The number of medical devices gaining approval in the US in October 2022 saw a flat growth when compared with September 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 October 2022

Looking at the device sectors, Cardiovascular Devices held the largest share of 26% in gaining US approval during October 2022, followed by Hospital Supplies with 14% and Orthopedic Devices with 14%.

As for the US medical devices market value, the Cardiovascular Devices market held a 14% share worth $24.21bn in 2021 and is expected to reach $26.14bn by 2023.


510(k) approved medical devices dominate the US market

In October 2022, the number of new medical devices entering the US market saw a a flat growth when compared with September 2022.

GlobalData’s database indicated that 510(k) approved medical devices entering the US market, accounted for 64% of new medical devices in October 2022, compared with 59% in the previous month.

PMA declined by 35% in October 2022, as against 40% in September 2022.


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

During October 2022, Class II medical devices entering the market accounted for 59% of new medical devices approved in October 2022, compared with 55% in September 2022. Class III devices decreased from 41% of new device approvals in September 2022 to 35% in October 2022.

Orthopedic Devices constituted the largest group of Class II devices, accounting for 13% of devices. Cardiovascular Devices topped Class III approvals at 22%. 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 October 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 October 2022, while institute-developed marketed products held the remaining share.

In comparison, September 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.