Teva (NYSE:TEVA) last week won FDA approval for its humanized monoclonal antibody, Ajovy, designed to prevent migraines. The treatment, which blocks the receptor for a protein that is linked to migraine pain, is available in quarterly and monthly-injection options. Amgen‘s (NSDQ:AMGN) competitive once-monthly product won FDA approval earlier this year. Get the full story at our sister site, […]
FDA pushes back decision date for Acorda’s Parkinson’s drug
Acorda Therapeutics (NSDQ:ACOR) said today that the FDA pushed back its goal date for the agency’s review of Acorda’s inhaled levodopa Parkinson’s therapy. The FDA’s date to make a decision about Acorda’s Inbrija product was moved from Oct. 5, 2018 to Jan. 5, 2019. The Ardsley, N.Y.-based company said the extension is related to submissions it […]
Minnetronix rebrands, eyes neuro market
Minnetronix said today that it’s adding “Medical” to its name, unveiling a new corporate look to emphasize its focus on the neurocritical care market. Founded in 1996, the St. Paul, Minn.-based company said it’s developing a line of devices for the neurological ICU, beginning with the Neurapheresis device for treating post-aneurysmal subarachnoid hemorrhage. A first-in-human study is already […]
Longeviti’s ClearFit gives neurosurgeons a view inside the head
Longeviti Neuro Solutions has launched its novel ClearFit implant to correct and/or restore bony voids or defects of the cranium. This clear, patient-specific implant enables neurosurgeons to see neuroanatomy and critical functional components beneath the ClearFit once it is implanted. “The real advantage to this system is the ability to see what’s underneath the […]
BrainScope lands $4.5M to add vision assessment to its technology
The U.S. Department of Defense has awarded BrainScope a $4.5 million research contract to create and integrate ocular capabilities into its handheld, multi-parameter mild traumatic brain injury (mTBI) and concussion products. The Bethesda, Md.-based company’s initial product, BrainScope One, is the first FDA-cleared medical device that can assess the full spectrum of brain injury – from concussions (functional […]
Otsuka inks collab deal to bring Abilify Mycite drug-device combo to US
Otsuka Pharmaceutical (TYO:4578) said today it inked a collaborative deal with health management group Magellan Health to distribute its drug-device combo Abilify Mycite in the US. The Tokyo-based pharmaceutical company touted the Abilify Mycite system as the first FDA-approved drug-device combo designed to track drug ingestion, and said that the tracking data will be integrated into […]
FDA grants expanded clearance for MagVenture’s depression-treating TMS system
Non-invasive magnetic stimulation developer MagVenture said today it won expanded FDA clearance for its Transcranial Magnetic Stimulation system, now cleared for treatment protocols with shorter treatment sessions. The Atlanta-based company said a new treatment form using its TMS hardware, dubbed theta burst stimulation, can now be provided in three-minute sessions, down from previous treatment protocols which required […]
Brainsway wins FDA nod for OCD-treating TMS system
The FDA today said it granted de novo approval for Brainsway‘s deep transcranial magnetic stimulation system, now indicated for treating obsessive compulsive disorder. The TMS system uses magnetic fields to simulate nerves in the brain, and has been shown to reduce the severity of OCD in patients. A 100-patient randomized, multi-center study of the device […]
J&J’s Cerenovus wins CE Mark for Bravo flow diverter
Johnson & Johnson‘s (NYSE:JNJ) Cerenovus said this week it won CE Mark approval in the European Union for its Bravo flow diverter designed to treat intracranial aneurysms. The newly cleared device is designed to divert blood flow from aneurysms to promote healing and reduce the risk of rupture, the company said. The Bravo is Cerenovus’ first flow […]
ElectroCore inks nVNS neuroinflammatory response research deal with MGH
ElectroCore said yesterday it inked a collaborative research deal with Massachusetts General Hospital exploring the use of ElectroCore’s non-invasive vagus nerve stimulation tech in targeted treatments for neuroinflammation. The Basking Ridge, N.J.-based company said that investigators will examine the effects the nVNS system has on neuroinflammatory mechanisms associated with conditions in the central nervous system including […]
ARTMS’ system may ease cost, shortage of valuable radioisotopes
ARTMS Products (Vancouver, B.C) has won the CE mark for its first-in-class, advanced technology Quantm irradiation system, designed to produce high-value medical imaging isotopes such as technetium-99m (Tc-99m) on medical cyclotrons. Tc-99m is given to nearly 50,000 Americans every day to diagnose cancer and heart disease. It is used in more than 80% of all nuclear […]
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