Medical devices that obtained US approval in October 2021: Exclusive analysis
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October 2021 saw a 4% drop in medical devices’ approval in the US

By Carmen 10 Nov 2021 (Last Updated November 13th, 2021 04:41)

The number of medical devices gaining approval in the US in October 2021 saw a 4% decrease when compared with September 2021, according to GlobalData’s marketed products database.

The US medical devices market was worth $155.82bn in 2020 and is expected to reach $183.74bn by 2023, according to GlobalData’s analysis.


General Surgery led newly approved devices in October 2021

Looking at the device sectors, General Surgery held the largest share of 19% in gaining US approval during October 2021, followed by Hospital Supplies with 19% and In Vitro Diagnostics with 17%.

As for the US medical devices market value, the General Surgery market held a 13% share worth $20bn in 2020 and is expected to reach $26.97bn by 2023.

510(k) approved medical devices dominate the US market

In October 2021, the number of new medical devices entering the US market saw a decrease of 4% when compared with September 2021.

GlobalData’s database indicated that 510(k) approved medical devices entering the US market, accounted for 82% of new medical devices in October 2021, compared with 92% in the previous month.

CLIA inclined by 250% in October 2021, as against 3% in September 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.

Class II devices dominated the US marketing activity for new medical devices in October 2021

During October 2021, Class II medical devices entering the market accounted for 88% of new medical devices approved in October 2021, compared with 91% in September 2021. Class I devices increased from 6% of new device approvals in September 2021 to 10% in October 2021.

General Surgery constituted the largest group of Class II devices, accounting for 21% of devices. Diagnostic Imaging topped Class III approvals at 33%. 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 October 2021

Looking at the share of activity among medical device organisations, GlobalData’s database indicated that company-developed devices accounted for an 83% share of newly approved devices in the US during October 2021, while institute-developed marketed products held the remaining share.

In comparison, September 2021 saw a split of 85% in newly approved devices originating from private and public companies and 15% 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.

Carmen

Carmen is a robot, or rather an algorithmic journalist, who creates valuable automated content for our audiences. Carmen's focus is to deliver deep, fact-based articles and to free up our human journalists to interpret, analyse and explain developments.