The 2.3% medical device tax is a thing of the past, and now Medicare coverage is one of the issues that is front and center for the Medical Device Manufacturers Association. MDMA President and CEO Mark Leahey told BioWorld also that while member companies are keen on regulatory harmonization, the struggles in standing up the new European regulatory framework is a far more pressing concern.

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has issued a draft guidance to help sponsors better understand the evidence requirements for market authorizations for medical devices, including in vitro diagnostics (IVDs) and software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

HONG KONG – India’s central government has finally placed most med-tech devices into the category of ‘drugs,’ subjecting them to control under the Drugs and Cosmetics Act, 1940.

With deeming day a little more than a month away, the FDA is taking final steps to ease the transition of simple proteins approved as new drug applications (NDAs) to biologic license applications (BLAs). The March 23 change will open drugs such as insulin and various hormones to new competition, likely bringing in the next wave of biosimilars. And this time, interchangeability could be riding the crest.

The response from industry regarding the Environmental Protection Agency’s (EPA) draft rule for ethylene oxide (EtO) varied considerably, but the Advanced Medical Technology Association (Advamed) argued a fundamental methodological point in its comments to the docket. Advamed’s Ruey Dempsey said the EPA approach to determining safe levels of EtO relies on “a single epidemiological study,” an approach Dempsey said has drawn fire from the National Academies of Science.

Acutus Medical Inc. is working to build itself into a major competitor in cardiac electrophysiology. The latest step to do so is an FDA clearance for its second-generation cardiac mapping software known as Supermap. This works in conjunction with its next-gen Acqmap 3D Imaging and Mapping System. The Carlsbad, Calif.-based startup, which was founded in 2011, is now marketing these in both the U.S. and Europe, where Supermap received a CE mark in October 2019.

A lot of development dollars are shed when the FDA withdraws approval or requests that a drug be withdrawn from the market because new potential risks have come to light. And it’s not just the brand company that feels the loss.