Siemens Healthineers (NYSE:SI) said today that its Atellica Solution won CE Mark and that the advanced diagnostic system is now available in Europe, the U.S., South America and Asia. The system consists of scalable immunoassay and chemistry analyzers, the company said, and can operate as a stand-alone system or connect to Aptio Automation. Get the full […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Boston Scientific launches MRI-safe Resonate devices with HeartLogic diagnostic in U.S.
Boston Scientific (NYSE:BSX) launched today its Resonate implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator systems with the HeartLogic heart failure diagnostic tool. The devices are approved by the FDA for conditional use in an MRI environment, the company reported. Boston Scientific’s HeartLogic diagnostic warns doctors of worsening heart failure, collecting data from sensors monitoring heart […]
Amedica plans 510(k) submission for new cervical implant in Oct, touts Q1, Q2 prelim earnings
Amedica (NSDQ:AMDA) said today that after a 510(k) pre-submission meeting with the FDA, it is on track to submit a 510(k) application for a modified porous cervical implant next month, and announced preliminary earnings for its 1st and 2nd quarters. The company said it is entering the beta launch of its Taurus pedicle screw system which […]
7 medtech stories we missed this week: Sept. 22, 2017
From the FDA’s clearance of Covalon’s film-drape to Bioventus launching its study, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Covalon’s MediClear OTC surgical film-drape Covalon announced in a Sept. 21 press release that the FDA has cleared its MediClear PreOp to market in U.S. hospitals, […]
How Abbott is making good on investor promises
Abbott (NYSE: ABT) has won FDA approval of MR-compatible ICDs – an indication that it could be making good executing on key priorities it inherited when it acquired St. Jude Medical for $25 billion early this year. The news today “lends incremental credibility to our thesis that ABT can and will have a positive impact on STJ […]
Clinical trials system is ‘broken’, FDA’s Woodcock says
The clinical trials system is “broken,” according to the director of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock. The system needs new clinical trial networks and the adoption of mater protocols – protocols for trials that focus on multiple therapies for a single disease or a single treatment that could apply to […]
Abbott wins MR-conditional label for Ellipse ICDs
Abbott (NYSE:ABT) said today that it won an MR-conditional label from the FDA for the Ellipse implantable cardioverter defibrillator it acquired along with St. Jude Medical early this year. The MR-conditional label applies to Ellipse and the Tendril MRI pacing lead and the Durata and Optisure high-voltage leads, the Chicago-area medical device giant said. “When […]
Brainlab wins FDA nod for Elements Spine, Cranial SRS radiosurgery planning software
Brainlab said today it won FDA clearance for its Elements Spine SRS and Elements Cranial SRS radiosurgery surgical planning software applications. The Munich, Germany-based company said that the Elements Cranial SRS is designed to allow physicians to create radiosurgery plans in less than 15 minutes, supporting plans for numerous cranial indications including arteriovenous malformations, pituitary […]
Endologix wins refined CE Mark indications for Nellix stent graft
Endologix (NSDQ:ELGX) said today it won expanded CE Mark approval in the European Union for its Nellix endovascular aneurysm sealing system with refined indications for use. The Irvine, Calif.-based company said that the refined indications for use were supported by clinical data and an independent clinical reviewer, and that the device met applicable safety and clinical […]
FDA chimes in on off-label use, preemption in Smith & Nephew hip suit
The FDA last week chimed in on a lawsuit brought against Smith & Nephew (NYSE:SNN) by a patient whose surgeon used the company’s hip implants off label, arguing that federal law preempts most tort claims even when medical devices are used outside of their indications. Plaintiff Walter Shuker was implanted with components from Smith & Nephew’s […]
Indian gov’t mulls price cap on ‘essential’ medical devices
The Indian government is considering capping prices on medical devices it deems essential to health care, according to a new report from LiveMint. The government has assembled a committee to create a National List of Essential Medical Devices which it intends to make available with assurances related to both quality and price, according to the […]