PERTH, Australia – The Therapeutic Goods Administration (TGA) has unveiled final guidance that details how the Australian regulator considers cybersecurity risks over the life of a medical device, including whose responsibility it is to assess and communicate risk, as well as the expectations for manufacturers under the Essential Principles. Industry had voiced concerns in reaction to the draft version of the guidance – released last December – that related to proposed changes to the Essential Principles and the use of standards. The TGA had proposed two separate guidances – one for device and in vitro diagnostic manufacturers and those that develop software for medical devices and another guidance for users.

Two pieces of legislation of interest to the med-tech industry are making the rounds in Washington. One would require that online sales of contact lenses be accompanied only by a prescription, and the other would bolster telehealth services for methamphetamine addiction in rural areas, where the narcotic's epidemic has taken much of its toll. The bills arrive as other developments suggest an improved environment for contact lenses and telemedicine, auguring a better market for both in the months and years ahead.

Exact Sciences Corp., of Madison, Wis., has inked a deal to acquire Redwood City, Calif.-based Genomic Health Inc., creating a combined cancer diagnostics company with an estimated revenue of $1.6 billion by the end of 2020. The acquisition brings together Exact Sciences' at-home stool DNA test for colorectal cancer, Cologuard, and Genomic Health's Oncotype Dx tests for breast and prostate cancer. The three areas comprise about 40% of all solid tumor cases, according to the companies.