Forsight Robotics Ltd. amassed up to $55 million in series A financing led by Adani Group, with participation by existing investors Eclipse Ventures and Mithril Capital. The new funds will be used to further development of Forsight’s Oryom system, a surgical platform for fully robotic cataract surgery.
The U.S. FDA has granted a breakthrough device designation to Ancora Heart Inc. for its Accucinch ventricular restoration system. The minimally invasive treatment is intended to treat patients with symptomatic heart failure with reduced ejection fraction (HFrEF).
Reflexion Medical Inc. entered into a nonexclusive worldwide licensing agreement with Mirada Medical Ltd., allowing Mirada’s Redengine image registration algorithms to be integrated into Reflexion’s X1 treatment planning software. The algorithms align a patient’s anatomy between distinct imaging modalities or between radiotherapy treatments.
The U.S. FDA has given Sonalasense Inc. a green light to conduct two clinical trials in life-threatening brain tumors using sonodynamic therapy (SDT) and SONALA-001, an intravenous proprietary formulation of 5-aminolevulinic acid, or ALA. The studies – in diffuse intrinsic pontine glioma (DIPG) and recurrent glioblastoma (rGBM) – mark the first time SDT will have been used in clinical trials.
Enovis Corp. reported that it has completed its acquisition of Insight Medical Systems Inc., the developer of a wearable surgical navigation system to enhance surgeon performance during orthopedic procedures. Financial terms of the deal were not disclosed.
Lung cancer claims more lives each year than any other cancer, making early and accurate diagnosis crucial to improving survival rates. To that end, the U.S. FDA has cleared the integration of Intuitive Surgical Inc.’s Ion endoluminal system and Siemens Healthineers AG’s Cios Spin mobile imaging cone-beam CT imaging technology to enhance robotic lung biopsies.
The U.S. FDA gave Envoy Medical Corp. the thumbs up to conduct an early feasibility study of its Acclaim cochlear implant. The fully implanted system, which earned a breakthrough device designation from the FDA, aims to be the first cochlear implant to address hearing loss without the use of any external components.
Adaptive Biotechnologies Corp. launched T-Detect Lyme, a T-cell-based clinical test to detect immune response activated by Borrelia burgdorferi, the bacterial species of spirochete that causes Lyme disease. The CLIA-validated laboratory-developed test (LDT) is meant to help diagnose early Lyme disease in adults showing signs and symptoms of the tick-borne illness.
Resmed Inc. has entered into a definitive agreement to acquire Medifox Dan GmbH, a German developer of out-of-hospital software solutions for providers in major settings across the care continuum, from software and services investor Hg. The deal – valued at roughly $1 billion – is expected to close by the end of the year, which is the end of the second quarter of Resmed’s 2023 fiscal year.
Bright Uro Inc. has emerged from stealth mode with $4 million in seed financing from Academy Investor Network, Fred Moll and several other angel investors. The company also secured a $2 million phase II small business innovation research (SBIR) grant from the NIH.
