Smart Meter LLC has launched its Iglucose blood glucose monitoring system for managing gestational diabetes. According to the CDC, every year, 2% to 10% of, or 700,000, pregnancies in the U.S. are affected by gestational diabetes, with incidences increasing worldwide. Usually tested around week 24 of pregnancy, gestational diabetes can cause severe complications in women including preeclampsia, hypoglycemia and babies born large for gestational age. Read More
The wave of home-use tests for the COVID-19 pandemic has amplified the question of how device makers might validate such a test, but there is also the question of how to convert a device from prescription-only (Rx-only) use to over-the-counter (OTC) status to consider. The FDA has provided an update on OTC devices, which indicates that a conversion from prescription-only use to OTC use will require usability testing and a new regulatory filing, but the update conflicts with the agency’s own policy on changes to a device undertaken only to convert the label from prescription to OTC use. Read More
PERTH, Australia – Cardiovascular medical device company Venstramedical Ltd. has raised $2 million in seed funding to support development of a small catheter-inserted collapsible heart pump. The Sydney-based company is aiming to develop devices that provide cardiac support for failing hearts without the use of surgery, Venstramedical co-founder and CEO Martin Cook told BioWorld. Read More
Eclipse Regenesis Inc. received a National Institutes of Health fast track grant of $1.7 million to advance development of the Eclipse Xl1 system for short bowel syndrome. The spring-like Eclipse device harnesses mechanotransduction to stimulate growth of new, functional intestinal tissue. Short bowel syndrome is a devastating and rare condition that leads sufferers with too little small intestine to extract sufficient nutrients to sustain life. The grant for Menlo Park, Calif.-based Eclipse came through NIH’s small business innovation program. Read More
The FDA has posted an advisory regarding robotically assisted surgery (RAS) for mastectomy, but the agency also pointedly noted that it is aware of studies underway for such indications without the appropriate oversight. The FDA did not name Intuitive Surgical Inc. in the notice, but the company nonetheless responded to the FDA statement by confirming the absence of any devices thus approved or cleared. The FDA had previously issued a Feb. 28, 2019, advisory stating that the safety and efficacy of RAS devices for mastectomy and the prevention or treatment of breast cancer had not been established. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bioventus, Johns Hopkins University, Merck, Millar, Ontada, Schwarzer Cardiotek, Todos Medical, Trice Medical, University of Washington School of Medicine. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fuse Medical, FX Shoulder, Thermo Fisher. Read More
