Abbott Laboratories received U.S. FDA approval for its Esprit below-the-knee (BTK) everolimus-eluting resorbable scaffold system for use in chronic limb-threatening ischemia well ahead of the expected second half 2024 time frame. Esprit showed clear superiority to angioplasty in the LIFE-BTK trial presented at last year’s Transcatheter Cardiovascular Therapeutics conference and published in The New England Journal of Medicine.
In March, the U.S. FDA reported a major shortage of Rhogam, the anti-D immune globulin most widely used to prevent Rh factor incompatibility in pregnancy. Without treatment, second and subsequent pregnancies can be endangered by antibodies created by the mother. With the shortage, the standard treatment of two shots for all pregnant females with Rh-negative blood can be challenging, but Billiontoone Inc.’s Unity prenatal test can eliminate the need for the immune globulin treatment in 40% of these pregnancies.
Hyperfine Inc. aims to simplify monitoring of potentially dangerous adverse events associated with amyloid-targeting therapies with the launch of its Capturing ARIA Risk Equitably with Portable MR observational study. The study will evaluate the benefits of the Swoop portable brain MRI system in acquiring images needed to detect amyloid-related imaging abnormalities in Alzheimer’s patients as specified in product labeling.
Expanse Ice Inc. received U.S. FDA clearance for its Ice Aspiration system, which is designed to clear blood clots in peripheral vessels. The system uses distal cyclical aspiration to “harness the aspiration power typical of a large bore catheter, but within the slender profile of a much smaller device,” Expanse Founder and CEO Eitan Konstantino said.
Lumicell Inc. sees a brighter future now that it has secured U.S. FDA approval for both its new drug application for Lumisight (pegulicianine) optical imaging agent and premarket approval for the Lumicell direct visualization system.
Quest Diagnostics Inc. expanded its Alzheimer’s disease (AD) portfolio with a blood-based biomarker test for phosphorylated tau 217 (pTau217). The test joins the company’s plasma tests for p-tau181, beta-amyloid 42/40 ratio and ApoE genetic risk as well as several cerebrospinal fluid tests for Alzheimer’s.
Lumicell Inc. sees a brighter future now that it has secured U.S. FDA approval for both its new drug application for Lumisight (pegulicianine) optical imaging agent and premarket approval for the Lumicell direct visualization system . The company markets the two together as the Lumisystem to detect and resect residual breast cancer. Newton, Mass.-based Lumicell expects the Lumisystem will be available in the fourth quarter of 2024, Lumicell President and Chief Operating Officer Howard Hechler told BioWorld.
Bruker Corp. shows no sign of slowing its buying binge, picking up Nanostring Technologies Inc. for $392.6 million in cash plus the assumption of certain liabilities in its seventh deal so far this year.
Nanostring entered bankruptcy in February and received a “stalking horse” bid of $220 million from private equity fund Patient Square Capital in March. Bruker won the competitive auction for Nanostring’s assets, besting the Patient Square bid by 78%. The deal is expected to close in early May.
Butterfly Network Inc. expanded its collaboration with the Clinton Health Access Initiative, Global Ultrasound Institute and the Bill & Melinda Gates Foundation to increase access to maternal/fetal ultrasound technology. The program will bring 500 IQ+ systems and ultrasound training to six provinces in South Africa, following a successful introduction in late 2022 in Kenya.
Vomaris Inc. introduced its U.S. FDA-cleared Powerheal bioelectric bandage for over-the-counter use following studies showing a shocking 99.99% reduction in bacteria present in wounds covered with the bandage even without the use of antibiotics. The bandage’s electrical energy also stimulates cell movement, cutting healing time in half, a study found.
