This article - the second in a two-part series - examines the impact of a border adjustment and a border tariff on medical device companies, as well as the dynamics between the U.S., Mexico, and China.
Given that Republicans hold only a simple majority in the Senate, it is expected that their power to dismantle the ACA will be limited to those provisions that are tied to the budget. This article — the first in a two-part series — will discuss how repealing certain parts of the ACA will impact the medtech industry.
If you’re trying to decide whether to hire a product development firm, or determine which one is best for your needs, the key questions you should ask establish a checklist to make sure the firm follows best practices, and reveals more nuanced aspects of how the firm performs its work.
Thinking about flowers, candy, and cards? (If not, your Valentine’s Day may be in jeopardy.) While you’re thinking, why not explore some good news for the traditional Valentine symbol, the heart?
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, ensuring that patients and providers can rely on the output to make appropriate medical decisions.
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.
The Advanced Medical Technology Association (AdvaMed) is proposing two new safe harbors to the federal anti-kickback statute that aims to protect value-based pricing arrangements and value-based warranties.
Velano Vascular announced that the company has secured a third FDA 510(k) clearance for its next-generation design of PIVO, a device that can collect blood samples through peripheral intravenous (IV) lines, preventing additional and unnecessary needle sticks for hospitalized patients.
Nokia is relaunching the entire Withings portfolio of digital health devices this summer under the Nokia brand, the company announced at the Mobile World Congress (MWC) in Barcelona.
Announces Fourth Quarter and Full Year 2016 Financial Highlights, including Record Revenue and $133.2 million in Backlog ViewRay, Inc. (Nasdaq: VRAY) announced today that the company received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the MRIdian Linac system, the company's next generation linear accelerator-based MRI-guided radiation therapy system.
Royal Philips, a global leader in health technology, recently announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ElastQ Imaging capability, further expanding the functionalities of its EPIQ family of ultrasound systems.
Johnson & Johnson recently announced it has completed the acquisition of Abbott Medical Optics (AMO), a wholly-owned subsidiary of Abbott. The all-cash $4.325B acquisition was originally announced Sept. 16, 2016, and includes ophthalmic products in three areas of patient care: cataract surgery, laser refractive surgery and consumer eye health.
Cagent Vascular, a developer of next generation technology for vessel dilatation in cardiovascular disease interventions, announces FDA 510(k) Clearance of its lead product, the Serranator Alto PTA Serration Balloon Catheter.
The Council of the European Union has completed the final versions of its long-awaited Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR), which update the regulatory framework for the marketing of medical devices and in vitro diagnostics in Europe, the world’s second-largest device market.