Accuray (NSDQ:ARAY) announced that it promoted executive Suzanne Winter to president, effective as of July 1, 2021. Winter, who previously served as Sunnyvale, Calif.-based Accuray’s chief commercial officer and SVP of R&D & medical & scientific affairs, will continue to report to CEO Joshua Levine. “Suzanne has had a significant impact on Accuray’s product portfolio […]
Oncology
Onkos Surgical wins FDA clearance for BioGrip 3D-printed implant
Onkos Surgical today announced that it received FDA 510(k) clearance for its BioGrip 3D-printed implant technology. The Parsippany, N.J.–based company designed BioGrip to address the clinical challenge of aseptic loosening in musculoskeletal oncology and complex orthopedic limb salvage surgery. It helps provide bone ingrowth at the bone-implant interface. Get the full story on our sister […]
Latest iCad 3D mammography AI gains CE mark
iCad (NSDQ:ICAD) today announced that the third version of its ProFound AI for digital breast tomosynthesis (DBT) has won CE mark approval. Compared with previous software versions, the latest generation of ProFound AI offers up to a 10% improvement in specificity performance while maintaining a high sensitivity level, and approximately 40% faster processing on the new […]
Cardinal Health wins new FDA approval for Lymphoseek
Cardinal Health (NYSE:CAH) announced today that the FDA approved its Lymphoseek injection for pediatric use. Dublin, Ohio-based Cardinal Health touts Lymphoseek — acquired from Navidea Biopharmaceuticals (NYSE:NAVB) in November 2016 — as the first and only radiopharmaceutical agent specifically designed for targeted lymphatic mapping and guiding sentinel lymph node biopsies (SLNB). Get the full story at our […]
FTC drops Illumina-Grail court case, clearing the way for EU investigation
A U.S. judge has ruled in favor of an FTC petition to drop its case against the proposed merger between Illumina (NSDQ:ILMN) and Grail. The Financial Times reported that the ruling — with dropped the case without prejudice — allows the EU to investigate the merger while the deal remains blocked. In April the European Commission’s […]
Lucid Diagnostics gains CE mark for esophageal device
Lucid Diagnostics has received the CE mark for its EsoCheck esophageal cell collection device, its parent company announced today. EsoCheck is an FDA-cleared, swallowable balloon capsule catheter that enables a clinician to sample surface cells from the esophagus in a less than five-minute, non-invasive office procedure. Lucid touts EsoCheck as the only such device capable of […]
Ibex AI-enabled breast cancer diagnostic lands CE mark
Ibex Medical Analytics announced today that it received CE mark approval for its Galen AI-based breast cancer diagnostic platform. Tel Aviv, Israel–based Ibex’s Galen platform uses AI and machine learning technology based on hundreds of thousands of image samples scanned from biopsy slides through digital pathology, according to a news release. Galen previously won CE […]
This imaging device could be a breast cancer treatment breakthrough
OncoRes Medical’s system may detect cancer cells on a microscopic scale during a lumpectomy, potentially averting the need for a second breast cancer surgery. Having breast surgery to remove a cancerous lump is traumatic enough. Learning that you’ll need another operation to remove cancer cells that the surgeon couldn’t detect the first time only adds […]
Delcath Systems ticks up despite missed Q1 projections
Delcath Systems (OTC:DCTH) shares ticked up slightly despite first-quarter results that missed the consensus forecast. The New York-based company posted losses of -$6.7 million, or -$1.04 per share, on sales of $388,000 for the three months ended March 31, 2021, for a -33% bottom-line slide on sales growth of 32%. Delcath’s EPS of -$1.04 came […]
Avenda Health wins FDA breakthrough nod for AI-based prostate cancer treatment
Avenda Health announced today that it received FDA breakthrough device designation for its AI-based male “lumpectomy” product. Santa Monica. Calif.-based Avenda designed its lumpectomy product to treat prostate cancer in-office while preserving the quality of life through AI and minimally invasive technologies, according to a news release. The Avenda Health focal therapy system spares healthy […]
BWXT Medical to make TheraSphere microspheres for Boston Scientific
BWXT Medical announced today that it entered into a long-term, mutually exclusive agreement to manufacture Boston Scientific’s TheraSphere. Ottawa, Ontario-based BWXT’s new deal with Boston Scientific covers manufacturing of the TheraSphere Y-90 glass microspheres from the Marlborough, Mass.-based medtech company. TheraSphere treatment for patients with hepatocellular carcinoma (HCC) delivers millions of glass microspheres containing radioactive […]
