The Centers for Medicare & Medicaid Services (CMS) finalized policies that increase access to artificial hearts and ventricular assist devices (VADs). In August, CMS proposed the coverage policy updates meant to increase access to VADs and artificial hearts, which represented potentially good news for major VAD makers Abbott (NYSE:ABT) and Medtronic (NYSE:MDT) and for people with heart failure who […]
Cardiovascular
UK regulators recommend iRhythm cardiac arrythmia device
iRhythm Technologies (NSDQ:IRTC) announced that it received a recommendation for adoption from National Institute for Health and Care Excellence (NICE). San Francisco-based iRhythm said in a news release that it is the first technology to pass through a new digital health tech pilot, resulting in the successful recommendation for adoption from NICE. The company’s Zio XT […]
Zimmer Biomet completes A&E Medical acquisition
Zimmer Biomet today said it completed the acquisition of A&E Medical for $150 million in cash at closing and $100 million in cash payable in 2021. Through the deal, Zimmer Biomet is acquiring the company and its complete portfolio of sternal closure devices, including sternal sutures, cable systems and rigid fixation and a range of […]
Boston Scientific CEO Mike Mahoney talks Lotus decision, post-COVID outlook
Boston Scientific (NYSE:BSX) made waves this month when it recalled and retired its Lotus TAVR product line. Subsequent layoffs, first in Minnesota, then in Ireland, highlighted the impact of the decision to pull Lotus from the highly competitive market as a result of complexities related to the product delivery system and solely that — as the […]
Next-gen MitraClip performs as well as earlier version
The award-winning next-generation MitraClip from Abbott (NYSE:ABT) reportedly performs as well as the previous version of the heart valve technology. According to reports in TCTMD, analysis presented by Abbott last week from its EXPAND registry compares favorably with outcomes seen in the landmark COAPT trial back in 2018. EXPAND was conducted across 57 locations in the […]
Vectorious’ in-heart microcomputer wins FDA breakthrough nod
Vectorious Medical Technologies today announced that the FDA has granted breakthrough device designation for the company’s left atrial pressure (LAP) monitoring device. The V-LAP system is the first digital, wireless, battery-free device that can communicate from deep within the body using high-resolution waveform morphology, according to the Tel Aviv-based startup. Because the pressure of the […]
Canon Medical launches one-beat spectral cardiac CT
Canon Medical (NYSE:CAJ) announced today that it launched one-beat spectral cardiac CT capabilities on the Aquilion One/Prism Edition. Tustin, Calif.-based Canon Medical’s deep-learning spectral CT for cardiovascular imaging offers the one-beat spectral CT capabilities, thanks to a 16 cm-wide area detector which allows for one rotation to image the entire heart in as little as 0.275 […]
Alivecor wins FDA clearance for next-gen interpretive ECG algorithms
AI-based electrocardiogram (ECG) technology developer AliveCor announced that it received FDA clearance for its next-gen ECG algorithms. Mountain View, Calif.-based AliveCor’s next-gen interpretive ECG algorithms, called Kardia AI V2, offers users a way to take a 30-second ECG and receive instant determinations of multiple cardiac conditions through the company’s KardiaMobile and KardiaMobile 6L devices and the […]
Chong Kun Dang to sell SkyLabs heart-monitoring ring in Korea
Pharmaceutical company Chong Kun Dang next month will start selling a heart-monitoring ring made by startup SkyLabs, according to Korean media reports. Chong Kun Dang paid ₩2.5 billion ($2.2 million) to SkyLabs for the right to sell the CART-I cardio tracker to consumers in South Korea, The Korea Herald reported today. Worn on a finger, […]
Boston Scientific’s Lotus layoffs extend to Ireland
Boston Scientific (NYSE:BSX) has reportedly confirmed job losses at its Galway, Ireland, location, following the retirement of the Lotus Edge. Galway Bay FM reported today that the Marlborough, Mass.-based company confirmed the job losses at its Ireland location, adding that Boston Scientific confirmed the job loss will affect fewer than 30 employees. The report said that […]
Boston Scientific to lay off 106 following Lotus Edge heart valve retirement
Boston Scientific (NYSE:BSX) is set to lay off 106 employees in Minnesota following the retirement of its Lotus Edge device, according to reports. Bring Me the News reported that the company is permanently laying off the 106 workers at its Maple Grove, Minn. location, having notified the state of Minnesota via a WARN letter, as is […]