PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has issued a draft guidance to help sponsors better understand the evidence requirements for market authorizations for medical devices, including in vitro diagnostics (IVDs) and software as a medical device (SaMD).

Novocure Ltd. of St. Helier, Jersey, released preliminary fourth-quarter and full-year 2019 results, showing strong momentum with its tumor treating fields (TTF) technology, a noninvasive, antimitotic therapy delivered via the Optune device. Q4 revenue is expected to hit $99.2 million, up 42% from $69.7 million in the same period last year, with anticipated full-year revenue of $351.3 million, also up 42%. In the U.S., net revenues grew 49% to $65.9 million in the last financial quarter.  

The FDA has lost a product jurisdiction case in DC district court to Genus Medical Technologies LLC over its barium sulfate contrast agent. The judge in the case ruled that the agency violated the Administrative Procedures Act in ruling that the product is a drug, but the FDA will have another crack at the matter as the application for the product has been remanded to the FDA.