U.S.-based device makers have been grappling with FDA cybersecurity requirements for some time, but now the European Union (EU) is working on cybersecurity regulations as well. Throw in privacy requirements by the state of California and the EU’s General Data Protection Regulation (GDPR), and device makers are facing an increasingly complicated world of enforcement and litigation.

NATIONAL HARBOR, Md. – Cardiovalve Ltd., of Or Yehuda, Israel, scored a double hit with the U.S. FDA, winning a breakthrough device designation for its transcatheter tricuspid valve replacement system, as well as approval to conduct an early feasibility study in tricuspid regurgitation (TR).

Asuragen Inc., an Austin, Texas-based molecular diagnostics company, has received good news from the U.S. FDA. The agency gave the green light for the company’s Amplidex Fragile X Dx and Carrier Screen Kit, which aims to detect a genetic condition known as Fragile X syndrome. The diagnostic kit determines the number of cytosine-guanine-guanine (CGG) repeats in the FMR1 gene to aid in the diagnosis of Fragile X syndrome and associated disorders, including Fragile X-associated tremor/ataxia syndrome and Fragile X-associated primary ovarian insufficiency.

The U.S. Centers for Medicare and Medicaid Services (CMS) announced it may tack on another three years to the Comprehensive Care for Joint Replacement (CJR) program, proposing among other things to drop the 50% cap on gainsharing payments. Analysts with Cowen Washington Research Group, of New York, said post-acute care providers are at greater risk than device makers with the extension, however, due to the fact that hospitals have several choices in terms of discharge destination, including the patient’s home.

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PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has issued a draft guidance to help sponsors better understand the evidence requirements for market authorizations for medical devices, including in vitro diagnostics (IVDs) and software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

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.