Teleflex Inc. reeled in $628.3 million in revenue in the third quarter of 2020, down 3.1% from the same period last year but ahead of the Street estimate of $619.4 million. Earnings per share also beat consensus, at $2.46 vs. $2.24. The release of the quarterly results dovetailed with the Teleflex reveal of a definitive agreement to acquire hemostatic products company Z-Medica LLC for up to $525 million.
Even CRF’s Gregg Stone couldn’t save Neovasc Reducer at FDA advisory
The PMA for the Neovasc Reducer device for the treatment of drug-refractory angina faltered at an Oct. 27 FDA advisory committee, but it wasn’t for lack of support from star-power cardiologists. Gregg Stone, of the Cardiovascular Research Foundation, gave an impassioned plea for approval, pointing out that these patients have few options if they are poor candidates for bypass grafting or percutaneous coronary intervention. Stone said, “this is really a desperate patient cohort,” adding that a two-class improvement in angina severity “is a robust reduction.” Nonetheless, the panel gave the device failing marks for effectiveness, leaving Neovasc facing the prospect of enrolling a randomized, controlled trial that Stone said may take as many as five years to complete.
SAP draws mixed reviews from Canadian doctors heading medical device companies
TORONTO – Medical device experts and physicians heading med-tech companies have mixed views of Canada’s Special Access Program (SAP) designed to provide unapproved therapeutics to patients who have exhausted every avenue for a cure or relief from a devastating illness. While most see value in the program, one complaint is a lack of clarity on what technical information a doctor must provide to make a special access request for a patient. A broader worry is the risk posed by SAPs drawing patients anxious for an immediate cure away from participation in clinical trials and the loss of valuable data this might entail. The U.S. offers similar emergency relief for patients in exigent circumstances through its Expanded Access Program.
Tencent launches AIMIS medical image cloud to enhance medical imaging management
Tencent Holdings Ltd. has launched two med-tech solutions to facilitate data sharing and management with artificial intelligence capabilities, marking a step further into the smart health care realm for the tech giant.
ASHG 2020: New inflammatory disease, and maybe, a new classification system
Anthony Wynshaw-Boris, professor and chair of the department of genetics and genome sciences at Case Western Reserve University School of Medicine, set a positive tone in his opening talk at the 2020 annual meeting of the American Society of Human Genetics (ASHG). "This is guaranteed to be the best-ever virtual ASHG annual meeting," he told the audience. The opening plenary abstract session, for one, did not disappoint. It began with the definition of a new disease, identified through a new approach, and possibly leading to a new way to think about rheumatic diseases.
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Ai Biomed, Ambra Health, Axonics, Baxter International, Biocartis Group, Boston Scientific, Breathonix, CHF Solutions, Daxor, Dia, D-Mark Biosciences, Epic Sciences, Exact Sciences, Inflammatix, Jack Nathan Health, Lantheus, Lifedojo, Medtronic, Nanox, Novocure, Nucleix, Ontrak, Pdi, Predicine, Rb Medical Supply, Relievant Medsystems, S2 Genomics, Sengenics, Simplify Medical