1. Angiodroid wins CE Mark for Angiopulse IABP
Angiodroid announced in a July 11 press release that it has received CE Mark approval for its AngioPulse intra-aortic balloon pump device. The AngioPulse uses a new system for intra-aortic balloon pumps based on pressure regulation. It is designed for weaning solutions and is suitable for all types of patients needing intra-aortic balloon pump therapy.
2. Visura Technologies wins FDA nod for disposable TEE camera
Visura Technologies has received FDA 510(k) clearance for its TEE Camera Assist Device (TEECAD), according to a July 10 press release. The TEECAD has a single-use disposable camera that can be easily attached to a transesophageal echocardiogram (TEE) ultrasound probe to give physicians a view of the upper airway and esophagus during probe placement for a safe intubation process. The camera view can be viewed from a separate viewing system display to see real-time images from the camera.
3. FDA clears Oculocare’s Alleye wet AMD monitor
Oculocare announced in a July 9 press release that it has received FDA 510(k) clearance for its Alleye mobile medical software application. Alleye is designed to be used for detecting and monitoring age-related macular degeneration. It detects and characterizes central and paracentral metamorphopsia in patients who have macular conditions like AMD and diabetic retinopathy. Alleye gives patients the chance to regularly perform simple self-tests at home to help monitor eyesight or assess disease progression.
4. FDA clears RedDress’s RD1 blood clot wound treatment
RedDress has received FDA 510(k) clearance for its RD1 System, according to a July 10 press release. The RD1 System is a wound care product that helps healthcare providers produce in vitro whole blood clots in real time for chronic wound care. It is intended to be used at point-of-care for a safe and quick preparation of whole blood clot from a small sample of a patient’s own peripheral blood. It is topically applied for the management of exuding cutaneous wounds like leg ulcers, pressure ulcers, diabetic ulcers and mechanically or surgically-debrided wounds. The RD1 System is to be used under the supervision of a healthcare professional.
5. Lipogems receives FDA nod for microfragmented adipose tissue transplant system
Lipogems announced in a July 5 press release that it has received FDA 510(k) clearance for its Microfragmented Adipose Tissue Transplant System. The system is designed to be used in orthopedic and arthroscopic procedures. The technology uses the body’s own fat to help in the healing process. The procedure can be performed in an office or surgical setting in just under one hour. Lipogem’s system uses saline to rinse and remove contaminants like oil, blood and cell debris from harvested fat. Then the system can resize the tissue to an optimum size to retain the fat tissue’s natural and beneficial properties.
6. FDA clears Healcerio’s Sonon 300L handheld ultrasound
Healcerion has received FDA approval for its Sonon 300L handheld ultrasound device, according to a July 9 press release. The device offers flexible ultrasound technology and a tenth of the cost of a traditional ultrasound machine. The Sonon 300L interface can be learned by anyone in minutes. It can be used anywhere with a smartphone app that can be downloaded to Apple and Android devices. When paired with a tablet or smartphone, images can be analyzed and shared quickly through the display. The device weighs 13 ounces and has a rechargeable lithium-ion battery, Wi-Fi connectivity and 3G/LTE cellular capability.
7. Masimo launches vital signs app for Root system
Masimo announced in a July 9 press release that it has launched its Vital Signs Check Applications for its Root patient monitoring and connectivity platform. It is available for new and existing Root customers through a software upgrade. Root Vital Signs Check allows clinical to streamline vital signs measurement workflows while optimizing patient data management, according to the company. It has early warning scores, centralized data collection using a single device, immediate electronic charting at the bedside and automated patient association.