FDA clears Accuray's entire body CyberKnife radiosurgery:
This article was originally published in Clinica
Executive Summary
Accuray has received US FDA 510(k) clearance to market its robotic system for providing noninvasive radiosurgical ablation therapy for lesions anywhere in the body where radiation treatment is indicated. The CyberKnife with Dynamic Tracking Software is a stereotactic radiosurgery system that integrates robotics with image-guidance technology to destroy small tumours with large doses of accurately targeted radiation. The CyberKnife was previously cleared by the FDA in 1999 for use in the head and neck above the cervico-thoracic junction, says the Sunnyvale, California firm.
You may also be interested in...
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.