Innovative medical devices are the norm for reviewers at the U.S. FDA’s Center for Devices and Radiological Health (CDRH), but regulatory innovation is a tougher climb. In response, CDRH director Jeff Shuren said at this year’s Medtech Conference in Boston that the agency is eyeing a voluntary alternative pathway (VAP) for novel digital technologies, although this concept is unlikely to see the regulatory light of day other than as a pilot program at any point in the next year or two, given the need for statutory authorization. Read More

Cresilon Inc. raised $25 million in a series A-4 financing round led by Paulson Investment Co. The funds will be used to commercialize its plant-based hemostatic gel for human applications and bring it to global veterinary markets. Known as Vetigel in animal medicine, the product is used by veterinarians to instantly stop bleeding in dental and surgical procedures and emergency situations in the U.S., U.K., Europe and Canada. Read More

A U.S. FDA advisory panel saw a number of problems in the clinical trial for the Avertd test for opioid use disorder (OUD), including the fact that the study failed to enroll a sufficiently ethnically diverse body of subjects. Perhaps more damning was that the advisory panel was uncertain as to whether the 15 single nucleotide polymorphisms (SNPs) evaluated in the test were helpful in sorting out which patients were truly at high risk of OUD, leading to an 11-2 vote that the probable benefits of the test do not outweigh the risks. Read More

Implanet SA reported having raised $2.7 million to ramp up commercial distribution of its spine implants designed for minimally invasive surgery for spine deformities. The exercise took the form of a capital increase in cash with maintenance of shareholder preferential subscription rights launched a month ago. Read More

GE Healthcare has introduced an all-digital PET/CT System featuring a new category of digital BGO (crystal-based gamma ray detection) employing a smaller crystal size to deliver greater spatial resolution than other digital scanners. Pitched at the European Association of Nuclear Medicine’s annual meeting in Barcelona on Oct. 16, Omni Legend was designed to accelerate scan times and has demonstrated, according to GE Healthcare global chief marketing officer Sonia Sahney, “impressive small lesion detectability.” Read More

New hires and promotions in the med-tech industry, including: Better Therapeutics, Element Science, Indigo Diabetes, Indigo Medical US, Intuity Medical, Pleno, Syantra. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Advanced Oncotherapy, Aurora Spine, Castle. Read More

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aspen Surgical, Bios Health, Bright Research, Delphi Diagnostics, Gore, Livanova, Precision Optics, Quantum Leap Healthcare, Symmetry Surgical. Read More

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Novacyt, Radiaction, Transit Scientific. Read More