DeepX Diagnostics announced today that it received FDA clearance for its DermoSight digital dermatoscope. The DermoSight scope is used for teledermatology screening of suspect skin cancer lesions. Washington-based DeepX Diagnostics plans to enter the U.S. market having already completed more than 180,000 assessments in Europe. FDA clearance for DermoSight covers the acquisition of skin lesions […]
Diagnostics
Masimo wins FDA clearance for wearable vital sign monitor
Masimo (Nasdaq:MASI) announced today that the FDA cleared its Radius VSM patient-worn, continuous, multi-parameter vital signs monitor. Radius VSM enables physicians to monitor a range of physiological measurements. That includes Masimo SET pulse oximetry, noninvasive blood pressure, temperature, respiration rate and ECG. Masimo said its monitor combines the reliability and accuracy of larger bedside monitors […]
Perimeter Medical CEO resigns, board appoints replacement
Perimeter Medical Imaging AI today announced CEO Jeremy Sobotta has resigned, effective June 15, due to personal reasons. The Toronto-based company also announced its board of directors appointed Adrian Mendes at CEO, effective immediately. Sobotta will work closely with Mendes over the next few weeks to ensure a smooth transition of responsibilities. “We are grateful […]
Sparrow BioAcoustics wins FDA clearance for smartphone stethoscope
Sparrow BioAcoustics today announced it received FDA 510(k) clearance for its software that turns smartphones into medical stethoscopes. The downloadable Stethophone application uses advanced acoustic processing to provide clinicians with smartphones that have highly sensitive cardiac and pulmonary listening capabilities. It requires nothing to plug in, charge or connect, and heart and lung sounds are […]
Hologic CEO MacMillan to chair Illumina’s board
Illumina (NASDAQ: ILMN) announced today that its board has elected Hologic CEO Stephan MacMillan to fill a new seat and become its non-executive chair. Edwards Lifesciences CFO Scott Ullem will fill a second new seat — bringing the number of board seats to 11 at the San Diego–based DNA sequencing and array-based tech developer. The […]
CardioRenal receives FDA breakthrough designation for Tenor at-home blood potassium measuring device
CardioRenal today announced it received FDA breakthrough device designation for its Tenor at-home blood potassium measuring device. Tenor is a connected medical device that combines multiple technologies to assist patients with chronic illnesses, including chronic kidney disease, in measuring their blood potassium levels from the comfort of their homes. Patients can collect blood for testing […]
iRhythm has an FDA warning letter over Zio AT quality systems
iRhythm stock is down today on news of an FDA warning letter involving its Zio AT mobile cardiac telemetry device. In a Form 8-K filed with the SEC yesterday, iRhythm said it received the warning letter on May 25. The warning letter resulted from an FDA inspection at the company’s Cypress, California facility that concluded […]
A veteran Medtronic executive takes a new role at Baxter
Medtronic Cardiovascular Diagnostics and Services President Julie Brewer has left for a new position at Baxter. Brewer announced on LinkedIn near the end of last week that she has joined Baxter as President of the Patient Support Systems, Global Surgical Solutions and Care Communications team. “Baxter is a great company with a wonderful purpose of […]
HeartBeam partners with Samsung to boost at-home cardiac care
HeartBeam has announced a strategic alliance agreement (SAA) with global tech giant Samsung. The alliance, announced today, builds upon an existing SAA between Samsung and Livmor, whose assets HeartBeam acquired earlier this year. Livmor created the FDA-cleared wearable Halo atrial fibrillation detection system — an FDA-cleared, Samsung-Galaxy-watch-based arrhythmia detection tool. Meanwhile, HeartBeam recently secured a […]
The top cardiac care innovation news at Heart Rhythm 2023
The future of cardiac care was on display at the Heart Rhythm Society’s 2023 annual meeting. Medical device companies showcased groundbreaking technologies at Heart Rhythm 2023, May 19-21 in New Orleans. The innovations presented during the event offer new avenues for diagnosis, treatment, and monitoring of cardiovascular conditions, providing hope for patients worldwide. Boston Scientific, […]
HeartBeam wins AI-related patent for handheld vector ECG
HeartBeam (Nasaq:BEAT) announced today that it received a key patent relating to AI capabilities for its AIMIGo system. The U.S. Patent and Trademark Office (USPTO) issued the allowance for a patent titled “Hand Held Device for Automatic Cardiac Risk and Diagnostic Assessment.” The patent describes a system that combines recorded cardiac signals from AIMIGo with […]
