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Home News Durham medtech startup Deep Blue receives FDA clearance for hernia mesh product

Durham medtech startup Deep Blue receives FDA clearance for hernia mesh product

Medtech startup Deep Blue Medical Advances can now begin selling a novel hernia mesh product with enhanced anchoring strength following receipt of FDA device (501 K) clearance, which the company announced it had received Tuesday.

The T-Line Hernia Mesh “provides superior anchoring strength and eliminates a key point of failure for conventional mesh fixation,” the Durham-based company says. It is designed to counter “mesh migration, contraction and eventual failure.”

Deep Blue has raised more than $800,000 in funding.

The company was founded in 2014 by Duke plastic surgeon Howard Levinson, MD.

Millions of hernia surgeries are done globally at billions in clinical costs and support a $1.1 billion hernia device market.

In separate efforts, Levinson is working on additional  projects including an anti-biofouling Foley catheter, a non-invasive light imaging technology to diagnose skin disorders, and tissue-engineered skin that resists contraction.

“Sewing a bit of each extension into the abdominal wall, in lieu of traditional sutures, significantly increases mesh anchoring strength and thus the durability of the repair,” Levinson says of the T-Line. “We believe this approach will greatly improve patient outcomes without necessitating significant changes to current surgical practice.”

The firm says it plans to launch the T-Line at “selected sites” in the near future.


Read the full story here

[Originally posted by WRALTechWire — Aug 11, 2020]

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