The number of medical devices gaining approval in the US in August 2022 saw a 4% decrease when compared with July 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 August 2022
Looking at the device sectors, Hospital Supplies held the largest share of 18% in gaining US approval during August 2022, followed by Orthopedic Devices with 12% and Dental Devices with 11%.
As for the US medical devices market value, the Hospital Supplies market held a 14% share worth $23.69bn in 2021 and is expected to reach $22.97bn by 2023.
510(k) approved medical devices dominate the US market
In August 2022, the number of new medical devices entering the US market saw a 4% decrease when compared with July 2022.
GlobalData’s database indicated that 510(k) approved medical devices entering the US market, accounted for 94% of new medical devices in August 2022, compared with 92% in the previous month.
PMA inclined by 67% in August 2022, as against 2% in July 2022. 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 August 2022
During August 2022, Class II medical devices entering the market accounted for 89% of new medical devices approved in August 2022, compared with 91% in July 2022. Class I devices decreased from 7% of new device approvals in July 2022 to 6% in August 2022.
Hospital Supplies constituted the largest group of Class II devices, accounting for 15% of devices. In Vitro Diagnostics topped Class III approvals at 60%. 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 August 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 August 2022, while institute-developed marketed products held the remaining share.
In comparison, July 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.