Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acarix, Exact Sciences, Glaukos, Nexstim, Lumiradx.
Keeping you up to date on recent developments in orthopedics, including: New treatment allows some people with spinal cord injury to regain hand and arm function; Scientists reveal how gut microbes can influence bone strength in mice; New drug form may help treat osteoporosis, calcium-related disorders; Hip fracture incidence expected to increase substantially in some Eurasian countries.
Cognito Therapeutics Inc. has revealed that its lead product has received breakthrough device designation from the U.S. FDA for the treatment of cognitive and functional symptoms associated with Alzheimer’s disease. The offering is a noninvasive neurostimulation device using gamma frequency technology and is the initial candidate in the company’s pipeline of digital therapeutics for neurodegenerative diseases and other chronic indications.
Steris plc has agreed to buy Cantel Medical Corp. for approximately $3.6 billion, in a cash and stock transaction that unites two key players in the infection prevention space. The combined company offers a number of synergies. Cantel’s medical portfolio is expected to bolster and expand Steris’ endoscopy offerings, with a full-suite of high-level disinfection consumables, capital equipment and services plus single-use accessories.
The U.S. FDA has issued an action plan for regulation of artificial intelligence and machine learning (AI, ML), which includes issuance of a draft guidance for change control for adaptive algorithms. There is no guarantee a final guidance will emerge before 2022, however, leaving developers with another year – perhaps longer – of uncertainty as to how to handle change control for their algorithms.
LONDON – The U.K. has launched a nationwide free testing program to diagnose COVID-19 in people who are asymptomatic, in the latest attempt to stem the tide of infection. Through the program, all local authorities will provide rapid testing using lateral flow devices. In addition, companies will be provided with free tests to set up workplace screening. Initially, the focus of both strands will be on getting people who cannot work from home to come forward for regular checks.
Helix Opco LLC, a company specializing in population genomics, has received de novo marketing authorization from the U.S. FDA for its whole exome sequencing platform, which covers roughly 20,000 genes. The San Mateo, Calif.-based company also picked up 510(k) clearance from the FDA for the first test to run on the Helix Laboratory Platform, a genetic health risk application for late-onset Alzheimer’s disease. That test has been cleared for over-the-counter use in conjunction with the Helix Laboratory Platform.
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