BioSig Technologies (OTCQB: BSGM) said today it won FDA 510(k) clearance for its Pure EP electrophysiology system. The Santa Monica, Calif.-based company said the PureEP system is designed for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology procedures. The newly cleared system is intended to reduce […]
Avinger posts loss on disappointing sales
Avinger (NSDQ:AVGR) today posted a second-quarter losses-per-share that missed an analyst’s expectation, sending its share price down on Wall Street despite nearly halving its losses. The Redwood City, Calif.-based medical device maker reported losses of -$6.6 million, or -98¢ per share, on sales of $2.1 million for the three months ended June 30, 2018. That compares with […]
“Snake oil” BP app got high user marks despite inaccurate results
People may like mobile blood pressure apps better when the apps reveal positive results, even if those results are inaccurate 80% of the time, according to a recent study. A team of researchers who previously revealed the inaccuracy of the Instant Blood Pressure (IBP) app returned to the topic to study 81 adults who compared the app’s readings […]
Report: New hack could put malware directly on Medtronic pacers, allow full control
Vulnerabilities within with Medtronic‘s (NYSE:MDT) pacemakers, its Carelink 2090 pacemaker programmer and associated infrastructure could allow an outside agent to plant malware on the pacers that would allow them to control all shocks delivered by the device, according to a new Wired report. The vulnerabilities were discovered by security firm Whitescope’s Billy Rios and QED […]
Medtronic launches Extravascular ICD pilot study
Medtronic (NYSE:MDT) said yesterday it launched a pilot study of its investigational Extravascular Implantable cardioverter defibrillator system, with the first patient implant already performed at New Zealand’s Christchurch Hospital. The Fridley, Minn.-based company’s EV ICD system uses leads placed outside of the heart and veins to provide both defibrillation and antitachycardia pacing therapy. The initial implantation […]
CryoLife shares up on street-beating Q2 revenues
CryoLife (NYSE: CRY) beat analysts’ revenue estimate by 11% in the quarter ended June 30, driving shares up $3.75 in mid-afternoon trading. Atlanta, Ga.-based CryoLife’s revenue hit $68.5 million in the quarter, up from $47.8 million for the same period of 2017. Its bottom line slumped to $226,000 or 0.1¢ per share, well below Wall Street’s projection of 0.8¢ […]
Spectralytics invites customers to ‘camp out’ at new development center
Spectralytics has completed a dedicated product development center in Maple Plain, Minn. to speed delivery of prototypes to customers and free up the production lines in its other facilities. Spectralytics’ two existing plants in Dassel, Minn., 55 miles west of the Twin Cities, offer laser cutting, welding, drilling, ablation, marking, electropolishing, assembly, and engineering services […]
Neovasc touts Reducer study data
Neovasc (NSDQ:NVCN) today touted results from a study of its Reducer device designed for treating refractory angina. The Reducer system is designed to alter blood flow in the heart’s circulatory system to increase perfusion of oxygenated blood to ischemic areas of heart muscle, and can be placed in a minimally invasive transvenous procedure, the Vancouver-based company said. […]
LivaNova touts completion of 1st-in-man transseptal Caisson TMVR feasibility study
LivaNova (NSDQ:LIVN) said today it concluded the Prelude first-in-human feasibility study exploring the transseptal use of its Caisson transcatheter mitral valve replacement system designed to treat mitral valve regurgitation. In the study, investigators explored the use of the Caisson TMVR system through a transseptal approach, which the London-based company claims is a less-invasive approach which uses […]
NextGen Medical targets clots in large vessels
NexGen Medical Systems announced the successful completion of the first human use of its XCOIL large vessel (18mm) thrombectomy system for the treatment of deep vein thrombosis (DVT). The new device represents an expansion of the company’s 12mm XCOIL system and is designed to rapidly remove blood clots in large vessels, such as the iliac vein. […]
JenaValve launches feasibility study of next-gen pericardial TAVR system
JenaValve Technology said today it launched an FDA investigational device exemption cleared early feasibility study of its next generation JenaValve pericardial transcatheter aortic valve replacement system. The newly launched trial will explore the use of the device as a minimally invasive treatment for patients with symptomatic, severe aortic stenosis and symptomatic aortic regurgitation in patients who […]
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