Israeli startup NovaSight announced today that it has raised $8 million in a Series A round meant to support a large multi-center randomized pivotal study of its lazy eye treatment device. Study results will support potential FDA 510(k) clearance for the device. The money will also support development of future eye care products such as […]
Philips launches new face scanning tech, partners with BioIntelliSense on telehealth
Royal Philips (NYSE:PHG) today announced two separate steps toward helping patients receive remote care as telehealth’s importance continues to grow. Amsterdam-based Philips said today that it launched its Philips Respironics mask selector 3D facial scanning system for fitting masks and formed a strategic collaboration with BioIntelliSense to monitor at-risk patients from the hospital into the home. […]
Eko names Humbarger as new SVP
Eko announced yesterday that it appointed Bryan Humbarger as its new senior vice president of commercial with an emphasis on sales. The digital health sales veteran’s new role includes responsibilities for overseeing sales and commercial operations for Eko’s AI and telemedicine software platforms for health systems, practices and providers worldwide, according to a news release. […]
Dascena wins FDA beakthrough device designation for AI to predict kidney injury
Dascena announced today that it received FDA breakthrough device designation for its Previse algorithm for predicting acute kidney injury (AKI). The artificial intelligence (AI)-based algorithm is designed to predict AKI more than a full day before patients meet the clinical criteria for diagnosis. The company touts its regulatory victory as the first breakthrough nod for […]
Abbott wins FDA approval for Bluetooth heart rhythm devices
Abbott (NYSE:ABT) announced today that it received FDA clearance for its next-generation Gallant implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices. The next-generation devices offer a patient-preferred design with Bluetooth technology and a new patient smartphone app while sidestepping any compromise of battery longevity and MRI compatibility, according to a news release. Gallant, which […]
inHeart raises $4.2m
Cloud-based medical image analysis tech developer inHeart announced today that it closed a funding round worth $4.2 million (€3.7 million). Pessac, France-based inHeart, which provides image analysis for cardiac interventions on patients with arrhythmias, said in a news release that the funding round, led by Elaia, will be used to accelerate commercial development in Europe, […]
B,. Braun, Baxter, CareStream, Green Hills affected by Ripple20 cyber vulnerabilities
The U.S. Cybersecurity and Infrastructure Security Agency (CISA) said it is aware of vulnerabilities affecting Treck IP stack implications for embedded systems. Known as Ripple20, the vulnerabilities allow a remote attacker to exploit and take control of an affected system, according to the CISA statement. Among the affected companies were B. Braun, Baxter (NYSE:BAX), Green Hills […]
Partnership will study use of existing drugs for COVID-19 and and more
A new collaboration funded by in part by $1.1 million from the FDA is working on finding new uses for existing drugs for areas of high unmet medical need — with a pilot project focused on treatments for COVID-19. The Critical Path Institute (C-Path) this week announced the launch of the CURE Drug Repurposing Collaboratory […]
FDA clears Masimo respiration sensor
Masimo (NSDQ:MASI) announced today that its Centroid wireless orientation, activity and respiration rate sensor received FDA clearance. Centroid is a wearable sensor designed to monitor patient position in an effort to avoid preventable pressure ulcers, while also alerting clinicians to sudden movements, such as fall-like events. The device also detects chest movements to continuously provide respiration […]
Perimeter Medical Imaging to go public in Toronto
Perimeter Medical Imaging — creator of AI-based medical imaging tools for cancer surgery — plans to go public on the TSX Venture Exchange in Toronto on the week of June 29. The Toronto- and Dallas-based company is going public at the same time that it enters the commercial stage for its proprietary, FDA-cleared OCT imaging […]
Tandem Diabetes Care acquires Sugarmate mobile app
Tandem Diabetes Care (NSDQ:TNDM) said today that it has purchased Sugarmate — as mobile app that helps people better manage their diabetes. Financial terms of the deal were not disclosed. Nearly 30,000 people relying on insulin pumps or multiple daily injections presently use the Sugarmate app. Get the full story on our sister site Drug Delivery […]
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