The notion of using vacuum pressure on the anterior portion of the human eye as a treatment for open-angle glaucoma might be a clinical novelty, but Balance Ophthalmics Inc. is poised to change that. The company recently won a favorable outcome at a U.S. FDA advisory panel for its Fsyx negative pressure pump for ocular use, although the company is likely to have to drum up a large body of data in post-approval studies, assuming the FDA gives the Fsyx the nod. Read More
The U.S. biopharma and med-tech industries are adding their voice to that of Gilead Sciences Inc. in urging the California Supreme Court to review the Gilead Tenofovir Cases, which seek to hold the drug company liable for how and when it developed its pipeline of HIV drugs. Read More
It’s game time for Abbott Laboratories’ 15-minute concussion test now that FDA clearance is in hand. The I-Stat traumatic brain injury cartridge uses whole blood, allowing bedside assessment of patients without lab processing. Read More
The U.S. FDA issued a draft guidance for premarket applications for class II bone grafting devices, a policy that would supplement a guidance issued nearly two decades ago. Read More
In what represents its first patenting, Anjo.ai Inc seeks protection of systems for remote monitoring, early detection and notification for life-threatening allergic anaphylactic reactions using wearable sensors and artificial intelligence. The system can recognize an allergic reaction even before the visible symptoms appear.
Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3M, Attune Medical, Haemonetics, Highridge Medical, Hologic, Limbus Ai, Labcorp, Key Proteo, Maverix,Reflexion, Solventum, Xcell, Zimvie. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott Labs, Baird Medical, Baxter, Medline, Siemens Healthineers. Read More
