PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) will begin accepting applications from domestic companies to become conformity assessment bodies (AU CAB) beginning July 1. The aim is to allow approved Australian corporations to issue conformity assessment certification for medical devices under Australian law to align with the country’s essential principles.

Early feasibility studies for cardiology devices were a massive problem for the FDA and industry in times gone by, a problem that was believed to drive device flight from the U.S. That problem has been largely solved, according to the FDA’s Andrew Farb, but Farb noted that neurological devices are the next target for improved early feasibility study (EFS) development in the U.S., which suggests that the path to pivotal studies for devices in this space will soon be much less cumbersome.

Two weeks ago, it was a grilling by the House Oversight Committee over the pricing of blockbuster drugs Humira and Imbruvica and a request for the FTC to launch an investigation into Abbvie Inc.’s patent settlements that delayed Humira biosimilar competition in the U.S. until 2023. This week, Abbvie became the face of a new investigation by the Senate Finance Committee over how multinational companies are shifting profits overseas as a way to avoid U.S. taxes.

Alivecor Inc. has elevated its patent dispute with Apple Inc. to the U.S. International Trade Commission (ITC) in a move that could damage the latter’s foray into digital health. Alivecor is alleging that Apple, of Cupertino, Calif., has infringed on Alivecor patents for electrocardiogram monitoring technology, a development that may foreshadow a continuing legal struggle between the two companies for a large and rapidly growing market.

Edwards Lifesciences Corp. has won the FDA’s nod for its Acumen hypotension prediction index (HPI) software with the Acumen IQ finger cuff. Prior to receiving this 510(k) clearance, the low blood pressure prediction software was only available for patients using an invasive arterial line. The Acumen HPI software uses data gleaned from the Acumen IQ cuff, along with machine learning, to alert clinicians if a patient is at risk of hypotension, drops in pumping pressure that reduce the flow of oxygenated blood and nutrients to the body’s vital organs.

Borrowing a chapter from venture capitalists, the U.S.’ Biomedical Advanced Research and Development Authority (BARDA) is partnering with the nonprofit Global Health Investment Corp. (GHIC) to accelerate the development and commercialization of medical technologies and products needed to respond to or prevent future pandemics and other public health emergencies.

Acting FDA commissioner Janet Woodcock appeared at the annual forum held by the Medical Device Innovation Consortium (MDIC) and noted that real-world evidence (RWE) has tremendous potential in regulatory decision making. However, she cautioned that while “the future is very bright” for RWE, “it’s going to take longer than some of the enthusiasts might have thought” to maximize this source of data in product reviews.