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July 14, 2022

June 2022 saw a 20% drop in medical devices’ approval in the US

By Carmen

The number of medical devices gaining approval in the US in June 2022 saw a 20% decrease when compared with May 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.

Hospital Supplies led newly approved devices in June 2022

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

As for the US medical devices market value, the Hospital Supplies market held a 14% share worth $23bn in 2021 and is expected to reach $22.97bn by 2023.

 

510(k) approved medical devices dominate the US market

In June 2022, the number of new medical devices entering the US market saw a 20% decrease when compared with May 2022.

GlobalData’s database indicated that 510(k) approved medical devices entering the US market, accounted for 96% of new medical devices in June 2022, compared with 94% in the previous month.

EUA declined by 56% in June 2022, as against 3% in May 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 June 2022

During June 2022, Class II medical devices entering the market accounted for 90% of new medical devices approved in June 2022, compared with 86% in May 2022. Class I devices decreased from 10% of new device approvals in May 2022 to 8% in June 2022.

Orthopedic Devices constituted the largest group of Class II devices, accounting for 12% of devices. Anesthesia and Respiratory Devices topped Class III approvals at 20%. 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 June 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 June 2022, while institute-developed marketed products held the remaining share.

In comparison, May 2022 saw a split of 99% in newly approved devices originating from private and public companies and 1% 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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