedly hinted that reinterpreting the law could help lower drug prices. […]
Abbott wins FDA nod for Advisor HD Gridcardiac mapping cath
Abbott (NYSE:ABT) said today it won FDA clearance for is Advisor HD Grid mapping sensor enabled catheter designed for creating highly detailed maps of the heart. The newly cleared mapping catheter builds on the Abbott Park, Ill.-based company’s previous designs and and is intended to improve cardiac ablation procedures by providing an inside view of the heart […]
Report: FDA plans reorganized “super office” for device regulation
The FDA is planning a new “super office” for its Center for Devices and Radiological Health department and the soon-to-be created Office of Product Evolution and Quality, according to a Regulatory Affairs Professionals Society report. The new office will aim to support a new dynamic and overcome existing separations of functionality within the FDA to […]