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Medtronic's (MDT) GI Genius Module Gets FDA De Novo Clearance

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Medtronic Plc (MDT - Free Report) recently announced receipt of the FDA de novo clearance for GI Genius intelligent endoscopy module in the United States. This latest development will expand Medtronic’s capabilities in medical technology data analytics and insights.

For investors’ note, GI Genius module was originally developed and is still manufactured by Cosmo Pharmaceuticals while Medtronic is the exclusive worldwide distributor. The GI Genius module is also available in Europe and select markets in Asia, Australia and the Middle East, in addition to the United States.

GI Genius Module at a Glance

The GI Genius module uses advanced artificial intelligence (“AI”) to emphasize the presence of precancerous lesions with a visual marker in real time – serving as a second observer. The device processes images using advanced algorithms that can spot and mark abnormalities consistent with polyploid, including even small flat polyploids that might get missed by the human eye.

Notably, the addition of AI in the GI Genius module can enhance the quality of colonoscopies, potentially improving diagnosis and outcome for colon cancer patients.

Study Findings

The study performed using GI Genius module confirmed a 14% absolute increase in adenoma detection rate compared to colonoscopy alone, thereby increasing accuracy and reducing the rise of interval cancers which can occur between colonoscopies.

Studies also verified that having a second observer can increase polyploid detection rates. Every 1% increase in adenoma detection rate reduces the chances of colorectal cancer by 3%.

Significance of the Approval

Per personnel associated with Medtronic, receipt of the FDA de novo clearance for the GI Genius module and the added AI capabilities will enhance and improve colonoscopies and polyploid detection. With the introduction of AI technology into the colonoscopy market, Medtronic foresees improvement in colonoscopy detection rates and decrease in variability of patient outcomes.

Industry Prospects

Per the Market Data Forecast report, the global colorectal cancer market size was valued at $15.3 billion in 2020 and is expected to reach $17.4 billion by 2025 at a CAGR of 2.63%.

Considering the market growth, the recent development by Medtronic to detect colorectal cancer is well timed.

Recent Developments

Medtronic has been witnessing positive development across its business segment with a slew of regulatory approvals of late.

In March 2021, Medtronic received the FDA’s approval for its Harmony Transcatheter Pulmonary Valve. The Harmony TPV is placed inside a patient's native anatomy during a catheter-based procedure. It was designated as a Breakthrough Therapy under FDA's Breakthrough Device Designation program.

During the same month, Medtronic announced receipt of the FDA’s approval for its revised commercial labeling for the Intellis Platform with Differential Target Multiplexed programming for the treatment of chronic, intractable back and leg pain. 

Price Performance

Shares of the company have gained 20.3% in a year’s time compared with the industry’s growth of 19.6%.

Zacks Rank and Key Picks

Currently, Medtronic carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the broader medical space are Owens & Minor, Inc. (OMI - Free Report) BioRad Laboratories, Inc. (BIO - Free Report) and LeMaitre Vascular, Inc. (LMAT - Free Report) . While Owens & Minor sports a Zacks Rank #1 (Strong Buy), BioRad Laboratories and LeMaitre Vascular carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Owens & Minor has a projected long-term earnings growth rate of 15%.

BioRad Laboratories has a projected long-term earnings growth rate of 7%.

LeMaitre Vascular has an estimated long-term earnings growth rate of 10%.

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