AngioDynamics (NSDQ:ANGO) today announced the FDA has approved its investigational device exemption application for its NanoKnife irreversible electroporation pilot study. The non-randomized pilot study will include six subjects at up to three sites and is designed to inform the design of a pivotal clinical study in the U.S. to help support the company’s bid for pre-market […]
Report: Google AI improves lung cancer diagnosis accuracy
Google (NSDQ:GOOG) has unveiled a new artificial intelligence system that outperformed six radiologists in detecting lung cancer, identifying 5% more cancers and cutting false positive rates by 11%, according to a STAT News report. The system was trained on 42,000 computed tomography scans taken in a National Institutes of Health clinical trial, according to the report. […]
Varian Medical to pick up Cancer Treatment Services Int’l for $283m
Varian Medical (NYSE:VAR) said today that it inked a deal to acquire Cancer Treatment Services International for $283 million. Privately held CTSI operates the Hyderabad-based American Oncology Institute and 10 multidisciplinary radiation, medical and surgical oncology cancer centers across the Indian subcontinent and a U.S.-based oncology solutions division, Palo Alto, Calif.-based Varian said. Varian said that […]
Check-Cap signs second trial site, beats Street on Q1 loss
Check-Cap (NSDQ:CHEK) said today that Mayo Clinic (Rochester, Minn.) has signed on as the second trial site in the U.S. pilot study of the company’s C-Scan colorectal cancer-screening system. The single-arm study to evaluate the safety and usability of the X-ray-enabled, cancer-screening capsule will enroll up to 45 adults considered to be at average risk […]
AngioDynamics wins IRB approval for Stage 3 pancreatic cancer NanoKnife study
AngioDynamics (NSDQ:ANGO) said yesterday that it won central Institutional Review Board approval to run a clinical study of its NanoKnife irreversible electroporation system seeking an indication for use in treating Stage III pancreatic cancer. The Lantham, N.Y.-based company said that the approval will accelerate its engagement with local IRBs and will hasten its DIRECT clinical study. […]
Elucent Medical wins FDA nod for EnVisio breast surgery navigation device
Elucent Medical said today that it won FDA 510(k) clearance for its EnVisio surgical navigation system. The Eden Prairie, Minn.-based company said that the EnVisio navigation system is designed for use in conjunction with the company’s SmartClip soft tissue marker during breast cancer procedures. The SmartClip soft tissue marker is an alternative to hook-wire localization […]
Australia’s TGA considering, but not yet implementing, textured breast implant ban
Australia’s TGA said yesterday that it is seeking new data from suppliers of textured breast implants, which have been linked to a rare immune-system cancer, before making a decision on whether or not to suspend or cancel those products from its Register of Therapeutic Goods. The regulatory body gave suppliers of the devices 10 working […]
Varian Medical joins embolic therapy tech dev ABK Biomedical’s $30m Series B
Varian Medical (NYSE:VAR) has joined a $30 million Series B round of financing for embolic therapy tech developer ABK Biomedical. Palo Alto, Calif.-based Varian Medical Systems led the round alongside F-Prime Capital, Halifax, Nova Scotia-based ABK Biomedical said. “ABK has a unique approach to address a large unmet need for patients with non-resectable liver tumors. This […]
AirXpanders touts study results
AirXpanders (ASX:AXP) said that a retrospective clinical study has concluded that the use of its AeroForm tissue expanders may be associated with reduced infection rates, less medical treatment and lower costs for patients and health systems. The Palo Alto-based company makes the AeroForm tissue expander for post-mastectomy breast reconstruction. The device is designed to expand and […]
FDA wants to update mammography standards
The FDA today issued a proposed rule that would modernize mammography quality standards and require mammography facilities to provide more information to patients and healthcare providers. The proposed rule would be the first update in 20 years, amending regulations issued under the Mammography Quality Standards Act of 1992, which authorizes FDA oversight over mammography facilities, […]
FDA Panel: Too early to pull textured breast implants over cancer risk, need more data
A panel of experts convened by the FDA yesterday said that there’s not enough data to pull textured breast implants from the market over concerns that they may be linked to a type of immune system cancer, according to an AP News report. The recommendation comes from the first day of a two-day panel meeting […]
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