mhealth’s SnapECG is a medical-grade handheld single-lead electrocardiograph that connects via Bluetooth to a smartphone. It gives a recording of the heart’s electrical pulses, and stores the data to be given to a doctor later. It has received CE mark in Europe and approval from the Chinese Food and Drug Administration (CFDA). It can be (Read more...)
Tag: Cardiology
TSP Crosser for Transseptal Puncture and Left Atrial Navigation Cleared by FDA
Transseptal Solutions, a firm based in Israel, has been given clearance to introduce its flagship TSP Crosser Transseptal Access System in the U.S. The device is used to provide a path and to deliver catheters into the left atrium of the heart. Most minimally invasive cardiology procedures have been performed on the right side of […]
Pervasive ECG: Integrating Body Sensors Into Everyday Things (Interview)
Wearable devices with body sensors have been seen by many as a way to get the general public to be better aware of their overall health. It’s a nice idea, but it still requires people to remember to wear their devices, to check up on the readings via the smartphone, and to recharge the devices […]
Tiny New Endoscope for Looking Inside Blood Vessels
Cambridge Consultants, a UK firm, and OmniVision, based in California, have developed an impressive intravascular camera. It produces native images at 400 x 400 pixel resolution, considerably better than existing fiber-optic angioscopes, but engineers at Cambridge Consultants believe this can be boosted to 1,600 x 1,600 with its own software techni (Read more...)
B-Laser, The First 355nm Laser for Peripheral Artery Disease Cleared by FDA
Eximo Medical, based in Israel, won FDA clearance for its B-Laser Atherectomy System that’s used to clear out plaque from within narrowed peripheral arteries, including in cases of in-stent restenosis. The laser operates at a 355nm wavelength, the only one of this kind, and the company believes that this wavelength has benefits over the commo (Read more...)
FDA Clears First App-Only Product for Detecting Atrial Fibrillation
FibriCheck, a Belgian firm, won FDA clearance for its smartphone application that is capable of spotting signs of atrial fibrillation, simply by using the phone’s camera. The user places a finger over the camera lens on the back of the phone and initiates the app to do its thing. The app utilizes photoplethysmography to optically watch [ (Read more...)
PureFlow External Counter-Pulsation Therapy System Cleared by FDA
Xtreem Pulse, a company based in New York City, was cleared by the FDA to introduce its PureFlow system in the U.S. as a treatment option for patients with chronic stable angina that is refractory to optimal anti-anginal medical therapy while not being able to receive a revascularization procedure. The company says the device is […]
SleepScore Lab’s Non-Contact, No Hardware Sleep Monitoring System: Product Review and Interview with CEO
It has been less than a year since Medgadget tried out SleepScore Lab’s SleepScore Max, the company’s second generation of sleep monitoring devices, following the S+ system. Today, we’re onto their third offering: the SleepScore App. While both S+ and SleepScore Max systems paired hardware and software in a combined offering, the (Read more...)
Science Fiction Inspired Handheld Diagnostic Device
A team of researchers at Glasgow University, UK have developed a portable rapid diagnostic device that could be used to detect a number of conditions, including cancer and cardiovascular disease. Inspired by the famous Star Trek medical tricorder, the research team behind the innovation set out to create a “multicorder” device. The (Read more...)
Interview with Tobias Pforr of aktiia, an Optical Blood Pressure Monitoring Company
aktiia, a Swiss company that promises to deliver an optical blood pressure monitoring device, just raised $4 million USD in seed funding. We spoke with aktiia’s Tobias Pforr, head of business development and marketing, and Josep Sola, CTO, to learn more. Ben Ouyang, Medgadget: Tell me about aktiia. Tobias Pforr, aktiia: aktiia was (Read more...)
EverSleep Wearable Sleep Tracker: Product Review and Interview with CEO
Readers might recall the 2017 Indiegogo campaign by SomnoHealth to create EverSleep, a wearable sleep tracker with built-in oxygenation monitoring. The campaign reached 224% of its original goal in addition to receiving a $50k Arrow Electronics Flash Funding Grant and recognition as a 2017 National Sleep Foundation SleepTech 2017 Semifinalist. Toda (Read more...)
First Blood Pressure Monitor with Cellular Connectivity Now Available in U.S.
Livongo, a Silicon Valley firm, is releasing in the U.S. its cellular-based blood pressure monitor, along with a smartphone app and accompanying online platform for managing and sharing the readings. The blood pressure unit uploads its measurements to the Livongo cloud platform, without having to connect the device to a WiFi network, what the compa (Read more...)
ZEEQ, World’s “Smartest Pillow”: A Medgadget Review
We spend around one-third of our life sleeping, and as we all know, the quality of our sleep directly affects how we feel and function the following day. Those of us looking for a better night’s sleep often start by searching for a “better” pillow, but what does that mean? We have all heard companies […]
BIOTRONIK PK Papyrus Stent for Emergency Repair of Coronary Perforations
BIOTRONIK obtained FDA’s approval, under the Humanitarian Device Exemption, for its PK Papyrus covered coronary stent system. It’s indicated for emergency use when treating acute coronary perforations, both of native vessels and bypass grafts, and is the only device of its kind available to treat vessels between 2.5 mm and 5.0 mill (Read more...)
Flexible Stick-On Ultrasound Patch Measures Central Blood Pressure
Scientists at the University of California San Diego created a flexible ultrasonic patch that can measure the blood pressure in major vessels such as the jugular vein and carotid artery. The technology has already shown, in a proof-of-concept study, that it may be made as accurate as invasive means to measure the central blood pressure. […]
ResMed Unveils “Minimal-Contact” Full Face CPAP Mask
ResMed is releasing a new full face CPAP mask that the company claims to be its first “minimal-contact” device of this kind. The AirFit F30 mask features a cushion that avoids sitting on top of the nose, preventing rubbing of that area and disturbing the visual field of view, something that can lead to claustrophobia […]
Apple Unveils New Watch with ECG Built-In
Apple just unveiled its latest smartwatch, the Apple Watch Series 4, and it has one impressive new medical feature: a built-in single-lead ECG (electrocardiograph). The FDA has cleared it as a medical device, according to Apple, and we assume the clearance is for detecting certain cardiac arrhythmias, particularly atrial fibrillation. Previously, t (Read more...)
Boston Sci’s ACURATE neo2 Aortic Valve Showing High Performance
Boston Scientific is touting results of a clinical study evaluating its ACURATE neo2 prosthetic aortic valve system. The implant and delivery system, which are not yet available for sale, had “a high procedural success rate and a low rate of paravalvular aortic regurgitation,” which is blood leaking around the valve, a month after (Read more...)
Nuubo for Comfortable All Day ECG Arrhythmia Monitoring
Nuubo, a company based in Madrid, Spain, won FDA clearance for its Nuubo System to be used within the hospital for diagnosing arrhythmias. Unlike multi-day, multi-lead ECG monitoring often found within clinics today, the Nuubo doesn’t rely on a bunch of loose wires running under the clothing to a box on the belt. The Nuubo […]
Stanford Researchers Print Patient Specific Heart Mapping Sensors
Interventional cardiologists dealing with atrial fibrillation, the most common arrhythmia, tend to seek out and ablate the tissue generating aberrant electrical signals. This is done with mapping catheters, the shape of which is designed to maximize contact with the heart to best gather the heart’s intrinsic electrical signals. Each patient i (Read more...)