Scopio Labs, a leading provider of Full Field Morphology (FFM), announced that it was granted FDA clearance to market and sell its X100 with Full Field Peripheral Blood Smear (Full Field PBS) Application, unlocking the potential of in vitro hematology diagnosis. Full Field PBS is also available in Europe with CE mark certification granted earlier this year. Blood is one of the most foundational gateways to health information. Even with the adoption of digital tools, today's solutions do not showcase all required regions of interest in a PBS slide, only capturing snapshots of cells. To help improve diagnostic accuracy leveraging novel computer vision tools, Full Field PBS gives clinical laboratories an unprecedented ability to capture digital scans using advanced computational photography imaging and tailored AI tools.

Aidoc announced today that the US Food and Drug Administration (FDA) has given regulatory clearance for the commercial use of its triaging and notification algorithms for flagging and communicating incidental pulmonary embolism . Flagging incidental, critical findings is a huge technical challenge due to the varied imaging protocols used and lower incidences of such cases. The ability to prioritize incidental critical conditions accurately is a breakthrough in the value AI can bring to the radiologist workflow. "The most common use case we experienced is for critical unsuspected findings in oncology surveillance patients" said Dr. Cindy Kallman, Chief, Section of CT at Cedars-Sinai Medical Center. "The ability to call the referring physician while the patient is still in the house is huge. We are essentially offering a point-of-care diagnosis of PE for our outpatients. Our referring physicians have been completely wowed by this."

Zebra Medical Vision, an Israeli medical imaging analytics company, said on Monday it received clearance from the U.S. Food and Drug Administration for its mammography technology. The company's latest cleared product uses artificial intelligence to prioritize and identify suspicious mammograms. The mammograms are automatically sent to Zebra's platform, where they are processed and analysed for suspected breast lesions. The HealthMammo product then returns its result to the radiologist. It is the company's first oncology tool to receive FDA clearance.

Mumbai-based startup Qure uses an AI imaging tool qER to save precious minutes for emergency room staff to take action based on head CT scans. After deployment in India and several other countries, qER is now entering the US where 75 million CT scans are performed every year. A couple of weeks ago, Qure received US FDA 510 (k) clearance for this product. What makes it special is a four-in-one clearance. The tool has been cleared for triaging four critical conditions--intracranial bleeds, mass effect (due to spaces in the brain filling up), midline shift (in the brain's alignment), and cranial fractures.

Nines, a Palo Alto-based teleradiology startup, received FDA 510(k) clearance for a system that can detect and triage two serious conditions from CT scans. The company's NinesAI system uses machine learning to identify potential cases of intercranial hemorrhage and mass effect, both of which are associated with strokes. The system then flags those cases for expedited review by radiologists. For both of these conditions, every hour counts toward a patient's survival. "This has been a long time coming. A lot of hard work went into it," CEO David Stavens said in a phone interview.

Aidoc, a Tel-Aviv, Israel-based medical imaging company, announced back in August that it had gained FDA clearance for a new solution that helps radiologists triage patients using artificial intelligence (AI). Now, to meet an increase in customer demand as a result of that announcement, the company has hired Tom Shearer to manage sales in North America and Jeremy De Sy to handle sales throughout Europe. "AI isn't the future for medical imaging; it's the present," Shearer said in a prepared statement. "Aidoc is led by extraordinary individuals who have developed a revolutionary product. This solution is always running in the background, on every exam, filling a critical need in medical imaging by helping radiologists manage their increasing workload while maintaining high standards."

Cognoa has gained regulatory recognition for its machine learning software as a class II diagnostic medical device for autism -- meaning the digital health startup is now positioned to submit an application for full FDA clearance. It's a first but important regulatory step for a business that was founded back in 2014, and plays in a still nascent digital health space where untested'wellness' apps are far more plentiful than medical technologies with robust data to prove out the efficacy of their interventions. Discussions with the FDA started in early 2017, says Cognoa CEO Brent Vaughan, adding that it's hoping to gain full FDA clearance this year. He says the ultimate goal for the US startup is to become a standard part of domestic health insurance-covered medical provision -- and for that FDA clearance is essential to opening the doors. We first covered the Cognoa at launch in 2014 and the following year when it was still being careful to describe its technology as a screening rather than a diagnostic system.

Kardia Band attaches to the Apple Watch like any other replaceable watch band. The user rests a finger on the sensor pad embedded in the band, allowing an EKG reading to be taken. The Kardia Band transmits its EKG reading to the Apple Watch (via a high-pitch audio signal) where it's displayed in real time as a moving waveform. When the 30-second EKG is finished, the user can view it on their phone or easily send the results as a PDF to their physician. Doctors can diagnose hundreds of diseases using EKG data, but AliveCor is cleared by the FDA only to record the EKG and to advise a user that the reading is normal, or possibly indicative of atrial fibrillation.