Medtronic plc received U.S. FDA approval to undertake an early feasibility study of its dual-energy Affera cardiac ablation system in sustained ventricular tachycardia. Affera combines both radiofrequency and pulsed field ablation technologies in the Sphere-9 catheter along with high-density mapping.
Novocure GmbH secured U.S. FDA approval for Optune Lua, a wearable device that delivers alternating electric fields or tumor treating fields that kill cancer cells. Indicated for use with PD-1/PD-L1 inhibitors or docetaxel in the second or subsequent line for the treatment of metastatic non-small-cell lung cancer following the failure of platinum-based regimens, the approval was driven by the significant improvement in overall survival rates seen in the LUNAR pivotal study for Optune Lua.
Hologic Inc. signed an agreement to acquire Gynesonics Inc. for $350 million. The acquisition will significantly boost Hologic’s revenues from surgical gynecology and provide an option not met by the company’s current portfolio of products.
Ceribell Inc. launched its initial public offering of more than 10.6 million shares of common stock at $17 and steadily saw the trading value rise, before closing just over $25 on Oct. 11 per share. Ceribell, which developed a portable electroencephalogram for use in intensive care and emergency department settings, expected to gross $180.3 million from the IPO excluding any exercise of the underwriters’ option to purchase additional shares. The IPO will close on Oct. 15.
Glooko Inc. secured a $100 million series F financing to support expansion of its diabetes ecosystem platform, which integrates information from more than 200 devices on a centralized, digital data platform that simplifies care for patients and clinicians. At the same time, the company reported the appointment of Mike Alvarez as CEO.
Shiratronics Inc. raised $66 million in an oversubscribed series B financing round to support completion of its recently launched clinical trial to evaluate the safety and efficacy of its neuromodulation device in patients with treatment-resistant chronic migraine.
A digital cognitive assessment developed by Braincheck Inc., Braincheck Assess, proved comparable to the gold-standard Montreal Cognitive Assessment in identifying patients with cognitive impairment in a study published in Frontiers in Psychology.
Implementation of Flosonics Medical Inc.’s Flopatch reduced sepsis-associated mortality more than 80% in a California public hospital, a case study showed. A wearable Doppler ultrasound device, Flopatch continuously assesses blood flow to guide fluid delivery and resuscitation in critically ill patients.
Exact Sciences Corp.’s Cologuard Plus received U.S. FDA pre-market approval as a non-invasive colorectal cancer home screening test. The next-generation, stool-based assay, developed in conjunction with the Mayo Clinic, reduces false positives by 30% compared to the original Cologuard test without diminishing its sensitivity for cancer or advanced adenomas.
