Connected home device maker Nest, which was bought by Google (NSDQ:GOOG) in 2014 for $3.2 billion, acquired smartphone-based health monitoring system developer Senosis Health last year in a hush-hush deal that may mark the business’ first steps towards an entry into the healthcare market, according to a GeekWire report. When the deal was initially reported last […]
Heidelberg Engineering wins FDA nod for upgraded eye imaging technology
The FDA has approved Heidelberg Engineering’s optical coherence tomography angiography module (OCTA), the company said today. The module is available for new and existing Spectralis upgradeable diagnostic imaging devices used to manage diabetic retinopathy, age-related macular degeneration and other macular diseases. OCTA is a noninvasive imaging technique that provides three-dimensional visualization of perfused ocular vasculature. Structural OCT uses […]
FDA hopes new disruptive wearables will lead to ‘universal digital future in healthcare’
The FDA is hopeful that devices like the new Apple (NSDQ:AAPL) Watch, which is designed to provide on-the-spot electrocardiogram tests and detect atrial fibrillation, will lead to a “reimagination of healthcare delivery,” according to a recent post from agency head Dr. Scott Gottlieb, but whether having that data will improve overall health has yet to be […]
Motus GI wins FDA nod for Pure-Vu slim colonoscopy sleeve
Motus GI said today that it won FDA 510(k) clearance for its Pure-Vu slim sleeve as part of its Pure-Vu system, intended for use during slim colonoscopies. With the clearance of the Pure-Vu slim sleeve, Motus GI said that the Pure-Vu system is now cleared for the full range of procedures in the colonoscopy market, with […]
Report: New Apple Watch features on-board EKG scanning, AF detection
Apple (NSDQ:AAPL) today unveiled its new Series 4 Apple Watch which the tech company said now features on-board electrocardiogram scanning technology, according to a report from The Verge. The Cupertino, Calif.-based tech giant said that it won FDA approval for the watch, and touted the EKG addition as the first EKG product to be offered over-the-counter […]
FDA clears Masimo’s Rainbow acoustic monitors for infants, neonates
Masimo (NSDQ:MASI) said today it won FDA clearance for its RAS-45 acoustic respiration sensor as part of its Rainbow Acoustic Monitoring system, cleared for use with infants and neonatal patients. With the clearance, the Rainbow Acoustic Monitoring system is now cleared for use with patients of all sizes, the Irvine, Calif.-based company said. Previously, the system […]
Body Vision raises $8.5 million to market cancer diagnostic system in U.S.
Body Vision Medical said today it has landed $8.5 million in funding to accelerate the commercialization of its LungVision lung navigation system in the U.S. and to extend its product line. The Ramat Ha Sharon, Israel-based company specializes in lung cancer diagnostics through augmented real-time intra-body navigation and imaging. Its catheter is designed for use […]
Check-Cap touts interim post-CE Mark C-Scan study results
Check-Cap (NSDQ:CHEK) today released interim results from the post-CE Mark approval study of its C-Scan system version 3, touting the device’s ability to detect polyps in un-prepped colons. The Israel-based company’s C-Scan system is designed as an alternative to standard colon cancer screening methods. The system uses an ingestible, ultra-low dose X-ray capsule and a wireless […]
BrainScope lands $4.5M to add vision assessment to its technology
The U.S. Department of Defense has awarded BrainScope a $4.5 million research contract to create and integrate ocular capabilities into its handheld, multi-parameter mild traumatic brain injury (mTBI) and concussion products. The Bethesda, Md.-based company’s initial product, BrainScope One, is the first FDA-cleared medical device that can assess the full spectrum of brain injury – from concussions (functional […]
Philips acquires pulse oximetry sensor maker Xhale Assurance
Royal Philips (NYSE:PHG) said this week it acquired pulse oximetry sensor maker Xhale Assurance for an undisclosed amount. Xhale Assurance produces a disposable pulse oximetry sensor designed to be placed on the wing of the nose to monitor heart rate and blood oxygenation under low perfusion conditions, which Amsterdam-based Philips said can be challenging with conventional […]
How AI can diagnose a leading cause of blindness
The study that led the FDA to approve an AI system for diagnosing diabetic retinopathy came out today, revealing how one of the leading causes of blindness can be detected in a primary care physician’s office. Published in the journal Nature Digital Medicine, the pivotal study of IDx-DR on 900 adults with diabetes showed 87% sensitivity, 90% specificity, and a 96% […]
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