The number of medical devices gaining approval in the US in September 2022 saw an 39% decrease when compared with August 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.


Diagnostic Imaging led newly approved devices in September 2022

Looking at the device sectors, Diagnostic Imaging held the largest share of 16% in gaining US approval during September 2022, followed by Hospital Supplies with 15% and Orthopedic Devices with 11%.

As for the US medical devices market value, the Diagnostic Imaging market held a 4.7% share worth $8.02bn in 2021 and is expected to reach $8.64bn by 2023.

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510(k) approved medical devices dominate the US market

In September 2022, the number of new medical devices entering the US market saw an 39% decrease when compared with August 2022.

GlobalData’s database indicated that 510(k) approved medical devices entering the US market, accounted for 86% of new medical devices in September 2022, compared with 61% in the previous month.

EUA declined by 50% in September 2022, as against 0.4% in August 2022. EUA have become more common during the COVID-19 pandemic, as a speedy mechanism to bring therapeutic devices to market more quickly than the usual device approval process.


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

During September 2022, Class II medical devices entering the market accounted for 80% of new medical devices approved in September 2022, compared with 59% in August 2022. Class III devices decreased from 38% of new device approvals in August 2022 to 12% in September 2022.

Diagnostic Imaging constituted the largest group of Class II devices, accounting for 20% of devices. Cardiovascular Devices topped Class III approvals at 35%. 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 September 2022

Looking at the share of activity among medical device organisations, GlobalData’s database indicated that company-developed devices accounted for a 99% share of newly approved devices in the US during September 2022, while institute-developed marketed products held the remaining share.

In comparison, August 2022 saw a split of 100% in newly approved devices originating from private and public companies and 1% 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.