Keyword: Food and Drug Administration (FDA)
An FDA panel voted against clearance for Neuronix's transcranial magnetic stimulation device, which targets the brain’s memory and learning centers.
The FDA approved a heart implant from Impulse Dynamics for patients who aren’t able to use a pacemaker or standard therapies.
The FDA’s warning letters to breast implant manufacturers come during newly galvanized agency probes into the long-term safety of silicone implants.
After a limited launch of its automated glucose monitoring system, OptiScan has raised $20 million for a broader rollout.
Biotronik received FDA approvals for six high-voltage cardiac rhythm management devices for treating and resynchronizing tachycardia and arrhythmias.
The FDA will evaluate the state of the science around medical device materials, with subsets of patients developing painful responses to implants.
The FDA will now rule on multiple myeloma drug selinexor by early July, three months later than planned.
Gottlieb challenged industry and academia to invest in new approaches and realign incentives to make clinical research more agile and effective.
Novartis' Sandoz chief exits; NCI director to serve as interim FDA head; C4 poaches new CMO; and Karuna hires another ex-Lilly scientist.
NCI Director Ned Sharpless taking on the role of acting head of the FDA raises some intriguing possibilities for interagency cooperation.