1. FDA clears LifeSignal’s wireless ECG
LifeSignals announced in a July 26 press release that it has received FDA clearance for its wireless LP1100 Life Signal Patch. The patch is designed to be used in wearables and healthcare monitoring devices. The clearance allows the company to use the Life Signal Processor to develop ECG and other vital sign monitoring wearables with wireless connection to the cloud. It also gives OEMs a biosensor patch for companies that are looking to deliver certain health applications in a low acuity patient monitoring space, consumer wellness, senior care and animal health.
2. DoseOptics launches radiotherapy beam imaging system
DoseOptics has launched its radiation beam imaging system known as the C-Dose Research, according to a July 25 press release. C-Dose enables direct imaging of radiation delivery on a routine basis. It captures both photon and electron beam delivery and can be installed as a fixed ceiling mounted device or on a tripod. It also offers imaging for QA development or human research with a customized visual display and archiving software that matches the workflow of a radiotherapy department.
3. FDA clears Flashback’s blood loss monitor
Flashback Technologies announced in a July 26 press release that it has received FDA 510(k) clearance for its CipherOx CRI M1 monitor. The monitor is a handheld device that non invasively calculates and displays heart rate, SpO2 and the compensatory reserve index (CRI). The CipherOx CRI M1 monitor displays CRI as a fuel gauge that rises and falls based on whether a patient is losing volume by bleeding or gaining volume from active fluid resuscitation. The accompanying screen shows the instantaneous CRI value, a 20-minute trend graph, HR and SpO2 values. Flashback Technologies’s new device is battery powered and developed for pre-hospital and hospital settings.
4. FDA approves Health.io’s smartphone home urinalysis test
Healthy.io announced that it has received Class II FDA approval for its Dip.io product, according to a July 25 press release. Dip.io is a home-based, smartphone-enabled urinalysis kit that allows patients to conduct clinical grade urine tests from their home. The company says that it is the first time the FDA has ever granted a Class II approval for smartphone urine testing.
5. FDA clears FBC Device’s spinal alignment implant
FBC Device announced in a July 24 press release that it has received FDA clearance for its spinal interbody implant. The implant provides lordosis adjustment from 9 to 21 degrees to help surgeons and patients with back pain and disability.
6. Medi-Lynx Cardiac Monitoring wins FDA nod for PocketECG
Medi-Lynx Cardiac Monitoring has received FDA 510(k) clearance for its PocketECG Cardiac Rehabilitation System according to a July 23 press release. The device is a mobile cardiac rehabilitation system that is designed to provide high-quality ECG monitoring and automated arrhythmia detection during rehabilitation training. It monitors a patient’s heart rhythm and heart rate during rehabilitation exercise to guide the intensity and duration of specific workouts in real-time. The device features a built-in accelerometer that allows clinicians to analyze the impact of physical activity on heart rate.
7. Zavation wins FDA nod for Normandy VBR corpectomy cage
Zavation announced in a July 17 press release that it has received FDA 510(k) clearance for its Normany VBR System. The system is a cervical and thoracolumbar expandable corpectomy cage with an adjustable height to provide structural stability in skeletally mature patients following a corpectomy or vertebrectomy. The system features spacers of different sizes to fit the anatomical needs of a variety of patients. The height can be adjusted after implantation as well. It is mechanically locked at the required height by a locking screw and each spacer has an axial hole to allow autograft or allograft to be packed in each spacer.