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Envision Healthcare to be Acquired by KKR for $9.9B

July 17, 2018 Nathan J. Lee

Envision Healthcare Corporation (“Envision”) recently announced an agreement to be acquired by KKR & Co. L.P. (“KKR”) for about $5.5 billion in cash. The transaction is valued at $9.9 billion, including the assumption or repayment of debt.  The transaction remains subject to regulatory and shareholder approvals, but is expected to close in the fourth quarter of 2018.

Stryker to Acquire Surgical Smoke Evacuator Company SafeAir

July 17, 2018 Douglas B. Wentzel

Stryker recently announced an agreement to acquire SafeAir AG, a Swiss surgical smoke evacuation company.  The acquisition will likely close by the end of 2018.

Trump’s Chinese Tariffs Could Cost Medical Device Makers $138 Million Per Year, MITA Says

July 17, 2018 Neil G. Anderson

President Donald Trump’s 25 percent tariffs on Chinese imports went into effect on July 6, a move that, according to industry experts, could have wide-ranging effects on American medical device manufacturers.  In early April, RBC Capital Markets estimated the proposed tariffs could cost the entire medical device industry up to $1.5 billion each year.

Senseonics Gets Green Light from FDA on Implantable Glucose Monitoring System

July 11, 2018 Aaron S. Johnson

Senseonics recently received Premarket Approval from the Food and Drug Administration (FDA) for its Eversense® Continuous Glucose Monitoring (CGM) System. According to Senseonics, the Eversense® CGM System is the first and only implantable device to allow for continuous blood-glucose monitoring for as long as three months.

The FDA’s Medical Device Innovation Challenge: A New Approach to Combat the Opioid Epidemic

June 28, 2018 Alexander D. Zeng

On May 30, 2018, the U.S. Food and Drug Administration launched an innovation challenge as a way to combat the fight against opioid addiction. The challenge was issued to “spur the development of medical devices, including digital health technologies and diagnostic tests that could provide novel solutions to detecting, treating and preventing addiction, addressing diversion and treating pain.”

J&J Accepts Platinum Equity’s $2.1B Offer for its LifeScan Subsidiary; Receives Offer for Advanced Sterilization Products Subsidiary

June 28, 2018 April K. White

On June 12, 2018, Johnson & Johnson announced acceptance of an offer from Platinum Equity, a private investment firm, to acquire its diabetic monitoring unit, LifeScan, for approximately $2.1 billion. In response to the acquisition, Platinum Equity Chairman and CEO Tom Gores said

FDA Unveils Update to Software Precertification Program

June 28, 2018 Jordan M. Cox

The U.S. Food and Drug Administration (FDA) recently updated its software Precertification Program. A working program was originally rolled out in April 2018, but the program was updated in response to requested public input. The FDA expects to roll out a finalized version of the program by December 2018 and to have a pilot test available in 2019.

Medical Device Connectivity Market Reported to Top $2.6 Billion by 2023

June 15, 2018 Tom Cowan

The market for medical device connectivity is projected to reach about $2.6 billion by the year 2023, according to a report published in April 2018 by several publishers.  The report states that the connectivity market for 2018 is expected to be about $940 million.  This equates to a compound annual growth rate (CAGR) from 2018 to 2023 of 23.2%

First Prosthetic Iris Approved

June 12, 2018 Robert J. Hilton, Ph.D.

On May 30, 2018, the Food and Drug Administration announced the approval of the CustomFlex Artificial Iris. According to the FDA, this is the first approved artificial iris. The approval was granted to Clinical Research Consultants, Inc., and the device is marketed and developed by HumanOptics AG.

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