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.
Among the dozen "A-List" guidance topics that FDA has slated for finalization in 2017, three already have been released. That's good progress. But, at least three of those guidance initiatives put forth directives that medical device companies may find difficult, if not impossible, to follow.
Government and private insurance health plans struggle for clarity when writing contracts for their members’ healthcare coverage. In each state, these contracts have to be filed and approved by the state departments of insurance and commerce. Is it any wonder there is a need for simplicity, clarity, and consistency in the services each state and private insurer covers?
Integron's president discusses how his company developed a growth strategy to approach companies with existing in-home therapies looking to connect their devices. The end result was remote patient monitoring and connected health offerings that have been deployed to 56 countries around the world.
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 Juvenile Diabetes Research Fund (JDRF) has invested in a long-lasting continuous glucose monitor (CGM) that uses engineered live cells to replenish and maintain the stability of the implant’s optical biosensor over time.
Ethicon, Inc. today announced a definitive agreement to acquire Torax Medical, Inc., a privately held medical device company that manufactures and markets the LINX® Reflux Management System, a novel minimally invasive device for the surgical treatment of GERD.
Medtronic's newest addition to its growing minimally-invasive surgery portfolio is the single-handed, powered Signia surgical stapler, which has the ability to sense human tissue thickness and automatically adjust stapling speed to achieve consistent staple lines.
FlowAid Medical Technologies (FlowAid), makers of non-invasive devices and therapies for circulatory disorders affecting extremities, have announced FDA approval for a calf muscle stimulation system that reduces incidence of blood clots and swelling.
Hologic, a manufacturer of diagnostics and women's health products, is moving into the burgeoning — but still underpenetrated — $2 billion medical aesthetics market by acquiring Cynosure, a leading maker of non-invasive body contouring, hair removal, and skin revitalization products.
Integra LifeSciences has agreed to purchase Johnson & Johnson (J&J) subsidiary Codman Neurosurgery for $1.05 billion, with plans to build a more comprehensive neurosurgery portfolio and expand its international foothold.
Medtronic plc recently announced the U.S. Food and Drug Administration (FDA) has approved its Freezor Xtra Cryoablation Catheter for treating patients with atrioventricular nodal re-entrant tachycardia (AVNRT), a life-threatening abnormal heart rhythm.
The number of patients under remote monitoring using interconnected devices jumped by 44 percent to 7.1 million in 2016, as patients and providers continue to realize the convenience and cost-efficiency of mHealth devices and applications, according to a report by Berg Insight.