Device Approval
Endocrinology Drug and Device Update
In a review of the 2024 milestones, Healio | Endocrine Today compiled a list of drugs and devices related to the field that were newly approved, cleared or had label or indication changes. Information was gathered from the FDA website and news releases. We put our best effort into making a complete list and regret any omission. Appearance of a drug or device does not constitute any endorsement by Healio | Endocrine Today, its editors, publishers or editorial board. — The Editors
LFR-260 tele-refractor receives FDA clearance
The FDA cleared the LFR-260, a light field powered subjective tele-refractor, Evolution Optiks announced in a press release.
FDA grants 510(k) clearance for self-directed EEG headset
The FDA has granted 510(k) clearance to Cumulus Neuroscience for its dry-sensor electroencephalogram headset, for self-directed use by adolescents and adults at home or at health care facilities.
FDA approves spinal cord stimulation system for chronic pain
The FDA has approved Prospera, a spinal cord stimulation system to treat those with chronic intractable pain in the upper body and limbs.
FDA grants clearance for neurological monitoring device
Medical device company WISE Srl announced the FDA granted clearance for its Cortical Strip, a single-use device intended to be used on the brain surface for intraoperative neurophysiological monitoring.
Software to guide medical therapy in HF earns FDA breakthrough device designation
Biofourmis announced that its software application to help manage medical therapy in patients with HF has received a breakthrough device designation from the FDA.
Noninvasive venous waveform monitoring device receives FDA breakthrough device designation
VoluMetrix, a biotech startup focused on vital monitoring, announced the FDA granted its venous waveform monitoring device a breakthrough device designation.
Blood gas monitoring system for use during CABG nets FDA clearance
LivaNova announced it received FDA 510(k) clearance for its system for monitoring arterial and venous blood gas parameters during pediatric and adult CABG procedures.
Image Quality Analyzer screening software receives 510(k) clearance
FDA panel recommends against approval of angina relief device
The FDA’s Circulatory System Devices Panel recommended the agency not approve an implantable device to treat refractory angina, saying more data are needed.