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BioWorld - Saturday, June 13, 2026
Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Oct. 5, 2017

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FDA: all combo products meet definition of a drug until proven otherwise

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Israel start up, Kaiser study uses AI to identify patients at high risk for colorectal cancer

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Crystal-clear images, no crystal required

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Daily M&A

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Financings

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Other news to note

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Product briefs

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Regulatory front

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BioWorld Medtech's Orthopedics Extra

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Edap Tms snags FDA clearance for Ablatherm-Fusion device used during prostate ablation

Edap Tms SA reported FDA clearance of its Ablatherm-Fusion device, a high intensity focused ultrasound (HIFU) technology that enables a method for the targeting of diagnosed areas within the prostate. The FDA's nod for the device comes on the heels of the Centers for Medicare and Medicaid Services (CMS) approval of a new code that could quite possibly lead to an increase in HIFU device adoption. Read More

Nexxt Spine wins FDA nod for Matrixx spinal system

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