DeepX Diagnostics announced today that it received FDA clearance for its DermoSight digital dermatoscope. The DermoSight scope is used for teledermatology screening of suspect skin cancer lesions. Washington-based DeepX Diagnostics plans to enter the U.S. market having already completed more than 180,000 assessments in Europe. FDA clearance for DermoSight covers the acquisition of skin lesions […]
Oncology
Perimeter Medical CEO resigns, board appoints replacement
Perimeter Medical Imaging AI today announced CEO Jeremy Sobotta has resigned, effective June 15, due to personal reasons. The Toronto-based company also announced its board of directors appointed Adrian Mendes at CEO, effective immediately. Sobotta will work closely with Mendes over the next few weeks to ensure a smooth transition of responsibilities. “We are grateful […]
Startup Ezra wins FDA clearance for AI that enhances MRIs
Ezra today announced it received FDA 510(k) clearance for its Ezra Flash AI platform that enhances the quality of MR images. New York-based Ezra designed Ezra Flash to reduce the time needed to complete a high-quality scan with the hopes of reducing MRI costs. The company plans to use the technology to launch what it […]
ABK Biomedical receives FDA IDE for tumor-treating microspheres
ABK Biomedical this week announced it received FDA investigational device exemption approval for its Eye90 microspheres yttrium 90 radioembolization therapy. The FDA IDE approval allows the Halifax, Nova Scotia–based company to commence a multi-center pivotal clinical study in the U.S. involving patients with an especially tough-to-treat form of liver cancer. “FDA approval of this pivotal […]
Data supports DermaSensor skin cancer detection device
DermaSensor announced clinical data validating its handheld, non-invasive device for assisting in the detection of skin cancer. In collaboration with Mayo Clinic and the University of Connecticut School of Medicine, the company presented two studies. One demonstrated the standalone performance of DermaSensor’s novel elastic scattering spectroscopy (ESS) device. The other evaluated the impact of the […]
Innoblative Designs wins FDA breakthrough nod for ablation device
Innoblative Designs announced today that it received FDA breakthrough device designation for its SIRA RFA electrosurgical device. Chicago-based Innoblative Designs designed SIRA for use in breast cancer patients undergoing BCS (lumpectomy). The company plans to present data supporting its breakthrough nod this week. It’s presenting at the Annual Meeting for The American Society of Breast […]
RenovoRx appoints new SVP of clinical operations
RenovoRx (Nasdaq:RNXT) announced today that it appointed Leesa Gentry as senior vice president of clinical operations. Los Altos, California-based RenovoRx said Gentry brings with her “valuable leadership experience” to advance the company’s cancer treatment studies. She becomes the fourth addition to the company’s executive management team in the last year. That group includes COO Angela […]
Illumina to appeal FTC decision on Grail acquisition, aims for resolution by 2024
Illumina (Nasdaq:ILMN) announced today that it plans to appeal the Federal Trade Commission’s (FTC) decision over its acquisition of Grail. The FTC today announced that it finds the $7.1 billion acquisition “likely to substantially reduce competition” in the U.S. It would affect the research, development and commercialization of cancer tests, FTC said. In its decision, […]
HistoSonics announces first kidney tumor treatment with histotripsy
HistoSonics announced the treatment of the first kidney patient using the company’s histotripsy platform in the United Kingdom. Professor Tze Min Wah, senior consultant radiologist and clinical lead for the interventional oncology program at Leeds Teaching Hospitals NHS Trust, performed the procedure. It marks the initial treatment in HistoSonics’ sponsored “CAIN” trial. The Phase I […]
iCad lays off 28% of its workforce in restructuring plan
iCad (Nasdaq:ICAD) announced that it enacted a restructuring plan that includes a workforce reduction of approximately 28%. The Nashua, New Hampshire-based cancer detection and therapy solution developer said that equates to approximately 23 employees. It attributed the restructuring plan to ongoing industry and macroeconomic pressures. iCad’s restructuring aims to support long-term strategic goals and reduce operating […]
Studies back skin cancer detection device from DermaSensor
DermaSensor today presented data from two clinical studies supporting its non-invasive device for evaluating suspicious skin lesions. Miami, Florida-based DermaSensor’s handheld device uses a form of optical spectroscopy called elastic scattering spectroscopy (ESS). It takes noninvasive samples of tissue, capturing cellular-level information. The technology uses hundreds of wavelengths of light in a manner similar to […]