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.

Biointellisense Inc. received good news from the U.S. FDA, which gave its nod to the company’s Biosticker on-body sensor for scalable remote care. The Biosticker allows for continuous monitoring of vital signs and actionable insights, delivered to clinicians from patients in the home setting. The goal is to help in the early detection of potentially avoidable complications.

Tempe, Ariz.-based Gt Medical Technologies Inc. has won the U.S. FDA’s nod for an expanded indication for Gammatile therapy. With this decision, patients with newly diagnosed malignant brain tumors now are eligible to receive the FDA-cleared surgically targeted radiation therapy. Gammatile therapy offers an option vs. waiting several weeks for surgical wound healing before beginning treatment. Previously, the therapy was available for individuals with recurrent brain tumors.

Irvine, Calif.-based Masimo Corp. has agreed to buy the connected care assets of Nanthealth Inc., of Culver City, Calif., for a $47.25 million up-front cash payment. In addition, Masimo provided estimates for its full-year 2020 financial guidance, saying product revenue will increase to $1.035 billion, which reflects reported growth of 10.6% to 10.9%. The transaction is expected to close in the first quarter of the year, subject to customary closing conditions. In addition, Masimo expects to fund the acquisition with existing cash on hand.

Abbott Park, Ill.-based Abbott Laboratories has gained the U.S. FDA’s nod for a clinical trial that will compare the effectiveness of Mitraclip to open-heart mitral valve surgical repair in people with primary mitral regurgitation (MR) who are eligible for open-heart surgery. The prospective, randomized REPAIR MR clinical trial is expected to enroll 500 patients.

Duluth, Ga.-based Sebacia Inc., which is focused on dermatology and aesthetics, has introduced its new CEO and reported the acquisition of all assets related to Sienna Biopharmaceuticals Inc.'s silver photoparticle technology, which is being reviewed by the FDA for light hair removal.

What does the landscape look like in terms of funding for digital health? Geoffrey Starr, a partner at Cooley LLP, dove into this question during the Digital Health Summit, part of CES 2020. He acknowledged that 2019 saw a slight dip in funding compared with the record-breaking previous year. With that said, it was the second largest year ever for digital health care financings, with more than one-third of all health care venture financings involving digital health technologies.

LAS VEGAS – The U.S. FDA has said it is looking to help those interested in developing digital health tools, and that commitment took center stage this week during the Digital Health Summit, part of CES 2020. Amy Abernethy, principal deputy commissioner at the FDA, gave an overview of the agency’s thinking on the topic, providing the perspective of someone who came from outside the regulatory world.