Cable-free fetal monitoring system
The Avalon CL is the first cable-free monitor to incorporate Philips’ patented Smart Pulse technology, which allows the system to discern between the heart rates of mother and fetus, (as well as between twins and triplets). With the new system, a mother can even take a shower or lie in a bath tub while being monitored just as precisely as if she were stuck in the delivery bed with a tethered system. That alert enables timelier intervention and better outcomes. The Avalon CL received FDA 510(k) clearance the day before Thanksgiving, but Philips elected to withhold the news until their sales team had been properly trained and the busy holiday season had passed.




Minimally invasive biopsy device
Intact Medical Corporation, a minimally invasive device company, announced that its Intact system received expanded FDA clearance. It has been approved for removing breast lesions up to 30 millimeters in diameter, while preserving the lesions’ architectural integrity for diagnostic assessment. A procedure using Intact can be performed in a physician’s office and takes less than 20 seconds. During the procedure, a six to eight millimeter incision is made and the Intact wand targets the lesion with the help of image guidance. The wand then encompasses the lesion in less than 10 seconds, and then the physician extracts it.


DR System
A new version of Siemens Multix Fusion DR System offers two-detector X-ray technology for smaller-budget facilities, and has just been approved by the FDA. The system — which is essentially the same as the version approved in 2012 except for the number of detectors — supports the full spectrum of routine radiography and features digital cassette-sized flat-panel detectors, a large fixed detector in the wall stand, a height-adjustable table with a 660 pound capacity, and a touch screen positioned at the overhead tube suspension for exam parameter changes at the patient’s side.


Breast CT scanner
Koning Corporation’s Koning Breast CT (KBCT) system and KBCT-guided biopsy bracket have received FDA approval. The company says that it is the first 3-D breast CT scanner on the market that images the whole breast in a single scan without requiring compression. The procedure is more comfortable than mammography because the breast isn’t compressed and less radiation is administered to the patient since only the breast is exposed to the X-rays, according to a 2014 FDA statement.


Bladder scanner
dBMEDx, a wireless medical device company, recently announced that it received FDA approval for its new bladder scanner, BBS Revolution. The scanner non-invasively measures bladder volume so physicians can decide whether a patient needs a urinary catheter. It works by combining ultrasound technology with image processing electronics and software.