MASSDEVICE ON CALL — This year promises to be a big one for medical device legal battles, as bellwether trials for several high-profile device disputes are slated for later in 2013.
Women's Health
Past repeat CTs may increase breast cancer risk | MassDevice.com On Call
MASSDEVICE ON CALL — Repeated computed tomography testing in the past may increase a woman’s chances of developing breast cancer in the future, according to a new study from the Radiological Society of America.
Mixed messages on the merits of mammograms
The latest published research on mammogram use and breast cancer trends in the U.S. offered mixed messages for women who must navigate betwen the dangers of missing mammograms as well as for getting over-treated as a result of them.
A new study released by the Radiological Society of North America warned that new federal recommendations regarding breast cancer screening could result in skipped mammograms and missed cancers.
Dune Medical lands conditional approval for MarginProbe breast cancer screening tool
Framingham, Mass.-based Dune Medical Devices inched closer to premarket approval from the FDA for its MarginProbe breast cancer detection tool, winning an "approvable letter" from the federal watchdog agency.
The company is working together with the FDA on the design of the required post approval study for the MarginProbe system, the final step before Dune can commercialize the product in the U.S., according to the approvable letters.
Hologic guides low for 2013, expecting $25M impact of the device tax
Halt Medical lands FDA nod for game-changing uterine fibroid treatment
Women’s health devices maker Halt Medical announced a U.S. regulatory win for its game-changing uterine fibroid treatment, providing an alternative for women who refuse hysterectomy.
"Acessa is the 1st product cleared anywhere in the world that can be used by gynecologists to treat all fibroid symptoms and types," Halt CEO Jeffrey Cohen said in prepared remarks.
Philips in India: Screening under-served women for cervical, breast cancer
Philips Healthcare (NYSE:PHG) threw its support behind a long-term program to provide screening and preventative care to women in under-served areas of India after a pilot program proved successful.
Research: MindChild and Oxford agree to work on fetal and maternal monitoring
North Andover, Mass.-based startup MindChild Medical landed a research partnership with Oxford University dedicated to developing signal processing software with MindChild’s Meridian, a non-invasive fetal heart rate data monitor.
French breast implant scandal chief released from jail | MassDevice.com On Call
MASSDEVICE ON CALL — French medical device CEO Jean-Claude Mas was freed from prison and is awaiting trial after he admitted that he allowed his company to use substandard silicone in breast implants.
AirXpanders lands CE Mark approval for breast tissue expansion system
Palo Alto, Calif.-based breast reconstruction company AirXpanders received European CE Mark approval for its AeroForm device, a needle-free and patient-controlled tissue expansion system.
The AeroForm system uses carbon dioxide, released by the patient using a wireless remote control unit, to stretch skin and muscles to create space for a permanent breast implant.