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Plenity: A Device For Weight Loss that Looks Like A Drug, And Is Sold Like A Consumer Product

 
• By Barnaby Pickering

Medtech Insight spoke to the chief executive and chief operating officers of Plenity’s manufacturer, Gelesis, to learn more about its weight loss device.

Plenity Capsules • Source: Gelesis

Gelesis is trying to make weight-loss intervention safe and effective for a wider range of patients than are addressed by current technologies.

Over 70% of the American adult population are overweight or obese and this number is growing. The issue is also global, with obesity levels rising in almost every nation, particularly those in the west and those that are rapidly developing

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SS Innovations Files For De Novo For SSi Mantra 3 Surgical Robotic System For Multispecialty Indications

 
• By Marion Webb

SS Innovations announced plans to file a de novo application with the US FDA for its SSi Mantra 3 surgical robot, already approved for marketing in six countries. The Florida-based firm also plans to pursue the CE mark for European commercialization.

Consumer Healthtech Investment Totaled $4.5BN In 2024, But Bar Is High Amid Economic Uncertainty

 
• By Marion Webb

Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.

‘Preparing For Regulatory Milestones, Commercial Launch’ Are Priorities, Says New Freenome CEO Aaron Elliott

 
• By Marion Webb

Freenome plans to file for US FDA approval of its blood-based screening test for colorectal cancer mid-year. If cleared, the test would rival Guardant Health’s Shield, the first FDA-cleared blood test for primary screening of colorectal cancer. Exact Sciences is also in the race to bring a blood-based colorectal screening test to market.

What’s The Scope Of Endoscope Risk?

 
• By Brian Bossetta

For the fourth time in as many years the FDA has issued a communication concerning a key accessory from Olympus used in several types of urological procedures. This time, however, the agency has added a class I recall confirmation to its original early alert on the device issued in December 2024. A device safety specialist provided Medtech Insight with a deeper understanding of the problem as well as overall scope safety.

More from Device Area

SS Innovations Files For De Novo For SSi Mantra 3 Surgical Robotic System For Multispecialty Indications

 
• By Marion Webb

SS Innovations announced plans to file a de novo application with the US FDA for its SSi Mantra 3 surgical robot, already approved for marketing in six countries. The Florida-based firm also plans to pursue the CE mark for European commercialization.

The Value Of Consumer Wearables Within The Clinic Is Currently Unknown, Says Cardiologist

 
• By Natasha Barrow

“It’s quite likely [consumer wearable manufacturers] are changing the sensitivity and specificity based on consumer feedback, but not for medical reasons,” said Dipak Kotecha, a University of Birmingham professor of cardiology. Often, self-reported performance evidence from manufacturers is “low quality and biased.”

Beyond The Bladder: Incontinence Impacts Mental Health

 
• By Brian Bossetta

In recognition of Mental Health Awareness month, Sarah Jenkins, executive director at the National Association for Continence, discussed the mental health issues that often come with incontinence.