In a grand slam for Dexcom Inc., the U.S. FDA cleared its Stelo glucose biosensor system for over-the-counter marketing, making it the first integrated continuous glucose monitor available without a prescription. Designed for use by the 25 million adults with diabetes who do not use insulin and do not have problematic hypoglycemia, the FDA indication expanded the clearance for Stelo to include individuals without diabetes “who want to better understand how diet and exercise may impact blood sugar levels,” dramatically expanding the market opportunity. Read More
Superhuman soldiers. Designer babies. Genetically tailored weapons. Mind-control. A foreign database containing the DNA of every person on the planet. The list reads like the plot of a science fiction horror story, but there’s no fiction involved. These are real threats from China raised by members of the U.S. House Select Committee on the CCP (Chinese Communist Party) at a March 7 hearing on the growing stakes of the bioeconomy and American national security. Read More
The U.S. FDA granted Edap Tms SA breakthrough device designation for its Focal One system to treat deep infiltrating rectal endometriosis. The company believes that the Focal One high intensity focused ultrasound technology can offer relief to the thousands of women suffering from the debilitating condition. Read More
The U.S. FDA’s warning letter to Fresenius Kabi AG of Homburg, Germany highlighted several problems with the compliance practices at the company’s plant in North Andover, Mass., but there is more than just a compliance issue at play. Fresenius had acquired the Ivenix infusion pump and the inspected research and development site in its 2022 acquisition of Ivenix Inc., another example of the regulatory and compliance hazards of acquisitions in the med-tech space. Read More
As geopolitical tensions mount, bipartisan legislation introduced in both the U.S. Senate and the House is calling to prohibit government contracts with certain Chinese biotechs such as BGI (formerly known as Beijing Genomic Institute) and Wuxi Apptec, because they are increasingly seen as national security threats. Read More
In what represents the first patenting in the name of Houston-based Neurastasis Inc., company co-founders Kirt Gill and Joe Upchurch describe a head-worn apparatus for neural stimulation that can be used to treat or augment recovery from medical conditions, particularly ischemic stroke. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbott, AI Medical Technology, Neuroelectrics, Sensible Medical. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bruker, Calyx, Chemspeed, Healthy.io, Invicro, Natera, Neuronetics, QT Imaging, Realm Idx Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Co-Diagnostics, Cosara, Quidelortho, Surgentec. Read More
