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January 11, 2022updated 19 Jan 2022 5:21am

December 2021 saw a 22% rise in medical devices’ approval in the US

By Carmen

The number of medical devices gaining approval in the US in December 2021 saw a 22% increase when compared with November 2021, according to GlobalData’s marketed products database.

The US medical devices market was worth $154.01bn in 2020 and is expected to reach $182.95bn by 2023, according to GlobalData’s analysis.

Hospital Supplies led newly approved devices in December 2021

Looking at the device sectors, Hospital Supplies held the largest share of 26% in gaining US approval during December 2021, followed by General Surgery with 11% and Orthopedic Devices with 11%.

As for the US medical devices market value, the Hospital Supplies market held a 17% share worth $26bn in 2020 and is expected to reach $21.94bn by 2023.

510(k) approved medical devices dominate the US market

In December 2021, the number of new medical devices entering the US market saw a 22% increase when compared with November 2021.

GlobalData’s database indicated that 510(k) approved medical devices entering the US market, accounted for 94% of new medical devices in December 2021, compared with 94% in the previous month.

PMA inclined by 2% in December 2021, as against 0% in November 2021. PMA 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 December 2021

During December 2021, Class II medical devices entering the market accounted for 85% of new medical devices approved in December 2021, compared with 91% in November 2021. Class I devices increased from 9% of new device approvals in November 2021 to 13% in December 2021.

Hospital Supplies constituted the largest group of Class II devices, accounting for 16% of devices. Cardiovascular Devices topped Class III approvals at 57%. 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 December 2021

Looking at the share of activity among medical device organisations, GlobalData’s database indicated that company-developed devices accounted for a 92% share of newly approved devices in the US during December 2021, while institute-developed marketed products held the remaining share.

In comparison, November 2021 saw a split of 95% in newly approved devices originating from private and public companies and 5% from institutes.

Methodology
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.

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