Within the U.S. market alone, there are over 200,000 different types of medical devices which are manufactured over a broad range of global facilities. The FDA and its Center for Devices and Radiological Health (CDRH), whose goal is to protect and promote public health through safe and effective medical devices, has an extensive number of employees whose sole focus surrounds the oversight of new medical devices. On average, the FDA and the CDRH handle more than 20,000 submissions each year and review over a million medical device reports. Despite the extensive efforts exerted, these practices are essential for the U.S. supply chain and the U.S. healthcare system as a whole.
One of the programs developed by the FDA is the Devices Program. Essentially, the Devices Program is responsible for the regulation and oversight of a wide range of medical devices and radiation-emitting products that patients and their health care providers rely on daily. In order to ensure that manufacturers have a complete understanding of the requirements for devices to come to market in the U.S., the Devices Program applies a total product lifecycle approach. As of 2022, two companies have been able to achieve and receive FDA approval for two very different medical devices. These companies are Nevro Corporation and Cochlear Americas.
What is Nevro Corporation and Cochlear Americas?
Nevro Corporation, based in California, is a medical device company with a focus on relieving chronic pain within the trunk and/or limbs. Currently the company offers a variety of devices which utilize a next generation approach and offer spinal cord stimulation (SCS) without paresthesia. In the past, Nevro has received CE mark approval, TGA approval, and FDA approval for the company’s devices. (1)
On the other hand, Cochlear Americas is a medical device company based out of Colorado. Cochlear Americas has a strong focus on implantable hearing solutions and offers a range of products and accessories designed to assist in selecting the best, and most personalized option for every individual. (2)
Which Device Did Nevro Corporation Get Approval for?
(all information retrieved from: https://www.fda.gov/medical-devices/recently-approved-devices/senza-spinal-cord-stimulation-scs-system-p130022s042)
Nevro Corporation received FDA approval for its Senza Spinal Cord Stimulation (SCS) System. The Senza Spinal Cord Stimulation (SCS) system is an implanted, rechargeable spinal cord stimulation system intended to treat long-term (chronic) pain in the trunk or limbs that is difficult to manage. Nevro Corporation’s Senza device includes an implanted signal generator connected to either one or two implanted leads. Additionally, the device comes with a remote control that can turn the stimulator on and off to adjust the settings.
In order for the Senza SCS device to work, the implanted signal generator receives radio signals from the remote control. These signals then go on to tell the signal generator when it should deliver stimulation to the spinal cord. One benefit of the external remote control is that it is battery operated and can be controlled by either the patients or a healthcare provider. When programmed to 10 kHz, the Senza device is used to aid chronic pain in the trunk, limbs, or lower back in patients who have previously not received back surgery and are not candidates for future back surgery.
If you find yourself interested in the U.S. Spinal Devices market, iData offers updated reports on the Spinal Implants and Minimally Invasive Spinal Implants market reports which include procedures, ASPs, COVID-19 updates, and more. (3)
Which Device Did Cochlear Americas Get Approval for?
(all information retrieved from: https://www.fda.gov/medical-devices/recently-approved-devices/nucleus-24-cochlear-implant-system-p970051s205)
Cochlear Americas, on the other hand, received FDA approval for the Nucleus 24 Cochlear Implant System. The Nuclear 24 Cochlear Implant System is an implant that directly stimulates the auditory nerve, allowing patients to have access to sound. This device consists of both an internal and an external component.
The internal component of the Nucleus 24 Cochlear Implant System is implanted by a surgeon in the ear of a patient with single-sided deafness/unilateral hearing loss (SSD/UHL). Following implantation, a microphone in the external component picks up the sounds from the environment and turns it into digitally processed signals that are sent to the internal component. From here, the internal component sends electrical pulses to the cochlea in the inner ear after receiving the signals from the external device. These electrical pulses then go on to travel along the auditory nerve until they reach the brain where they are interpreted as sound.
In terms of what the Nucleus 24 Cochlear Implant System accomplishes, it may improve the patients understanding of speech in noise, and may assist in the patient’s ability to identify the location of sounds in direction. (4)
In addition to the two incredible devices which have already received FDA approval in 2022, the FDA and the Devices Program have been at the forefront of facilitating responsible adoption of Artificial Intelligence (AI) technologies. AI technologies are set to be the pioneers of innovation in 2022 and the FDA has already approved some AI/ML software as medical devices. Successful development of digital health technologies powered by AI is designed to inform the physical, cognitive, and psychological characteristics of the design of medical devices including software as a medical device for human use. (5)
With the Senza SCS, the Nuclear 24 Cochlear Implant System, and the advancements of AI technologies within the MedTech space, we are excited to see all of the innovative medical devices that will receive FDA approval in 2022 and what the future has in store.