Mauna Kea Technologies (ENT:MKEA) landed FDA clearance for its AQ-Flex 19 mini-probe, which is already on the market in Europe. The device is designed to biopsy pancreatic cysts during endoscopic needle aspiration procedures in the digestive tract.
Oncology
Varian slides amid uncertainty in U.S. and E.U. oncology markets
Varian Medical Systems (NYSE:VAR) was none too pleased with the market for its oncology systems, calling its Q2 revenues for that division "disappointing, particularly in the U.S."
Recall: Accuray explains caution on CyberKnife radiosurgery system
Women’s health cancer diagnostics company DySIS Medical raises $9.7M
Women’s health company DySIS Medical touted a $11.3 million (£7.4 million) fundraising round in support of its diagnostic devices.
The Scotland-based medical device maker hopes to expand market reach in Europe and the U.S. for its DySIS colposcope, an imaging device that painlessly assesses the condition of the cervix. The device already has CE Mark as well as regulatory approval from the FDA.
FDA accepts Edap’s Ablatherm PMA application
Edap (NSDQ:EDAP) said the FDA accepted its pre-market approval application for its Ablatherm ultrasound prostate cancer treatment, backed by data from its Enlight investigational device exemption study.
The Vaulx-en-Velin, France-based medical device company also reported that its losses increased by a whopping 646% during the 2012, on an 8% sales increase.
The pros and cons of prostate cancer screening | MassDevice.com On Call
MASSDEVICE ON CALL — The debate over prostate cancer screening took a rather conservative step forward this month with the American College of Physicians recommending that doctors only provide screenings to well-informed patients who’ve opted for a prostate-specific antigen, or PSA, test.
Cancer: FDA approves Navidea’s Lymphoseek imaging agent
The FDA approved Navidea Biopharmaceuticals’ Lymphoseek radioactive imaging agent, an injectable drug that helps physicians isolate lymph nodes in patients with breast cancer or melanoma.
The Lymphoseek approval marks the 1st time in more than 30 years that the FDA has approved a lymph node mapping drug, according to an agency notice.
Premier healthcare alliance awards new radiation treatment system contract to member hospital
Group purchasing organization Premier inked a contract with Philips Healthcare (NYSE:PHG) for radiation treatment planning.
Holaira raises $10M for lung device | Wall Street Beat
Medical device company Holaira said it drummed up $10 million, changed its name and moved its headquarters.
Formerly known as Innovative Pulmonary Solutions, Holaira said it plans to use the Series C round to develop its minimally invasive devices to treat obstructive lung disease. All of Holaira’s existing backers participated, namely Advanced Technology Ventures, Morgenthaler Ventures, Split Rock Partners, and Versant Ventures.