Category Archives: Uncategorized

Electrical implants enable paralyzed man to move his limb in feasibility study

By Stacy Lawrence, Staff Writer Technology to enable paralyzed patients to move, and even to feel, their limbs is advancing apace. The latest progress comes from Case Western Reserve University researchers who have worked for months with a man with…

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Proposed law would restrict prosecution for off-label communication in U.S.

By Mark McCarty, Regulatory Editor With the off-label/intended use controversy still simmering, a bill has debuted in the U.S. House of Representatives that would restrict the federal government’s ability to pursue charges against manufacturers of drugs and devices based merely…

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EU Parliament votes into law regulations for IVDs, med devices

By John Brosky, Contributing Writer PARIS – It’s almost official. After eight years of hard-fought negotiating, the European Parliament repealed the 30-page Medical Device Directives governing the Conformité Européen certification, or CE Mark, and adopted the 600 pages of the…

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Members of Parliament call for reciprocal rights as priority in Brexit negotiations

By Nuala Moran, Staff Writer LONDON – Members of parliament scrutinizing the Brexit process have called for a standalone agreement to be made to protect the rights of EU27 nationals living in the U.K. and British citizens in mainland Europe…

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Apax Partners to acquire Syneron for $397M

By Omar Ford, Staff Writer Private equity firm Apax Partners is continuing to keep the medical aesthetics market space hot with its proposed acquisition of Syneron Medical Ltd., also known as Syneron Candela, for $397 million. The acquisition price represents…

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Endologix expects new clinical trial to ‘ELEVATE’ its Ovation EVAR procedures

By Omar Ford, Staff Writer Endologix Inc. is on a path to expanding its Ovation platform through its ELEVATE IDE clinical study. The Irvine, Calif.-based company said the 75-patient trial will evaluate the safety and effectiveness of its Ovation Alto…

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Boston Scientific to buy TAVR upstart Symetis for $435M days ahead of IPO

By Stacy Lawrence, Staff Writer Boston Scientific Corp. will acquire Symetis SA for $435 million in cash in an effort to broaden its transcatheter aortic valve replacement (TAVR) portfolio. The Ecublens, Switzerland-based company had been expected to list publicly at…

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Mount Sinai study finds knee replacement benefits accrue mostly in severe population

By Stacy Lawrence, Staff Writer New research published in the BMJ finds that total knee replacement may be most useful in osteoarthritis patients with the most severe symptoms, with little quality of life or economic benefit from the use of…

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Organogenesis moves into amniotic tissue market with acquisition of Nutech Medical

By Omar Ford, Staff Writer Organogenesis Inc. is set to acquire Nutech Medical Inc. a private company and supplier of tissue products used in spinal and orthopedic surgeries. Financial details surrounding the deal were not disclosed. Canton, Mass.-based Organogenesis has…

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Microcap iCAD gets FDA okay for deep learning analysis of 3-D mammography

By Stacy Lawrence, Staff Writer iCAD Inc. has secured a PMA approval from the FDA for the computer-aided detection product for digital breast 3-D tomosynthesis that is based on deep learning. The product is already available via Chicago-based partner GE…

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