The definition of a medical device in the Federal Food, Drug and Cosmetic Act (FDCA) is purposefully broad — some say too broad. It allows the FDA to reserve potential oversight of many healthcare products, including software, and some software development companies have bristled at the FDA’s potential to regulate their products.
A one percent failure rate should be unacceptable in any industry, especially healthcare. More aggressive and smarter testing will, in essence, cut that current failure rate in half.
This article summarizes insights gleaned from interviews with multiple consultants, each of whom has at least 25 years’ experience in the life sciences space — and from conversations with the life science companies who hire such consultants to ensure that their systems meet the product quality attribute/specification requirements mandated by their respective regulators.
While opioids are a quick fix to chronic pain, and the up-front costs of SCS far exceed the cost of an opioid prescription, SCS is a less dangerous and more effective treatment that will only become more clinically effective with further product improvements.
Often, an already-approved drug can further benefit patients when applied with a medical device. In such cases, the pharmaceutical product sponsor may utilize the 505(b)(2) pathway for regulatory approval of the combination product. But even when the regulatory pathway is known, submission strategies for regulatory approval of combination products can be challenging and confusing. The development and review of combination products in the U.S. typically requires the involvement of multiple centers within the Food and Drug Administration (FDA), under the oversight of the FDA’s Office of Combination Products (OCP).
To enter the rapidly growing mobile health space, companies must overcome the Mobile Health Development-crucial hurdle of validation. This process demonstrates that the app – in combination with the underlying technology platform / device – performs comparably to traditional products on the market..
Winning in the medical devices market of the future requires mastering advanced technologies – or finding a partner with these capabilities. The global Internet of Things (IoT) in healthcare market is forecasted to reach $410 billion by 2022. To succeed in this arena, device companies need to stay out in front of manufacturing innovations so they can quickly integrate information technology (IT) functionality into their products, accelerate time to market and control costs.
The best practice for fitting multiple parts into a single assembly at tight tolerances is to choose a single component supplier with a sufficient array of core competencies in advanced device manufacturing methods. The chosen supplier should also utilize a well-designed component management process that includes close attention to important elements, proper planning, and high performance levels to provide an affordable, highly scalable drug delivery device.
The in vitro diagnostics (IVD) market is commonly segmented by techniques, products, application, end users, and geography. To better navigate the IVD diagnostic market landscape, understanding and recognizing how each segment is distinct, yet related to one another is critical for the company that wants to optimize its opportunities within this market.
Exactech, Inc., a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip, announced recently it has received clearance from the U.S. Food and Drug Administration to market the ExactechGPS Shoulder Application
Novocure announced recently that United States Food and Drug Administration (FDA) has designated it’s Tumor Treating Fields (TTFields) delivery system as a Humanitarian Use Device (HUD) for the treatment of pleural mesothelioma.
Shockwave Medical, a pioneer in the treatment of calcified cardiovascular disease, recently announced conformité européenne (CE) Mark for the company’s Coronary Lithoplasty System for the treatment of calcified plaque in conjunction with stenting in patients with coronary artery disease.
The U.S. Food and Drug Administration today authorized use of the Flourish Pediatric Esophageal Atresia Anastomosis, a first-of-its-kind medical device to treat infants up to one year old for a birth defect that causes a gap in their esophagus, called esophageal atresia.
QT Vascular Ltd., (the "Company" or "QT Vascular", and together with its subsidiaries, the "Group"), a global company engaged in the design, assembly and distribution of advanced therapeutic solutions for the minimally invasive treatment of vascular disease, announced today that it has entered into an asset purchase option agreement ("Option Agreement") with Medtronic, for the acquisition of the Group's non-drug coated Chocolate® PTA.
Cook Medical is pleased to announce the sale of its comprehensive family of vertebroplasty products to IZI Medical Products, LLC.
Siemens Healthineers is joining forces with U.S.-based Imricor Medical Systems Inc. to develop an integrated solution that combines the clinical benefits of real-time MRI scans with 3D-guided cardiac ablation.
Medtronic plc has received U.S. Food and Drug Administration (FDA) approval for a portfolio of quadripolar cardiac resynchronization therapy-pacemakers (CRT-Ps) that improve therapy delivery for patients with heart failure.