The number of medical devices gaining approval in the US in November 2022 saw a 2% increase when compared with October 2022, according to GlobalData’s marketed products database.

The US medical devices market was worth $169.99bn in 2021 and is expected to reach $169.71bn by 2023, according to GlobalData’s analysis.

Cardiovascular Devices led newly approved devices in November 2022

Looking at the device sectors, Cardiovascular Devices held the largest share of 27% in gaining US approval during November 2022, followed by Orthopedic Devices with 11% and Hospital Supplies with 11%.

As for the US medical devices market value, the Cardiovascular Devices market held a 14% share worth $24.22bn in 2021 and is expected to reach $26.14bn by 2023.

510(k) approved medical devices dominate the US market

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

In November 2022, the number of new medical devices entering the US market saw a 2% increase when compared with October 2022.

GlobalData’s database indicated that 510(k) approved medical devices entering the US market, accounted for 59% of new medical devices in November 2022, compared with 60% in the previous month.

PMA inclined by 5% in November 2022, as against 39% in October 2022.

Class II devices dominated the US marketing activity for new medical devices in November 2022

During November 2022, Class II medical devices entering the market accounted for 56% of new medical devices approved in November 2022, compared with 55% in October 2022. Class III devices increased from 39% of new device approvals in October 2022 to 40% in November 2022.

Hospital Supplies constituted the largest group of Class II devices, accounting for 16% of devices. Cardiovascular Devices topped Class III approvals at 61%. Class III devices are devices that generally pose the most risk to patients and includes implantable devices. Class I devices are of a lesser risk.

Company-developed devices lead US regulatory approvals during November 2022

Looking at the share of activity among medical device organisations, GlobalData’s database indicated that company-developed devices accounted for a 100% share of newly approved devices in the US during November 2022, while institute-developed marketed products held the remaining share.

In comparison, October 2022 saw a split of 100% in newly approved devices originating from private and public companies and 0% from institutes.

The medical devices approval data used in this article were extracted from Medical Marketed Products Database of GlobalData’s Medical Intelligence Center. Marketed Products database covers all commercialized medical devices which are intended for diagnosis, treatment, and management of diseases/conditions/symptoms directly or indirectly. Marketed products are covered from regulatory bodies like US FDA, company websites, news releases, SEC filings etc. The information is collected by following systematic research techniques and proprietary methodology.