RaySearch Laboratories issued an urgent field safety notice in Europe to warn on an issue with the dose calculation for the Siemens (NYSE:SI) virtual wedge in several of RaySearch’s RayStation treatment planning systems. The affected RayStation models listed in the safety notice out of Germany included RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), […]
CMS recommends postponing most elective procedures
The Centers for Medicare and Medicaid Services (CMS) released guidance late yesterday asking healthcare providers to postpone adult elective surgeries and procedures, including dental procedures, until further notice. The move is an attempt to preserve the supply of ventilators and personal protective equipment such as masks and gowns while protecting patients and staff from exposure […]
J&J’s Janssen, Thermo Fisher Scientific to collaborate on oncology diagnostic
Thermo Fisher Scientific (NYSE:TMO) announced today that it entered into an agreement with Johnson & Johnson‘s (NYSE:JNJ) Janssen Biotech to co-develop a companion diagnostic (CDx) in oncology. Under the agreement, Thermo Fisher is set to collaborate with Janssen’s R&D scientists to validate biomarkers for use with Thermo Fisher’s Oncomine DX target test in identifying variant-positive patients for […]
Adaptiiv Medical Technologies raises $1.8m
Adaptiiv Medical Technologies filed an amendment to its SEC Form D to confirm the sale of nearly $1.8 million in an equity offering. The Halifax, Nova Scotia-based cancer treatment software developer sold about $1.79 million in the $3 million offering, leaving just over $1.2 million remaining to be sold. Adaptiiv made the first sale on […]
Ibex wins CE Mark for AI-powered cancer detection software
Ibex Medical Analytics announced today that it won CE Mark approval for its artificial intelligence-powered Galen Prostate software for identifying suspected cancer on prostate core needle biopsies. Tel Aviv-based Ibex touts its Galen prostate solution as the first-ever AI-based software for cancer detection used in routine clinical practice, and it is already deployed in pathology […]
Pavmed gains FDA breakthrough nod for esophageal pre-cancer test
Pavmed (NSDQ:PAVM) recently announced that its Lucid Diagnostics subsidiary has received FDA breakthrough device designation for its EsoGuard esophageal DNA test. The test uses esophageal samples collected using Lucid’s 510(k)-cleared EsoCheck cell collection device from certain patients at elevated risk for esophageal dysplasia due to chronic gastroesophageal reflux disease (GERD). EsoGuard and EsoCheck are designed to […]
FDA recommends limiting use of power morcellators
The FDA today recommended that laparoscopic power morcellators, which have been implicated in the spread of cancer, be limited to use with certain tissue containment systems and only in premenopausal women under 50 years of age. Power morcellators were used for 20 years to laparoscopically remove benign tumors of the uterus, known as fibroids, by mincing them. […]
FDA clears Varian’s AI-driven radiation therapy
Varian Medical Systems (NYSE:VAR) announced today that it won FDA 510(k) clearance for its Ethos AI-driven adaptive intelligence solution for cancer care. Ethos is designed to offer an adaptive treatment based on the patient’s anatomy and position to better target the tumor, reduce the dose to healthy tissue and improve overall outcomes within a 15-minute time […]
Aethlon Medical completes $3.8m offering
Aethlon Medical (NSDQ:AEMD) announced that it completed its previously announced registered direct offering of nearly 1.9 million shares of its common stock for nearly $3.8 million in proceeds. The shares, offered at a purchase price of $2 per share, totaled approximately $3.77 million in gross proceeds. Aethlon additionally issued unregistered warrants to purchase up to 942,689 […]
Varian appoints VP of clinical affairs
Varian Medical Systems (NYSE:VAR) yesterday said it appointed Dr. Ricky Sharma as VP of clinical affairs. Sharma will be responsible for leading medical research, translational science and clinical trials for the company’s oncology business. He will report to chief medical officer and senior VP of medical affairs Dee Khuntia. “Dr. Sharma is an international authority on […]
ArcherDX wins breakthrough nod for personalized cancer monitoring tech
ArcherDX announced that it has won breakthrough device designation from the FDA for its personalized cancer monitoring (PCM) technology. Boulder, Colo.-based ArcherDX’s PCM platform is designed for minimally invasive monitoring and recurrence surveillance for early-stage cancer treatment. It is meant to offer healthcare providers access to genomic information in their laboratory. ArcherDX also recently won […]
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