Hologic Inc. is tucking in yet another diagnostics manufacturer, this time with the acquisition of Mobidiag Oy for approximately $795 million. The privately held Finnish-French company develops and markets polymerase chain reaction (PCR)-based tests for acute care testing such as gastrointestinal and respiratory infections, antimicrobial resistance management and health care-associated infections.
Keeping you up to date on recent developments in diagnostics, including: Method measures vital signs using smartphone camera; Improving purity of urine and plasma cfDNA.
Xenter Inc. has officially launched, positioning itself as the first startup device/data/drug med-tech company. The company is developing wireless solutions for interventional cardiology, interventional radiology and neurointerventional radiology.
Xenter Inc. has officially launched, positioning itself as the first startup device/data/drug med-tech company. The company is developing wireless solutions for interventional cardiology, interventional radiology and neurointerventional radiology. The company’s goal is to take the medical devices that have been used most ubiquitously throughout medicine, one by one, and replace them with smart technologies that incorporate such things as software, sensors and signals technologies.
Vysioneer Inc. has won the FDA’s nod for its Vbrain artificial intelligence (AI)-powered tumor autocontouring software. The company said Vbrain is the first AI device to receive FDA clearance for tumor autocontouring in radiation therapy. Vbrain is a neural network-based AI solution, trained from clinical data.
Invitae Corp. has inked a definitive agreement to acquire Genosity Inc., a genomics company with a technology platform for next-generation sequencing (NGS) assays, for approximately $200 million in cash and stock. Separately, the medical genetic testing company reported a $1.15 billion investment, led by Softbank Group subsidiary SB Management, to support ongoing growth initiatives. San Francisco-based Invitae expects the Genosity platform to accelerate the development and launch of its oncology products, including three tests that won FDA breakthrough device designation.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Infections associated with reprocessed urological endoscopes under investigation.
Pancreatic cancer is the third leading cause of cancer death in the U.S., in part because many cases aren’t diagnosed until they are advanced. Bluestar Genomics Inc. wants to change that with its epigenomics technology which can detect early pancreatic cancer from a standard blood draw by analyzing cell-free DNA in plasma. Now, the FDA has provided a bump, granting breakthrough device designation to Bluestar’s noninvasive pancreatic cancer detection test in patients with new-onset diabetes. According to the San Diego-based startup, of an estimated 60,000 patients diagnosed with pancreatic cancer in the U.S., nearly a fourth are found to have new-onset diabetes prior to receiving their cancer diagnosis.
Keeping you up to date on recent developments in diagnostics, including: Blood-based test may help detect early Alzheimer’s disease; AI-based tool helps predict course of COVID-19; Myeloid cells differ in primary and recurrent glioblastoma.
The Federal Trade Commission (FTC) is seeking to block Illumina Inc.’s $7.1 billion purchase of Grail Inc., claiming the deal will “diminish innovation in the U.S. market” for multicancer early detection (MCED) tests, which could be used to flag dozens of tumor types when they are still treatable. Illumina has vowed to “pursue all legal options” to complete its acquisition of Grail, arguing that it does not compete with Grail and is committed to providing “unfettered access” to its NGS technology.
