Back to top

Image: Bigstock

Medtronic's (MDT) PillCam SB3 System Gets 510 (k) Clearance

Read MoreHide Full Article

Medtronic plc (MDT - Free Report) recently announced the receipt of the FDA 510 (k) clearance for its PillCam Small Bowel 3 @HOME (SB3) system for remote endoscopy procedures. The latest approval for PillCam further allows patients to get gastrointestinal care in the comfort of their homes.

It is worth mentioning that PillCam Small Bowel 3 @HOME is only approved for remote use in the United States.

The recent approval will fortify Medtronic’s gastrointestinal business, which is part of the company’s Medical Surgical Portfolio.

More on PillCam SB3 System

PillCam SB3 @HOME offers a telehealth option for direct visualization and monitoring of the small bowel to help detect lesions in a better way which is otherwise not detected by upper and lower endoscopy.

The PillCam SB3 @HOME program merges Medtronic's PillCam technology with Amazon logistics -- a combination designed to ensure both timely and accurate results for patients from the comfort of their homes.

The PillCam SB3 system is intended to deliver images of the mucosa and provides advanced features, such as adaptive frame rate technology. The advanced features support image acquisition that is well suited to each patient's motility as well as the tools needed to record those images and enable the clinician to interpret study results. The system’s advanced technology helps providers read and interpret study results efficiently.

Significance of the PillCam SB3 System

Per Medtronic’s management, the COVID-19 pandemic necessitated more remote innovation, and the company’s capabilities have exceeded expectations to offer better quality care to patients without the risk of COVID-19 infection and without adding to the burden on the medical staff.  PillCam SB3 @HOME provides a convenient option for a contactless procedure and helps ensure that patients access care in a timely manner.

Zacks Investment ResearchImage Source: Zacks Investment Research

The PillCam SB3 system enables patients to remain in the comfort and safety of their homes while offering healthcare providers access to high-quality images needed to make a diagnosis efficiently.

Recent Developments

In October 2021, Medtronic announced the receipt of CE Mark approval for its Hugo robotic-assisted surgery (RAS) system, authorizing the sale of the system in Europe. With the CE Mark approval, multiple hospitals across Europe are set to be the first to install Hugo RAS system and expand the benefits of robotic-assisted surgery to their patients.

In the same month, Medtronic announced that the first clinical procedure was performed with the Hugo robotic-assisted surgery (RAS) system in the Asia-Pacific region. The robotic prostatectomy was performed at Apollo Hospitals in Chennai, India.

Industry Prospects

Per a report by Allied Market Research, the global endoscopy devices market size was valued at $31.78 billion in 2019 and is projected to reach $43.82 billion by 2027, at a CAGR of 4.1%.

Technological advancements in endoscopes that can be used for early detection of diseases and the rise in the incidence of diseases requiring endoscopy devices are driving the market.

Price Performance

Shares of the company have gained 6.7% in a year’s time against the industry’s fall of 0.3%.

Zacks Rank and Key Picks

Medtronic currently carries a Zacks Rank #4 (Sell).

A few better-ranked stocks from the broader medical space are Thermo Fisher Scientific Inc. (TMO - Free Report) , Laboratory Corporation of America Holdings, or LabCorp (LH - Free Report) and Medpace Holdings, Inc. (MEDP - Free Report) .

Thermo Fisher Scientific, carrying a Zacks Rank #2 (Buy), reported third-quarter 2021 adjusted earnings per share (EPS) of $5.76, which surpassed the Zacks Consensus Estimate by 23.3%. Revenues of $9.33 billion outpaced the Zacks Consensus Estimate by 12%.

Thermo Fisher has an estimated long-term growth rate of 14%. TMO surpassed estimates in the trailing four quarters, the average surprise being 9.02%.

LabCorp reported third-quarter 2021 adjusted EPS of $6.82, which surpassed the Zacks Consensus Estimate by 42.9%. Revenues of $4.06 billion outpaced the Zacks Consensus Estimate by 13.4%. It currently carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

LabCorp has an estimated long-term growth rate of 10.6%. LH surpassed estimates in the trailing four quarters, the average surprise being 25.7%.

Medpace reported third-quarter 2021 adjusted EPS of $1.29, surpassing the Zacks Consensus Estimate by 20.6%. Revenues of $295.57 million beat the Zacks Consensus Estimate by 1.2%. It currently carries a Zacks Rank #1.

Medpace has an estimated long-term growth rate of 16.4%. MEDP company surpassed estimates in the trailing four quarters, the average surprise being 11.9%.

Published in