Things seem to be happening all the time in the medical device industry. Whether it’s M&As, product launches, FDA approvals, or recalls, there’s never a dull moment. In light of the fact that every week seems to be equally or even more thrilling than the previous, we have decided to start sharing weekly round-ups where we discuss some key events that took place over the previous week. This edition covers Dexcom’s predicted 20% total revenue growth in 2023, GE Healthcare’s acquisition of IMACTIS, and why many are rethinking 510(k) clearances. This week’s most interesting insights can be found below.
Retrieved from: https://investors.dexcom.com/overview/default.aspx
Dexcom: 2023 Outlook
On January 9th, 2023, Dexcom released a press release summarizing preliminary earnings for 2022 and predicting growth in 2023. Compared to 2021, 2022’s unaudited preliminary revenue reached $2.91B, which was 19% higher (1). Following a similar trajectory, Dexcom anticipates that in 2023 the company should generate anywhere from $3.35B to $3.49B with 15%-20% expected growth (1). According to Dexcom, its G7 continuous glucose monitor (CGM) should support this growth in the U.S. and internationally, upon release. In December of 2022, Dexcom announced that its G7 continuous glucose monitor had received FDA approval and plans to launch this new device in early 2023. In the past, Dexcom has maintained a leading position within the continuous glucose monitoring market and held the dominant leading position in the personal CGM market, primarily attributed to the strong performance of the G6®.
Retrieved from: https://www.imactis.com/en/
GE Healthcare Announces Acquisition of IMACTIS
Similarly, on January 9th, 2023, GE Healthcare announced their plans to acquire IMACTIS, a France-based company that was founded in 2009. IMACTIS is an innovative player in the computed tomography (CT) interventional guidance field, making it very attractive to GE Healthcare. In terms of product offerings, IMACTIS states that its CT-Navigation™ “enables healthcare professionals to reach the target organ or lesion, with improved accuracy and speed, and with reduced radiation, which have been consistently identified as key unmet needs worldwide in percutaneous (skin piercing) interventional radiology (2).” As a leading global medical technology healthcare company, GE Healthcare is able to strengthen its portfolio with the acquisition of IMACTIS and the company’s CT interventional guidance product.
Retrieved from: https://www.regdesk.co/what-is-a-510k/
501(k) Clearance and Recalls
When it comes to medical devices entering the US market, most choose the 510(k) regulation pathway. During this process, manufacturers must demonstrate that their devices are equal to at least one current predicate product. A predicate product is essentially one that is legally allowed to be marketed in the US and can be used as a point of comparison for other products attempting to get premarket clearance. Recently, studies have been released that have uncovered the facts that between 2003 and 2018, there has been a significant association between 510(k) submission characteristics and device recalls (3). Essentially, they discovered that those who cited a predicate medical device with 3 or more ongoing recalls had approximately a 9% increase in recall probability relative to the mean (3). So far, only a few studies have started investigating the 510(k) clearance pathway. Therefore, before large conclusions are made further research is required to fully understand the implications.
In Summary
In the MedTech industry, things seem to have moved quickly after the holidays. With exciting 2023 predictions, promising acquisitions, and new insights into 510(k) clearance pathways, we are eager to see what lies ahead.
(3) Everhart AO, Sen S, Stern AD, Zhu Y, Karaca-Mandic P. Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance. JAMA. 2023;329(2):144–156. doi:10.1001/jama.2022.22974
