EDEN PRAIRIE, Minn., June 29, 2017  -- CHF Solutions, Inc., (fka Sunshine Heart, Inc.) (NASDAQ:CHFS) announced today that researchers in the Stanford University School of Medicine’s Department of Pediatrics have received FDA Investigational Device Exemption (IDE) approval to conduct a clinical study to evaluate the safety and effectiveness of CHF Solutions’ Aquadex FlexFlow Aquapheresis System for diuretic-resistant fluid overload in children with acute decompensated heart failure. The randomized multi-center, non-blinded clinical study will assess up to 45 children and young adults ages 6 months to 21 years with heart failure and diuretic-resistant fluid overload.  Heart failure is the leading cause of death in children with cardiomyopathy and congenital heart disease.

TORONTO, June 19, 2017  -- NOVADAQ Technologies Inc. (NASDAQ:NVDQ) (TSX:NDQ) (“NOVADAQ” or the “Corporation”), the leading provider of proven comprehensive fluorescence imaging solutions that improve clinical outcomes and reduce healthcare costs in minimally invasive and open surgeries, today announced that it has entered into a definitive arrangement (the “Arrangement Agreement”) with Stryker Corporation (“Stryker”) pursuant to which Stryker has agreed to acquire all of the issued and outstanding shares of NOVADAQ (the “NOVADAQ  Shares”) for US$11.75 per share in cash, implying a total equity value of approximately US$701 million. The transaction price represents a premium of approximately 95.8% over the closing price of the NOVADAQ Shares on the NASDAQ on June 16, 2017, the last trading day before the announcement of the transaction.

2017-06-15 07:30 ET - News Release

 

MINNEAPOLIS, June 15, 2017  -- Skyline Medical Inc. (NASDAQ:SKLN) (“Skyline” or “the Company”), producer of the FDA-approved STREAMWAY® System for automated, direct-to-drain medical fluid disposal, announces that its European Authorized Representative, Emergo Europe B.V., has notified the Dutch Competent Authority that the Company’s STREAMWAY System meets all requirements and can now be affixed with the CE mark and marketed in 32 European countries.    

 

“Receipt of the CE mark is an important milestone for Skyline Medical and we are very excited to be able to expand the reach of our STREAMWAY System to Europe,” said Dr. Carl Schwartz, chief executive officer of Skyline Medical. “We have already held preliminary discussions with a few European distributors, and with the CE mark in hand we can now advance those negotiations while beginning dialogues with others.

2017-06-14 10:00 ET - News Release

 

QUEBEC CITY, QC and MYRTLE BEACH, VA, June 14, 2017 - TSO3 Inc. (TSX: TOS), an innovator in sterilization technology for medical devices in healthcare settings, today announced that the Company now plans to seek 510(k) clearance for its STERIZONE® VP4 Sterilizer from US regulators for the terminal sterilization of the two duodenoscopes used in the majority of endoscopic retrograde cholangio-pancreatography (ERCP) procedures performed globally.

 

Plans are  to launch regulatory filings with US regulators for both the Olympus TJF-Q180V and Pentax ED-3490TK duodenoscopes within weeks of each other beginning in July 2017.  The Company's goal is to receive US clearance by the end of 2017.  Clearances already exist in Europe and Canada for the terminal sterilization of both of the duodenoscopes.