MPO’s Most-Read Stories This Week—Nov. 12

Recalls, M&A, and personnel moves are usually popular news items, so it comes as no surprise that cybervisitors gravitated to these subject areas this past week on MPO’s website.

Gaining the most traction with digital guests was Insulet’s recall of all Omnipod DASH personal diabete managers (PDMs) distributed globally. The action was taken voluntarily last month with FDA and other regulatory agencies’ knowledge. Insulet received reports of PDM battery issues including battery swelling and leakage, and extreme overheating in rare cases that resulted in fires. The company’s investigation found the Omnipod DASH PDM has increased risk of malfunction if overcharged beyond the maximum voltage. Fifty complaints have been reported, with no serious injuries or deaths reported thus far. 

Anumana and Leica Biosystems drove website traffic with acquisition announcements, while J&J boosted pageviews with news of a new C-Suite executive.

Anumana (a portfolio company of nference) acquired NeuTrace, a company focused on in-procedure AI applications for electrophysiology (EP). The deal includes the NeuTrace EP Data Biome platform and portfolio of AI-enabled EP software applications in development. As part of the transaction, nference acquired rights to the Data Biome platform for uses outside of the cardiovascular field.
 
Leica Biosystems, meanwhile, purchased Cell IDx, a developer of multiplexed tissue profiling. Cell IDx provides multiplex staining panels, tissue staining, and imaging and analysis services. The company’s UltraPlex allows simultaneous detection of multiple biomarkers in many immunoassays via fluorescent and chromogenic multiplex immunohistochemistry (IHC) staining technology and automated chromogenic detection of multiple markers on Leica’s BOND RX fully automated research stainer. Together, the two technologies lets researchers detect three or more markers chromogenically on a single slide, with a straightforward pathology workflow.

Johnson & Johnson MedTech gained quite a following upon naming Ahmet Tezel, Ph.D., as company group chairman and Global Head of MedTech Innovation and R&D, following the retirement of Peter Shen, Ph.D. Tezel will be responsible for end-to-end aspects of research and development for Johnson & Johnson MedTech as the company makes its solutions smarter, less invasive, and more personalized. Ahmet will work with Shen before he retires at the end of the year to ensure a smooth transition.
Under Tezel’s leadership as Worldwide Vice President, R&D for Ethicon, the Ethicon R&D pipeline value increased over two-fold. He also played an integral role in creating synergies between Ethicon and the Robotics and Digital Solutions teams to enhance integrations of technology platforms and utilization of product development best practices. Tezel joined Johnson & Johnson with broad experience in the medical technology industry including a strong history of driving innovation strategy, delivering new products to market as well as retaining and advancing key talent. He is a Credo-based leader who is dedicated to developing people and creating an inclusive work environment.

ProciseDx generated website traffic, too, with the FDA clearance of its ProciseDx instrument and C reactive protein (CRP) test, which quantitatively determines CRP levels in patient serum in under five minutes. The company expects FDA clearance of further tests in 2024. Procise Dx has a menu of five-minute gastroenterology (GI) and therapeutic drug monitoring (TDM) tests available in Europe.

1. Insulet Recalls Omnipod DASH Personal Diabetes Managers

2. Anumana Acquires NeuTrace to Advance Electrophysiology Deep Learning

3. Leica Biosystems Acquires Cell IDx

4. Ahmet Tezel Named Global Head of MedTech Innovation and R&D at J&J

5. FDA OKs ProciseDx Instrument and C Reactive Protein Assay