Edwards Lifesciences Corp., of Irvine, Calif., reported positive quarterly results Jan. 30, and it was particularly bolstered by strength with transcatheter aortic valve replacement (TAVR). CEO Mike Mussallem called out the fourth quarter underlying sales growth of 19%, giving much credit to TAVR.

Stryker Corp., of Kalamazoo, Mich., saw strength in the fourth quarter, with Mako experiencing good uptake in total knee arthroplasty. Katherine Owen, Stryker’s vice president of strategy & investor relations, said Mako demand was driven by the benefits of its robotic technology, multiple applications and the ability to do cementless knee.

HONG KONG – South Korea’s Genomictree Co. Ltd. has said its U.S. branch, Promis Diagnostics Inc., based in Pasadena, Calif., gained $30.8 million in funds this month. The Daejeon-based company has secured $40.8 million for its U.S. subsidiary since founding it in August 2019.

Despite pressure from several lawmakers to declare the new coronavirus a U.S. public health emergency, Health and Human Services (HHS) Secretary Alex Azar said such a declaration isn’t needed, at least not yet.

Salt Lake City-based Co-Diagnostics Inc. has finished the principle design work for a polymerase chain reaction (PCR) screening test for the novel coronavirus that has sickened nearly 3,000 with an acute respiratory illness and killed more than 80 people in Wuhan, China.

The U.S. Centers for Medicare and Medicaid Services (CMS) has significantly relaxed the national restrictions on coverage of next-generation sequencing for cancer, affirming that early-stage breast and ovarian cancer patients will be covered. However, Medicare administrative contractors can cover tests that have not been reviewed by the FDA, a move that should also significantly boost utilization for makers of next-generation sequencing systems in clinical labs.

Combination products with digital interfaces. Antibody-drug conjugates. Complex drugs. Synthetic biologics. They’re all examples of how technology is expanding the ambit of what’s considered a drug beyond the current U.S. binary regulatory system of small molecules and biologics.

The patent subject matter eligibility problem has rattled the world of diagnostics for several years, but the U.S. Senate has been silent about legislation in recent months. Patent attorney Michael Borella, of McDonnell Boehnen Hulbert & Berghoff LLP (MBHB), said he does not expect Congress to provide any legislative fix to the problem any time soon.

Combination products with digital interfaces. Antibody-drug conjugates. Complex drugs. Synthetic biologics. They’re all examples of how technology is expanding the ambit of what’s considered a drug beyond the current U.S. binary regulatory system of small molecules and biologics.