The U.S. Preventive Services Task Force (USPSTF) appears on the verge of expanding colorectal cancer screening to individuals ages 45 to 49, based on its latest draft recommendations. If it does, Exact Sciences Corp. is ready. A study in Cancer Prevention Research demonstrated that the Madison, Wis.-based company's Cologuard multitarget stool DNA test had better than 95% specificity in individuals with nonadvanced precancerous lesions or negative findings on colonoscopy. Read More
The U.S. FDA notice regarding device risk classification proposes to eliminate premarket notification requirements for several device types, a welcome development for industry. However, Amanda Johnston, senior attorney at Gardner Law PLLC, of Stillwater, Minn., told BioWorld that there is a question regarding the provenance of the document, as it fails to identify any FDA staff member. In addition, the notice omits several device types that are solid candidates for down-classification. Read More
Abbott Laboratories plans to launch its Neurosphere Mypath digital health app in the coming weeks, the latest addition to its Neurosphere Digital Care connected health management platform. The new app will enable chronic pain patients trying out Abbott neuromodulation therapies to track and report their pain relief. Read More
From nearly every angle, med-tech financings in 2020 are at a four-year high, raising the industry a whopping $59.7 billion, a 47% increase over the prior year. The records were set despite the deadly SARS-CoV-2 virus that shut down global economies throughout 10 months of the most disruptive year in a lifetime. The pandemic highlighted a widespread need for med-tech technologies, such as diagnostics, for which the industry delivered hundreds of options. Likewise, ventilators, personal protective equipment, telemedicine capabilities and wearables were in high demand. Read More
Opticyte Inc., a medical device startup, is planning the first clinical trial of its cellular oxygen monitor, a new device that could help emergency physicians diagnose sepsis faster and prevent organ failure. The prospective, observational trial is set to launch in mid-2021. Read More
Alzheimer’s disease can be divided into multiple subtypes based on gene expression patterns, investigators at the Mount Sinai School of Medicine reported in the Jan. 6, 2021, issue of Science Advances. The work, corresponding author Bin Zhang told BioWorld, is “the first major finding of subtypes in Alzheimer’s disease.” Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Motus GI, Sml Genetree. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CMS wraps up prior authorization rule; ITC finds no violation of Section 337. Read More
Keeping you up to date on recent developments in neurology, including: Intranasal antipsychotic delivery method promises relief from adverse side effects; Increased risk of Parkinson’s disease in patients with schizophrenia; Elusive link between seizures, cell signaling protein identified. Read More
