Two years after spinning out of the University of Oxford, Amber Therapeutics is now the proud owner of the technology that serves as the basis for its neuromodulation system.

BioCardia’s dive into its paused phase 3 heart failure trial has failed to identify reasons to be optimistic about the primary endpoint. Weeks after the monitoring board recommended pumping the brakes, the biotech has revealed the study is unlikely to meet its main objective, putting another dent in its share price.

In a flurry of Aug. 31 notices from the FDA, the number of Class I recalls plaguing Getinge’s Cardiosave intra-aortic balloon pumps this year has doubled.

Surgical robot maker Noah Medical has delivered first-in-human clinical data from its Galaxy system, designed to navigate through a patient’s airway and probe the lungs for potential cancers and other conditions.

CAR-T cell therapies have been heralded as a game changer for blood cancers, but those therapies approved so far have been focused on a few subtypes of leukemia, lymphoma and myeloma. Now, a new strategy that leverages CRISPR to create CAR-Ts that target a ubiquitous antigen has shown potential to treat all forms of the three hematological diseases.

In recent years, as ventilators have become increasingly crucial amid the COVID-19 pandemic, malfunctioning devices have been a constant burr in the FDA’s side.

ADC Therapeutics is stepping away from a solid tumor pact with Adagene rather than take the collaboration to the next stage.

Elizabeth Amirault had never heard of a Narx Score. But she said she learned last year the tool had been used to track her medication use.

Genexine’s once-weekly growth hormone has matched daily injections in a pivotal trial in China, teeing it and its partners I-Mab and Jumpcan up to file for approval next year and prepare to launch the medicine.

Abbott aims to build optical coherence tomography into a preferred tool for guiding the placement of stents that increase blood flow to the heart muscle. But a pair of major late-breaking studies comparing OCT to other imaging techniques have delivered mixed results.