Delcath Systems (Nasdaq:DCTH) announced today that it entered into a securities purchase agreement worth $7 million in proceeds. The company entered into an agreement with certain accredited investors for the private placement. The collection of investors includes existing investors, Delcath executives and members of the board of directors. Delcath plans to issue and sell 876,627 […]
Oncology
SafeGuard Surgical wins FDA breakthrough nod for biodegradable stent backed by NFL QB
SafeGuard Surgical announced today that the FDA granted breakthrough device designation to its LeakGuard biodegradable stent. Along with the regulatory milestone, the company announced that it completed its Series A funding round. Tom Pepin, principal at Tapper Ventures, led the financing. NFL quarterback Jameis Winston is also one of the first investors in the company. […]
Autonomix completes first procedures in pancreatic cancer ablation trial
Autonomix Medical announced today that it completed the first three patient procedures in a proof-of-concept trial of its ablation technology. The Woodlands, Texas-based Autonomix designed its transvascular radiofrequency (RF) ablation technology to treat pancreatic cancer pain. Current approaches to treat this pain include opioids or ethanol injections. However, Autonomix says those approaches may only provide […]
Philips, AWS expand partnership on digital pathology in the cloud
Philips today announced an expanded partnership with Amazon Web Services (AWS) based around digital pathology in the cloud. The two initially linked up about a year ago, inking a deal to develop generative AI applications. This partnership centered around Philips’ imaging archiving and communications system. It wasn’t the first time a medtech giant linked up […]
Lumicell earns positive FDA panel decision on surgical imaging tool, approval decision expected soon
Lumicell announced that an FDA advisory committee voted in support of the benefit-risk profile of its LumiSight offering. LumiSight, an optical imaging agent, works in combination with the Lumicell direct visualization system (DVS) in breast cancer imaging. The combination product — a fluorescence-guided surgical imaging tool — detects residual cancer in real-time during a lumpectomy. […]
GE Healthcare’s AI models can predict patient responses to immunotherapy
GE HealthCare today announced data showing its AI models’ ability to accurately predict patient responses to immunotherapies. The study collected clinical data to accurately forecast the effectiveness and toxicity of cancer immunotherapy. Data demonstrated accuracy between 70% and 80% with the AI models in a pan-cancer cohort. Investigators published outcomes in the Journal of Clinical […]
Medtronic wins FDA clearance for bone tumor ablation tech
Medtronic announced today that it received FDA 510(k) clearance for its OsteoCool 2.0 bone tumor ablation system. The medtech giant designed OsteoCool 2.0 to treat painful bone metastases and benign bone tumors like osteoid osteoma. The minimally invasive procedure uses probes to deliver radiofrequency energy that heats and destroys tumors. Meanwhile, it circulates water to […]
FDA clears surgical guidance system from Merit Medical
Merit Medical Systems (Nasdaq:MMSI) announced today that it received FDA 510(k) clearance for the Scout MD surgical guidance system. Scout MD broadens the South Jordan, Utah–based company’s oncology portfolio. Merit designed the system to enhance the diagnosis and treatment of breast cancer, as well as other soft tissue cancers. The system includes the Scout radar […]
Vessi Medial raises $16.5M for cryotherapy for bladder cancer
Vessi Medical announced today that it closed a Series A financing round worth $16.5 million to support its cryotherapy technology. Misgav, Israel-based Vessi develops its technology to treat non-muscle invasive bladder cancer (NMIBC). It could provide a therapeutic alternative to transurethral resection of bladder tumor (TURBT), the current first-line therapy. Vessi believes its bladder-specific, proprietary […]
Carthera enrolls first patient in ultrasound drug delivery trial
Carthera announced today that it enrolled the first patient in the SONOBIRD pivotal trial for its SonoCloud device. Paris, France-based Carthera designed SonoCloud to treat a wide range of brain disorders. The device emits ultrasound to temporarily increase the permeability of blood vessels in the brain, improving therapeutic molecule delivery. After implantation in the skull, […]
FDA to reassess cryoablation tech for destroying tumors from IceCure Medical
IceCure Medical (Nadsaq:ICCM) announced today that the FDA responded affirmatively to a request for supervisory review. This follows the agency’s 2022 denial of IceCure’s de novo classification request for its ProSense cryoablation system. The Caesarea, Israel-based company sought clearance for ProSense to treat patients with early-stage, low-risk breast cancer. FDA’s affirmative response reopens the de […]