Oncology
AngioDynamics lands 510(k) for BioFlo Port
AngioDynamics (NSDQ:ANGO) roped in another FDA win for its BioFlo device, the 2nd clearance for a product line the medical device company picked up through its $372 million Navylist buyout.
White House has missed half of ACA deadlines | MassDevice.com On Call
MASSDEVICE ON CALL — During the 1st 3 years of Affordable Care Act implementation, the Obama administration has failed to meet half of its mandatory deadlines, according to a new report from the non-partisan Congressional Research Service.
Diabetes: Do smartphones fit the bill for the next mobile artificial pancreas? | MassDevice.com On Call
MASSDEVICE ON CALL — Smartphones are capable of meeting all the criteria for an artificial pancreas by providing close-loop, outpatient control of glucose levels for diabetics, according to a new study published by the American Diabetes Assn.
GPOs: Premier inks new supply contracts
Group purchasing organization Premier Healthcare Alliance inked a pair of new contracts with U.S. medical device companies.
Deals for oral care products went to Kimberly-Clark (NYSE:KMB) and to hospital supplies company Sage Products.
Digirad sells imaging technology to Novadaq for $2 million
Digirad Corp.(NSDQ:DRAD) handed over several on-the-shelf and in-development devices to Novadaq (TSE:NDQ) in a $2 million deal that includes 5 pending patent applications and the rights to 13 existing technologies.
NeuWave Medical zeros in on $19M in equity financing
Wisconsin medical device maker NeuWave Medical is more than halfway to wrapping up a hoped-for $19 million equity funding round, with $14 million in the bank so far and 22 accredited investors, according to an SEC filing.
The new filing offered more details on a fundraising round that began almost 1 year ago. As of yesterday, the ablation device company has about $5 million left to go to top off the fund-raise.
GE submits PMA for extended labeling for Senographe mammography
GE Healthcare (NYSE:GE) is hoping to extend FDA premarket approval for its Senographe Essential system to adds on 3D breast imaging, or tomosynthesis, to the device’s approved indications.
Insightec lands Chinese approval for ExAblate ultrasound tumor ablation
Israeli device maker InSightec landed a green light from the Chinese Food & Drug Administration for its ExAblate MRI-guided focused ultrasound therapy, with an indication to treat non-cancer-causing tumors in the uterus.
These tumors, called uterine fibroids, occur in more than 20% of women of childbearing age, according to the company. ExAblate is an incision-free treatment that uses ultrasound frequencies to ablate tumors.
Routine lung cancer screening gets federal panel’s OK for the 1st time
The U.S. Preventive Services Task Force made waves this week when it recommended for the 1st time that certain patients undergo annual low-dose CT scanning for lung cancer, paving the way for insurance companies to cover the tests.
Varian struggles in Japan in Q3, adjusts full-year guidance
Varian Medical Systems (NYSE:VAR) got a little Wall Street love today, despite reporting significant Q3 headwinds that spurred an adjustment of the company’s full-year guidance.