Soundwave Hearing announced it has received FDA 510(k) clearance for its Sontro Self-Fitting OTC Hearing Aids, which blend mobile technology and artificial intelligence calibration capabilities to self-fit and amplify sound for individuals aged 18 and older with mild to moderate perceived hearing impairment.
The Sontro hearing aids allow for personalization using AI technology to tailor the...
Digital health technology company NeuroRPM has received FDA 510(k) clearance for its AI-enabled remote monitoring app that utilizes an Apple Watch to track common Parkinson's symptoms such as bradykinesia, tremor and dyskinesia.
Bradykinesia is slowness of movement, and dyskinesia is involuntary or erratic movements.
The Washington D.C.-based company's algorithms are embedded in the Apple Watch...
Adherium, a New Zealand-based maker of connected respiratory medical devices, has received the US Food and Drug Administration's 510(k) clearance for connecting its digital monitoring platform with GlaxoSmithKline’s range of Ellipta dry powder inhalers.
The ASX-listed firm offers the Hailie sensor which attaches to an inhaler to remotely monitor and capture medication usage parameters and...
Smart imaging company Zebra Medical Vision landed an FDA 510(k) clearance for its cardiac-focused imaging tool called HealthCCSng.
The new tool is able to analyze non-gated CT scans and can quantify Coronary Artery Calcium (CAC). According to the company, the tool is able to categorize patients based on cardiac calcium detected and help clinicians detect patients with cardiovascular disease. ...
Israeli imaging startup Nanox has landed FDA clearance for its single-source digital X-ray Nanox.ARC, the company announced today. Nanox came on the imaging scene pitching to lower costs and sell its system via a price-per-scan model.
The company’s system combines an in-hospital scanning device with a companion cloud software tool. The X-ray device, which just landed the single-source clearance,...
Etiometry has received 510(k) clearance from the U.S. Food and Drug Administration to add enhancements to its clinical decision support platform for the intensive care environment.
Its platform offers end-to-end data management software solutions for the collection, analysis, visualization and archiving of ICU clinical data.
With its T3 Data Aggregation and Visualization software, clinicians get...
Fitbit’s new electrocardiogram app has officially received regulatory clearance in the U.S. and European Union for its latest smartwatch, the Fitbit Sense, to monitor heart rhythm and detect atrial fibrillation.
Now that the app has 510(k) clearance from the U.S. Food and Drug Administration and CE marking, Fitbit Sense users can access the ECG app beginning in October.
The company conducted a...
Tel Aviv, Israel-based Biobeat has been granted 510(k) clearance for a remote monitoring device capable of measuring the wearer’s blood pressure, oxygenation and heart rate.
Designed for use in the hospital or at home, the device is available as either a wristwatch or adhesive patch. Of particular note, the products differentiate themselves from other remote monitoring devices through a...
Kibbutz Shefayim, Israel-based deep learning startup Zebra Medical Vision announced yesterday that it has received an 510(k) clearance for an artificial intelligence tool that can read medical imaging to identify potential cases of pneumothorax — a build-up of gas between a lung and the chest wall.
The HealthPNX product scans a chest X-ray or digital radiography scan for signs of the condition,...
Looking to modernize the 510(k) process, yesterday the FDA announced its final guidance establishing the framework for the new Safety and Performance Based Pathway.
The biggest change to the 510(k) program is that instead of testing a new device in comparison to what is already on the market, new technology seeking clearance can be measured against a set of “objective, transparent and well...
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