Medtronic (NYSE:MDT) and the Medtronic Foundation announced a commitment of $3.8 million in support of COVID-19 relief. The $3.8 million donation is earmarked for providing healthcare workers support and protection, as well as including mental heatlh support, operational support and food assistance to communities and organizations in need, adding to a $10 million pledge made at […]
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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 […]
FDA allows dry heat treatment for single-user mask reuse
The FDA has announced that it will allow the use of dry heat to lower the bioburden on masks used by healthcare workers treating COVID-19 patients. While not authorizing equipment made by a particular company, guidance released last week said healthcare providers may use dry heat to reprocess NIOSH-approved filtering facepiece respirators, such as N95s, […]
BREAKING: Moderna is filing for a COVID-19 vaccine EUA
Moderna (NSDQ:MRNA) announced today that it will apply for emergency authorization from U.S. FDA and the European Medicines Agency for its COVID-19 vaccine candidate. The company said it has already initiated the rolling review process with the EMA, Health Canada, SwissMedic, the United Kingdom Medicines and Healthcare products Regulatory Agency, Ministry of Health in Israel, and […]
MedTech 100 roundup: Medtech stocks stagnant over holidays
Following the medtech industry’s rapid rise early in the month, a plateau was inevitable, and that trend continued through the holiday week. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week at 98.23 (Nov. 27), marking a 0.2% uptick from the 97.99 points registered at the […]
Analysts bullish on Medtronic after better-than-expected Q2
Analysts at UBS and Jefferies found a lot to like in the Street-beating Q2 results out of Medtronic (NYSE:MDT). “Commentary was encouraging on many fronts. COVID is raging, but hospitals are coping better this time, and MDT still expects to see normalized growth by 4Q. The bigger story is the new tone under CEO Geoff Martha. […]
Zimmer Biomet could pay millions after two hip implant lawsuit losses
A federal judge in Missouri has signed off on a $21 million judgment against Zimmer Biomet (NYSE:ZBH) involving the company’s much-litigated M2a Magnum metal-on-metal hip implant. U.S. District Judge Stephen R. Clark’s sign-off yesterday of the award — $20 million to Mary Bayes and $1 million to her husband Philip Bayes — came a day […]
U.S. plans to ship 6.4M COVID-19 vaccine doses to states in mid-December
About 6.4 million doses of the COVID-19 vaccine from Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) will ship to U.S. states in mid-December, as long as the vaccine soon receives an FDA EUA. There are also plans to quickly distribute vaccine from rival COVID-19 vaccine developer Moderna (NSDQ:MRNA), which could soon apply for an EUA, officials at the federal […]
FDA authorizes Kantaro’s ‘high performance’ COVID-19 antibody test
Kantaro Biosciences announced today that it received FDA emergency use authorization (EUA) for its COVID-SeroKlir antibody test. New York-based Kantaro, a joint venture between Mount Sinai Health System and RenalytixAI (NSDQ:RNLX), developed the semi-quantitative SARS-CoV-2 IgG antibody test kit to determine the presence and precise level of IgG antibodies related to COVID-19. A partnership with […]