Mount Sinai Archives - Medical Design Sourcing

Cleveland Clinic, Mount Sinai decide to not use aducanumab for the foreseeable future

The drama surrounding the Alzheimer’s drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) continues with the Cleveland Clinic and Mount Sinai refusing to use it until more data are available.

The company’s stock dropped 6.79% to $328.16.

After FDA decided to conditionally approve the drug for Alzheimer’s disease, three members of an FDA advisory committee have resigned, and politicians and advocacy groups such as Public Citizen have asked for the resignations of senior FDA officials. FDA recently agreed to narrow the indication for the drug to focus on patients with milder forms of the disease. FDA itself has called for an independent review of its dealings with Biogen leading up to its approval of the drug. Some internal staff members at FDA have also expressed reservations about the approval, according to The Wall Street Journal.

The Cleveland Clinic said its doctors can still prescribe aducanumab but that patients will need to receive the treatment a…

Could BrainCheck’s simple test help COVID long-haulers?

(Image courtesy of BrainCheck)

BrainCheck’s eponymous mobile neurocognitive test can detect dementia and concussion. But it has a new application: post-COVID brain fog.

Developed by neurologists at Baylor College of Medicine’s Eagleman Laboratory for Perception and Action, BrainCheck carries an FDA Class II Software as a Medical Device (SaMD) designation and can be used on a tablet or laptop in person or remotely, according to the Houston-based startup.

Get the full story on our sister site, Medical Design & Outsourcing.

Could BrainCheck’s simple test help COVID long-haulers?

(Image courtesy of BrainCheck)

BrainCheck’s eponymous mobile neurocognitive test can detect dementia and concussion. But it has a new application: post-COVID brain fog.

Developed by neurologists at Baylor College of Medicine’s Eagleman Laboratory for Perception and Action, BrainCheck carries an FDA Class II Software as a Medical Device (SaMD) designation and can be used on a tablet or laptop in person or remotely, according to the Houston-based startup.

Get the full story on our sister site, Medical Design & Outsourcing.

Bio-Techne, Kantaro Biosciences to produce COVID-19 serology test

Bio-Techne (NSDQ:TECH) and Kantaro Biosciences announced a partnership to manufacture and distribute COVID-19 serology tests.

Kantaro, a commercial affiliate of the Mount Sinai Health System in New York, will collaborate with Bio-Techne to develop a test kit based on the Mount Sinai-developed coronavirus test and scale the manufacturing and distribution of those kits. The companies formed a joint commercialization and distribution team to support the rapid distribution of the assay.

Initial kit production capacity is expected to allow laboratories to conduct more than 10 million tests monthly, starting in July and scaling to higher capacity in the following months.

Mount Sinai’s test kit, which received FDA emergency use authorization (EUA) in April, is an enzyme-linked immunosorbent assay (ELISA) for measuring the presence or absence of anti-COVID-19 antibodies and the level of antibodies a person has produced. It uses a blood-draw designed for ea…