Looking at the device sectors, Hospital Supplies held the largest share of 22% in gaining US approval during January 2022, followed by Orthopedic Devices with 12% and General Surgery with 12%.

As for the US medical devices market value, the Hospital Supplies market held a 13% share worth $22bn in 2021 and is expected to reach $21.94bn by 2023.

In January 2022, the number of new medical devices entering the US market saw a 33% decrease when compared with December 2021.

GlobalData’s database indicated that 510(k) approved medical devices entering the US market, accounted for 92% of new medical devices in January 2022, compared with 95% in the previous month.

CLIA inclined by 550% in January 2022, as against 1% in December 2021. CLIA 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.

During January 2022, Class II medical devices entering the market accounted for 94% of new medical devices approved in January 2022, compared with 85% in December 2021. Class I devices decreased from 13% of new device approvals in December 2021 to 6% in January 2022.

Hospital Supplies constituted the largest group of Class II devices, accounting for 16% of devices. 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.

Looking at the share of activity among medical device organisations, GlobalData’s database indicated that company-developed devices accounted for a 98% share of newly approved devices in the US during January 2022, while institute-developed marketed products held the remaining share.

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