The U.S. FDA’s two-day meeting of the patient engagement advisory committee (PEAC) covered a range of issues surrounding augmented reality (AR) and virtual reality (VR) products, but patient information and education was one of the key considerations. Naiem Nassiri of Yale Medicine cautioned, however, that a 15-minute briefing between doctor and patient during a face-to-face encounter would likely create more confusion than clarity, a conclusion that would suggest that other patient education methods will likely be needed.
Medtronic plc has entered a strategic collaboration with Cathworks Ltd. to expand the reach of Cathworks’ artificial intelligence (AI) guidance system for coronary artery disease management. Medtronic will invest up to $75 million and immediately begin co-promotion of the Ffrangio system on the U.S., European and Japanese market. As part of a separate agreement, Dublin-headquartered Medtronic will have the option to acquire Cathworks once certain undisclosed milestones are met.
Sonio SAS raised just over $5 million in its seed round to develop artificial intelligence (AI) software allowing health care professionals to determine the most appropriate pregnancy care. Its Sonio Diagnostic software delivers decision support for fetal ultrasound used in antenatal diagnostics.
The U.S. Federal Trade Commission (FTC) has been moving aggressively on privacy issues in connection with health data in the past two years, but the agency has issued an advisory of sorts to collectors of these data points. The FTC said July 11 that it intends to crack down on violators in an effort to protect data privacy.
Clinical analytics company Medial Earlysign Ltd. is expanding an existing partnership with Roche Holding AG to commercialize an artificial intelligence (AI) solution for the early detection of lung cancer. The companies originally signed an agreement in September to develop a personalized health solution for early detection of gastric cancer. The goal of the new collaboration is to develop Earlysign’s Lungflag software, which uses machine learning to identify patients at risk of developing lung cancer.
Kranus Health GmbH has raised $6.5 million in series A funding to ramp commercialization of its digital therapy for treating erectile dysfunction (ED). Eleven European investors participated in this fundraising. The round was led by early-stage health care venture capitalists Karista SAS, while Peak Pride Management GmbH also joined the funding round.
The Persona IQ combines a knee implant created by Zimmer Biomet Inc. with sensor technology developed by Canary Medical Inc. to capture performance data on range of motion, walking speed, step count and other orthopedic metrics. Liane Teplitsky, Zimmer Biomet’s president of global robotics likens the Persona IQ to a cardiac pacemaker, in this instance collecting important data on the knee implant so doctors working remotely can better understand how the device is performing post-surgery.
The U.S. CMS posted the draft Medicare physician fee schedule (MPFS) for calendar year 2023, and advocates of telehealth will be cheered by a proposed extension of some pandemic-driven telehealth services throughout 2023. The draft is less generous in connection with external electrocardiogram patches in a move that could ding Irhythm Technologies Inc., and its Zio XT device, but analysts at BTIG predict that any hit to reimbursement rates is likely to be offset with greater sales volumes, leaving Irhythm and its investors in a solid place going forward.
The U.S. FDA has given Resapp Health Ltd. the green light for its 510(k) Sleepcheckrx app to detect moderate to severe sleep apnea in adults as a prescription-only software-as-a-medical device. The FDA cleared the app as a class II medical device. Brisbane, Australia-based Resapp submitted the 510(k) premarket notification to the FDA in November 2021 for Sleepcheckrx for at-home sleep apnea screening.
Two Israeli companies aiming to improve in vitro fertilization (IVF) success rates received good news recently, with Aivf Ltd. hauling in $25 million in a series A round for Ema, its IVF software platform, and Fairtility Ltd. gaining CE mark for its CHLOE EQ embryo quality decision-support tool.
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