The latest 510(k) clearance for the Verily Study Watch will further the efforts of the Google sister company and iRhythm Technologies (NSDQ:IRTC) to improve atrial fibrillation treatment. Verily — a life science company under Alphabet (NSDQ:GOOGL) — recently received an FDA 510(k) clearance to include an irregular pulse monitor in its Study Watch wearable. “We’ve worked carefully […]
Edwards Lifesciences stock takes a hit on TAVR report
Edwards Lifesciences (NYSE:EW) shares are recovering a bit today — a day after the stock took a nearly 5% slide after a Jefferies report suggested a potential step down in TAVR sales in December. The Jefferies model showed a sharp step down in December growth (–2% to +3%) from October and November (+27–28%). The result was […]
FDA grants Medtronic an IDE to study new tech for ablating heart tissue
Medtronic (NYSE:MDT) announced today that it won FDA approval to move forward with an investigational device exemption trial to evaluate the safety and effectiveness of its PulseSelect pulsed-field ablation (PFA) system. The PulseSelect system is designed to use the pulsed electric fields to treat atrial fibrillation (Afib). It uses the fields to ablate or create lesions […]
BioVentrix granted CE Mark extension for Revivent TC system
BioVentrix announced today that it received an extension of its CE Mark for the Revivent TC transcatheter ventricular enhancement system for heart failure. The extension of the initial CE Mark approval BioVentrix won in 2016 allows the device to be marketed throughout European Union member nations until May 2024, according to a news release. BioVentrix’s […]
Major Texas health system will use CHF Solutions’ Aquadex FlexFlow system
CHF Solutions (NSDQ:CHFS) announced today that Texas-based Baylor Scott & White Health began offering aquapheresis therapy using its Aquadex FlexFlow system. Temple, Texas-based Baylor Scott & White Health is a major not-for-profit healthcare system in the state and among the largest in the U.S. The health system is now set to offer the Aquadex Flexflow at […]
Teleflex wins FDA clearance for Wattson temporary pacing guidewire
Teleflex (NYSE:TFX) announced today that it won FDA 510(k) clearance for its Wattson temporary pacing guidewire for use during transcatheter aortic valve replacement (TAVR) and balloon aortic valvuloplasty (BAV). The Wattson guidewire is designed to simplify and shorten procedures by eliminating the need for the routine use of central venous access and transvenous temporary pacing […]
Abbott Q4 sales beat The Street
Abbott (NYSE:ABT) shares are up this morning on reported fourth-quarter 2019 earnings that met Wall Street analysts’ expectations, with sales beating The Street. The Abbott Park, Ill. company posted profits of $1.705 billion or $0.95 per share, on sales of $8.31 billion for the three months ended Dec. 31, 2019, for a bottom-line gain of […]
CardioFocus names new CEO
CardioFocus announced today that its board of directors promoted chief operating officer Burke Barrett as its new CEO, effective Jan. 19, 2020. The 30-year veteran joined CardioFocus in 2002 and held roles ranging from vice president though president and COO, according to a news release. Before CardioFocus, Barrett served as VP of clinical operations at […]
Robocath performs first robotic coronary angioplasties in Germany
Robocath announced today that it completed the first robotic coronary angioplasties with its R-One robotic catheter guidance system in Germany. Professor Michael Haude, director of Medical Clinic I at Rheinland Klinikum Neuss Lukaskrankenhaus, and his team, performed the percutaneous coronary interventions with the R-One system. Rouen, France-based Robocath CEO Lucien Goffart believes the procedures in […]
BREAKING: Medtronic wins FDA approval for Micra AV
Medtronic (NYSE:MDT) has won FDA approval for its Micra AV — greatly expanding the number of people who could potentially benefit from leadless pacemaker technology. The medical device giant plans to start offering the Micra AV in a limited number of implanting centers in the coming weeks, with a full launch expected in the spring. FDA […]
Abbott wins MitraClip patent spat with Edwards — for now
The U.S. Patent Trial and Review Board (PTAB) this week shot down an attempt by Edwards Lifesciences (NYSE:EW) to invalidate the patents that Abbott (NYSE:ABT) holds on its MitraClip transcatheter mitral valve repair (TMVR) device. In a ruling published Thursday, the PTAB said Edwards failed to show that it would prevail in with at least one […]
- 1
- 2
- 3
- …
- 273
- Next Page »
MassDevice Network
@MassDevice
LinkedIn
YouTube