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Friday, January 19, 2018

BREAKING NEWS

Grünenthal Group Receives CE-Certification for Innovative Surgical Sealant

1/19/18: Grünenthal announced today that Adhesys Medical GmbH, a wholly-owned subsidiary of the Grünenthal Group, has received CE-Certification for MAR-CUTIS (Flix®). Flix® is a topical skin adhesive for surgical use and the first product from Grünenthal's innovative pipeline of surgical sealants. Further products, especially for use inside the body, are under development (MAR-VIVO product family).

Laminate Medical Technologies Announces Enrollment of First Patients in Pivotal Trial of the VasQ Device

1/19/18: Laminate Medical Technologies (Laminate), a privately-held start-up developing VasQ, an implanted blood vessel external support device for patients requiring arteriovenous fistula as vascular access for hemodialysis, today announced the launch of its FDA pivotal study in the US.

EDETEK and ClinSmart Announce Partnership

1/18/18: EDETEK, the premier provider of digital clinical trial platforms, today announced that the company has entered into a partnership with ClinSmart, a trusted, full-service contract research organization (CRO), to offer comprehensive clinical trial capabilities.

First Outpatient Center in the United States to Have Globus ExcelsiusGPS™, Revolutionary Robotic Navigation Platform

1/18/18: On January 8, 2018, Robotics Outpatient Center, Los Angeles: ROC-LA, became the First Outpatient Surgery Center leading the United States in the field of robotic guidance and navigation with the purchase of Globus ExcelsiusGPS™.

Robert Ruff Joins NSF International as Executive Director, Medical Device Certification and Training

1/18/18: Ruff is a former U.S. regulator to medical device certification and training programs

CareCloud Appoints Greg Novak VP of Channel Sales

1/18/17: CareCloud, the platform for high-growth medical practices, today announced that Greg Novak has joined in a newly created role as vice president of channel sales.

SCRA Announces South Carolina Launch Investment in Extremiti3D

HOMEExtremiti3D is addressing the needs of the 1.5 million lower limb amputees in the United States. By...

The Optical Society Reports: New Instrument Lets Doctors View the Entire Eye with Unprecedented Level of Detail

1/18/18: Researchers have developed the first instrument that can provide a detailed image of the entire eye. By incorporating a lens that changes optical parameters in response to an electric current, the innovative technology can produce higher quality images than currently available and could make eye examinations faster and more comfortable for patients by avoiding the need to undergo imaging with multiple instruments to look at different areas of the eye.

Becton Dickson Completes Enrollment in the Lutonix™ 014 Drug Coated Balloon Below-The-Knee Trial

1/18/18: Today Becton, Dickinson and Company announced the completion of enrollment in the Lutonix below-the-knee trial and plans to submit a pre-market approval application in late 2018.

International Biophysics Obtains FDA 510k Clearance for FloPump® 32 Centrifugal Heart Pump

1/17/18: International Biophysics Corporation, a global medical device manufacturer based in Austin, Texas, announced they have received FDA 510k clearance for their FloPump 32 centrifugal disposable heart pump.

NOTEWORTHY

1/19/18: Catalyst OrthoScience, Inc. has been granted four new patents by the United States Patent and Trademark Office for technologies incorporated in the CSR™ Total Shoulder Replacement System.
1/19/18: To deliver a boost to the Medical Device Industry in China, the Chinese government has proactively launched several policies directed at medical device innovation which focus on speeding up innovative Medical Device Approval and High-end medical device localization, such as "Opinions on Deepening the Innovation of Inspect and Approval System for Drugs, and Encouraging Medical Devices Innovation", and "Three-year action plan to enhance core competitiveness of manufacturing industry (2018-2020)"
1/18/18: Neurosurgical medical device maker of the world's first and only trans-sulcal system for standardized subcortical surgery, NICO Corporation, today announced Tim Davis as the new Vice President of Sales.
1/18/18: Bluegrass Vascular Technologies, a private medical technology company focused on innovating lifesaving devices and methods for vascular access, today announced the enrollment of its first patients in the SAVE-US (Surfacer® System to Facilitate Access in VEnous Occlusions – United States) pivotal trial.
1/18/18: Cardiovascular Systems, Inc. today announced two new partnerships broadening the company’s product portfolio. CSI is now the exclusive U.S. distributor of OrbusNeich balloon products. Additionally, the company has signed an original equipment manufacturer agreement with Integer Holdings Corporation for CSI-branded ZILIENT™ guidewires.
1/17/18: WiserCare, a leading digital patient decision support platform, announced today the appointment of Daniel J. Castillo, MD, MBA, as the company’s CEO.
1/17/18: The Corporate Whistleblower Center says, "Hospitals bribing or providing incentives to physicians for admissions should not come as a surprise to anyone. However, if a hospital is bribing or providing incentives for medical doctors to admit people to a specific hospital - it is probably a violation of the Stark Act.
1/17/18: Cervical cancer contributes to approximately 6-29% of all cancers in Indian women India accounts for one-quarter of cervical cancer globally 17% of all cancer deaths amongst women in India aged 30-69 are due to cervical cancer EVA System visualisation technology offers potential for early detection of cervical cancers
1/16/18: Millar, Inc., a leader in medical device manufacturing, supports the increased understanding of airway physiology through the adoption of the Mikro-Cath pressure catheter in obstructive sleep apnea studies.

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