The final FDA guidance on design consideration and pre-market submission for interoperable medical devices was released on September 6. The demand for these devices is increasing in the healthcare system as our dependence on more rapid and protected interactions between devices grows. This increase presents a need for a parallel increase in adequate FDA regulations for this elaborate device field.
The global medical sensors market is estimated to reach $15.01 billion by 2022, at a CAGR of 8.5% between 2016 and 2022. People are increasingly adopting home healthcare services owing to the rising costs of medical treatments in hospitals and medical care clinics. With this, the demand for various healthcare devices is expected to increase in the next few years.
Medical researchers are increasingly turning to mobile devices such as smartphones and watches as a way to monitor patients in trials, an approach they hope improves participation and accuracy but that also has limitations.
New technologies, therapies and medicines are emerging; this includes regenerative medicine, more personalised treatments, as well as the development of nanomedicines. The Commission is committed to monitoring scientific progress and to constantly review Community legislation in the light of new developments so as to make safe, novel treatments available to patients as early as possible.
More connected medical devices are coming online every day, reshaping the way that healthcare networks are designed, used and secured.
Perflow Medical, an Israeli-based medtech company focused on next-generation neurointerventional devices,announced the issuance of U.S. Patent No. 9510855, by the U.S. Patent and Trademark Office (USPTO), for the Stream™ Dynamic Neuro-Thrombectomy Net. This is the first device to provide full dynamic wall apposition during the treatment of acute ischemic stroke.
We’re no stranger to robotics in the medical field. Robot-assisted surgery is becoming more and more common. Many training programs are starting to include robotic and virtual reality scenarios to provide hands-on training for students without putting patients at risk.
Clinical development has historically been a laborious and expensive process that stretches across all therapeutic areas. It is driven by lengthy patient recruitment timelines, increasingly complex study designs, and high procedural costs. Depending on whose data you believe, getting a new drug to market can now cost upwards of $1 billion and take more than 10 years or research and development effort. Additionally, a complex and dynamic regulatory framework has made sponsors reluctant to introduce new technologies to facilitate the development process.
The US Food and Drug Administration (FDA) has announced new measures to promote medical device innovation and provide patients with fast access to beneficial technologies.
Johnson & Johnson Group world wide chair Sandi Peterson said: “At Johnson & Johnson Medical Devices Companies, we are committed to broadening our portfolio of products and services to meet the changing needs of our customers around the world.
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