RAQA NEWS ROUND UP (SEPTEMBER)

29 September 2019

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GE Healthcare's AI Platform for XRays wins FDA Clearance

 

GE Healthcare has gained FDA 510(k) clearance for its artificial intelligence (AI) algorithms for mobile x-ray devices.

The Critical Care Suite, developed using the company's Edison platform and in conjunction with the University of California San Francisco is designed to reduce the time taken by radiologists to review xrays and diagnose pneumothorax and collapsed lungs. 

"GE Healthcare is leading the way in the creation of AI applications for diagnostic imaging and taking what was once a promise and turning it into a reality. By integrating AI into every aspect of care, we will ultimately improve patient outcomes, reduce waste and inefficiencies and eliminate costly errors. Critical Care Suite is just the beginning" Said GE Healthcare's CEO Kieran Murphy. 

The platform analyses patient images to search for the presence of air in the cavity of the lungs and chest wall (pneumothorax). If the system detects the condition it sends the xray images to the radiologist and notifies the technologist on the device. 

“Currently, 62% of exams are marked ‘STAT’ or for urgent reading, but they aren’t all critical. This creates a delay in turnaround for truly critical patients, which can be a serious issue,” said Jie Xue, president & CEO of X-ray at GE Healthcare. “Not only does Critical Care Suite flag images with a suspected pneumothorax with impressive accuracy and enable radiologists to prioritize those cases immediately, but it also makes AI accessible. Our embedded AI algorithms offer hospitals an opportunity to try AI without making investments into additional IT infrastructure, security assessments or cybersecurity precautions for routing images offsite.”  

FDA Awards Breakthrough Designation for Knee Implant

 

Active Implants has received breakthrough designation statues from the FDA for its NUsurface Meniscus Implant.
The implant is designed for use in patients that still experience pain and discomfort after undergoing knee surgery for torn or damaged meniscus but are not suitable for a complete knee replacement. By more effectively distributing the pressure across the knee joint the implant reduces the amount of discomfort experienced by the patient. 

Ted Davis, president and CEO of Active Implants said: “The Breakthrough Device Designation is a significant step in our mission to fulfil a substantial unmet need in the U.S. orthopaedic market. We believe we will have the data required for our FDA submission next year, after completing enrolment in our clinical trials in 2018. We look forward to working closely with the FDA to expedite the review process for the NUsurface Implant to provide a new treatment option to the hundreds of thousands of patients who continue to experience persistent knee pain following meniscus surgery, but are too young for total knee replacement.” 

The NUsurface Meniscus Implant is the first “artificial meniscus” is already available in Belgium, Germany, Italy and Israel and, if cleared by the FDA, would be the first artificial meniscus in the U.S. 

Breakthrough Nod for Sonic Waves Coronary Device

 

Shockwave Medical has been awarded a breakthrough device designation by the FDA for the device it developed to treat calcified coronary lesions. 

The C2 IVL (intravascular lithotripsy) catheter uses pulsating sonic waves to fracture and breakup calcified plaque and blockages in coronary arteries. Based on a common method to treat kidney stones (lithotripsy), the system delivers a catheter balloon to the affected area where it is filled with fluid and inflated. The balloon then expands and deflates rapidly to create sonic waves which break up the calcium. Once completed the balloon can be re-inflated in order to carry out an angioplasty. 

“Receiving breakthrough device designation is an important milestone, validating IVL as a unique solution for complex calcified coronary disease,” Shockwave president & CEO Doug Godshall said. “Our international customers have responded very positively to Shockwave’s C2 since its commercial launch last year, and our team has been working hard to bring this transformational technology to patients with coronary disease in the United States. We are encouraged that the FDA has determined that Shockwave C2 qualifies as a breakthrough device and we look forward to working collaboratively with the agency so we can make Shockwave C2 available as expeditiously as possible.” 

European CE Mark for Paediatric Heart Devices

 

Abbott has gained European CE Mark approval for its devices to paediatric patients with congenital heart defects (CHD). 

The Masters HP mechanical heart valve and Amplatzer Piccolo Occluder device are designed to treat babies and children when other treatments are found to be unsuitable. The artificial heart valve, measuring only 15mm in diameter, is considered the smallest in the world and mimics the behaviour of a healthy heart valve. 

The occluder is an expanding wire mesh to treat patent ductus arteriosus (PDA) and is guided through to the heart via the vessels, from an incision in the leg.

 “Devices like these are among the best examples of our promise at Abbott to help people live their fullest lives – in this case, young babies and children for whom these treatments are nothing short of miraculous,” Vice President of Abbott’s structural heart business Michael Dale said. “While the children who benefit from these therapies represent a very small segment of the total population with structural heart disease, these advanced technologies enable physicians to treat vulnerable pediatric patients who otherwise have limited options.”