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. Read More
Merck & Co. Inc. telegraphed the future focus of Organon & Co., which will spin off from the pharmaceutical giant as a public company in the first half of 2021, with an announcement of an agreement to acquire Alydia Health Inc. Alydia makes the Jada system, which treats postpartum hemorrhage. Read More
PERTH, Australia – In a boost for Australia’s medical technology innovators, A$3.2 million (US$2.4 million) in partnership projects are being deployed to help get innovative new medical devices to the next steps of starting human trials and early-stage manufacturing. Read More
TORONTO – “There’s no magic pill that helps patients with concussion except physical activity,” Ashleigh Kennedy, CEO of Neurovine Inc. told BioWorld. But how does a patient in rehab know when to put on the brakes if they’re working too hard physically or mentally? Read More
As COVID-19 vaccinations continue to roll out, momentum builds with strong phase III data for what could become the fourth and fifth walls of defense in the U.S. Read More
New hires and promotions in the med-tech industry, including: Clover Health, Eyenovia, Inscopix, Lantheus, Sciex, Second Sight, Spire Health. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aditx Therapeutics, Collection Sites, Concert Genetics, Corvida Medical, Dalrada, Dedalus, Dx Medical Solutions, Dxc Technology, Egenesis, Euroimmun, Fresenius Kabi, Genematters, Guardant Health, Health Clinics, Invitae, Lifestance Health, Medivolve, Meridian Bioscience, Myomo, Ontrak, Pear Therapeutics, Perkinelmer, Premier, Prescryptive Health, Sqi Diagnostics, Stagezero Life Sciences. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Becton Dickinson, Bluestar Genomics, Inspire. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: MDIC accepting applications for the ASC pilot study. Read More
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. Read More
