Graymatters Health Ltd. seeks patent protection for its non-invasive, self-neuromodulation approach for treating post-traumatic stress disorder. In what represents the company’s second PCT filing, GMH’s co-founders, Oded Kraft, Rani Cohen and Shai Attia, describe a method for achieving a reduction of at least six points in a Clinician-Administered PTSD Scale for DSM-5, following neurofeedback treatment delivered for eight to 12 consecutive weeks.
The U.S. FDA posted notice of a medical device correction of Abiomed Inc.'s Impella series of left-side blood pumps because of the risk of perforation of the left ventricle during device placement. The FDA noted that it has received 129 reports of serious injury and 49 reports of fatalities associated with these devices, but did not indicate whether device malfunction was the source of these adverse events. Abiomed advises customers that the device should be implanted “with special care” in patients during active cardiopulmonary resuscitation, and to review some updated warnings in the product’s instruction for use statement.
Stimlabs LLC received U.S. FDA approval for Corplex P, a wound care product that uses placental tissue to facilitate wound healing. “Corplex P is the first particulate device derived from human umbilical cord extracellular matrix indicated for the management of acute and chronic wounds,” Stimlabs CEO John Daniel told BioWorld.
Johnson Matthey plc agreed to sell its medical device components business to Montagu Private Equity for £550 million ($700 million) on a cash-free, debt-free basis. For Montagu, the deal is part of its expanding health care portfolio. Earlier in 2024 the private equity firm, which is the primary shareholder in RTI Surgical Inc., acquired Cook Biotech Inc. from Cook Medical Inc. and merged the two companies.
A metabolite that suppresses appetite and food intake after exercise could be the reason for the weight loss observed in patients treated with metformin to control blood glucose. A study conducted by a group of scientists at Stanford University showed how this antidiabetic drug induced the biosynthesis of N-lactoyl-phenylalanine (Lac-Phe), which has an effect reducing the body mass index.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Butterfly Network, Intuitive Surgical, Sequel.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: BD, J&J, Johnson Matthey, Hatch Medical, Pavmed, Serf, Setpoint, Siemens, Stryker.