Dublin-based Medtronic plc received U.S. FDA approval for an expanded indication for its Pipeline Flex embolization device. The new indication allows options for patients with small or medium, wide-necked brain aneurysms in the territory from the petrous to the terminus of the internal carotid artery (ICA).

Palo Alto, Calif.-based Cognoa Inc. received breakthrough device designations from the U.S. FDA for its digital diagnostic and digital therapeutic devices for autism. Cognoa's digital precision health platform weds machine learning and predictive analytics to parental inputs and diagnostic data and responses to therapeutics to create more personalized care. The single platform aims to help clinicians to come to accurate diagnostic and therapeutic decisions faster and modify treatments.

With an eye toward the quick and safe introduction of magnetic resonance radiation therapy (MR/RT), the MR-linac Consortium reported the launch of the MOMENTUM study. The study will focus on building real-world clinical evidence and insights made possible by MR/RT. It also represents the next step in the development of the Elekta Unity MR/RT system.

Warsaw, Ind.-based Zimmer Biomet Holdings Inc. saw fourth-quarter revenues beating expectations as the company continues its two-year planned turnaround. "The company reported [fourth-quarter] revenue of $2.07 billion, exceeding the $2.06 billion consensus forecast," noted Cowen's Josh Jennings. He noted that both dental and spine & craniomaxillofacial also beat expectations.

Kalamazoo, Mich.-based Stryker Corp. impressed analysts this week, with the company reporting a solid end to the year on Q4 numbers that beat expectations."2018 was a stellar year for Stryker," said Kevin Lobo, Stryker's chairman and CEO, during a call on the earnings. "Following tough comparisons from a successful 2017, we delivered impressive organic sales growth and leveraged adjusted earnings gains."

Almost four months after reporting that it had secured an FDA nod for its B-Laser atherectomy system, Eximo Medical Ltd. has seen the launch and first commercial use of the device for treatment of peripheral vascular disease. "We are starting with OBL (Office Based Labs) and then expanding to hospitals," Yoel Zabar, CEO of the Israeli startup, told BioWorld MedTech when asked about rollout plans in the wake of the system's first use.