At the American College of Cardiology's (ACC) 24th Annual Scientific Session held this week in Atlanta, SHL Telemedicine Ltd. reported the full results of the Imperial College London TELE-ACS trial, the results of which were also published in the Journal of the American College of Cardiology.
Less than two years after acquiring Sound United for $1.025 billion, Masimo Corp. plans to hive off the consumer audio subsidiary along with consumer health products such as its Stork baby monitor and Freedom smart watch and band. The “rushed” announcement made Friday “came after being informed that Politan intended to nominate directors this week,” said activist investor Politan Capital Management. Politan, which owns 8.9% of the company, secured two board seats in a highly contentious proxy battle last year and nominated two more on Monday morning.
Researchers from the University of Minnesota are seeking patent protection and possible collaborators for their development of three-dimensional (3D) printed skin-wearable photodetector devices.
Metastatic colorectal cancer remains the second leading cause of cancer-related mortality globally, but treatment options are generally limited to RAS mutation status for anti-EGFR therapies. Researchers at the Walter and Eliza Hall Institute of Medical Research (WEHI) in Melbourne developed a method to grow organoids from patient-derived tumor samples that achieved 83% accuracy in predicting patient responses to different therapies.
After years of battling to retain its hold on Grail Inc., Illumina Inc. finally announced that it will be unwinding the ill-fated acquisition of the multi-cancer early detection test maker. In addition to stiff opposition from activist investor Carl Icahn that cost Illumina’s previous CEO and board chair their positions, European and U.S. regulators have consistently opposed the deal.
The U.S. FDA’s draft rule for regulation of lab-developed tests (LDTs) was accorded a mere 60 days for comment, but nonetheless drew support from a number of stakeholders, including Foundation Medicine of Cambridge, Mass.
Abbott Laboratories received U.S. FDA approval for its molecular human papillomavirus (HPV) screening test, expanding the company’s cancer screening tools. The new member of the Alinity M family of diagnostic assays can be used for screening, as recommended by current guidelines, as well as diagnosis and provide detailed information on the potentially cancer-causing genotypes of the virus.
An artificial intelligence (AI) algorithm using voice technology developed by Klick Inc. could be a game changer for diagnosis of type 2 diabetes, helping to identify the 50% of individuals who unknowingly have the disease. The technology uses a six- to 10-second voice clip spoken into a smartphone plus basic health data to detect diabetes in close to nine out of 10 individuals, a study published in Mayo Clinic Proceedings: Digital Health found.
The U.S. FDA’s draft rule for regulation of lab-developed tests (LDTs) carries an exceptionally ambitious timeline of completion and enactment by the time the next user fee agreement kicks in, and some see big problems with the timeline laid out by the agency. However, the FDA’s Elizabeth Hillebrenner said that Congress can tweak user fee legislation such that a specific set of user fee sources kicks in off schedule, thus giving the agency a little more leeway in completing any activity related to the proposed rule.