Roche (SIX: RO, ROP; OTCQX: RHHBY) today announced that the FDA has cleared its Elecsys Phospho-Tau (217P) Plasma (pTau217) blood test that identifies amyloid pathology associated with Alzheimer’s disease. The test is cleared for people 55 and older with signs of cognitive decline to be used in conjunction with clinical information in assessing Alzheimer’s risk. When the FDA approved the first […]
Neurological
MicroPort wins FDA breakthrough nod for drug-eluting stent
MicroPort announced that it received FDA breakthrough device designation for its Apollo Dream sirolimus target-eluting stent system. Apollo Dream, an investigational, balloon-expandable, rapid-exchange drug-eluting stent system, is designed to provide vascular scaffolding and restore. cerebral blood flow. It aims to treat intracranial atherosclerotic disease (ICAD), a leading cause of ischemic stroke. The stent incorporates a […]
CraniUS closes $20M financing to support blood-brain barrier tech for drug delivery
CraniUS Therapeutics announced today that it raised $20 million in a Series B financing round to accelerate its development of NeuroPass. NeuroPass is a fully implantable, skull-embedded platform. The Baltimore-based company designed it to bypass the blood-brain barrier (BBB). It could enable targeted drug delivery and monitoring in the brain. CraniUS has NeuroPass under development […]
ClearPoint Neuro is developing a robotic neuro-navigation system for drug delivery
ClearPoint Neuro (Nasdaq:CLPT) announced today that it is developing a proprietary robotic neuro-navigation system. The Solana Beach, California-based company says its new product category can enable its navigation software to operate the Kuka LBR robotic arm, supporting all minimally invasive cranial surgical procedures. Those include cell and gene therapy infusions, laser catheter placement, biopsy workflows […]
Vivani sets date for neuromod spin-off as focus turns to drug delivery implant
Vivani Medical (Nasdaq:VANI) announced today that it set a record date for the approved spin-off of its Cortigent subsidiary. In May, the Alameda, California-based company announced plans to spin off Cortigent, its division developing brain implants. The company wants to create two focused companies dedicated to driving current and future value in their respective therapeutic […]
Convatec wins FDA approval for Parkinson’s treatment infusion tech
Convatec announced today that it received FDA approval for the delivery of a Parkinson’s disease therapy through its Neria Guard infusion set. The FDA approved apomorphine hydrochloride for subcutaneous infusion for the treatment of Parkinson’s. London-based Convatec’s Neria Guard set delivers the therapy under the skin (subcutaneous) as a continuous infusion via a small portable […]
Vivani files with SEC to spin off neurostim business, focus on drug delivery implants
Vivani Medical (Nasdaq:VANI) announced today that it filed a Form 10 registration statement with the SEC to spin off its neurostimulation unit. The company said earlier this year that it plans to spin off Cortigent, a division that develops brain implants. The company wants to create two focused companies dedicated to driving current and future […]
Vivani to spin out neurostim business, focus on GLP-1 implant
Vivani Medical (Nasdaq:VANI) announced today that it plans to spin off Cortigent, a division that develops brain implants. The company wants to create two focused companies dedicated to driving current and future value in their respective therapeutic areas. Vivani aims to continue advancing its miniature GLP-1 therapeutic implants. The spin-off would enable Cortigent to continue […]
CereVasc data shows that eShunt could help deliver gene therapies to the central nervous system
CereVasc shared data from a study demonstrating that its eShunt system may help deliver gene therapies to the central nervous system (CNS). eShunt, a minimally invasive system, includes an endovascularly implantable cerebral spinal fluid shunt and delivery components. CereVasc designed the system to enable transvenous-transdural access to the CNS to treat communicating hydrocephalus (CH) without […]
Elutia announces first implant of drug-eluting bioenvelope for pacemakers and neurostimulators
Elutia (Nasdaq:ELUT) announced the first-ever patient implant of its EluPro drug-eluting biologic envelope cleared by the FDA. Dr. John Catanzaro of the East Carolina University Health Medical Center in Greenville, North Carolina, performed the first procedure. Elutia says this marks the first implant of the world’s first antibiotic-eluting biologic envelope. Elutia designed EluPro to prevent […]
