Teleflex Inc. reeled in $628.3 million in revenue in the third quarter, down 3.1% from the same period last year but ahead of the Street’s 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 Teleflex’s reveal of a definitive agreement to acquire hemostatic products company Z-Medica LLC for up to $525 million. Read More
The PMA for the Neovasc Reducer device for treatment of drug-refractory angina faltered at an Oct. 27 U.S. 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.” Read More
If a new federal rule withstands politics and potential court challenges, U.S. health care prices may finally be freed from their historic black box. The Centers for Medicare & Medicaid Services, along with the Departments of Labor and the Treasury, issued the Transparency in Coverage final rule Oct. 29 requiring most private health plans to disclose pricing and cost-sharing information so Americans will know in advance how much they will have to pay for prescription drugs, medical devices and other health care products and services. Read More
TORONTO – Whether it’s President Trump obtaining the drug Regeneron or COVID-19 test kits fast tracked in the U.S. and Canada, this has been the year of temporary emergency approvals for drugs and medical devices. What is sometimes overlooked are permanent programs like Canada’s Special Access Program and the U.S.’s Expanded Access Program, designed to provide therapeutics to patients who have exhausted every avenue for a cure or relief from a devastating disease. Read More
Tencent Holdings Ltd. has launched two med-tech solutions to facilitate data sharing and management with artificial intelligence capabilities, marking an additional step into the smart health care realm for the company. The Chinese tech giant unveiled the two products at the 83rd China International Medical Device Expo Oct. 20. Read More
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. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: ONC delays health IT compliance dates due to COVID-19; DOJ drops $8.1 million fine on Medtronic over FCA violation; CMS posts DME draft rule; NIH lays out final policy on data sharing; NICE posts two health technology assessments. Read More
Med-tech firms raising money in public or private financings, including: Advanced Chemotherapy Technologies, Baxter International, Relievant Medsystems. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chf Solutions, Dia Imaging Analysis, Illuminoss Medical, Medtronic. Read More
Keeping you up to date on recent developments in diagnostics, including: A case for pooled testing of SARS-CoV-2; FIT as effective as colonoscopy in ruling out suspected colorectal cancer; Looking to comparative genomics analysis to explain COVID-19 susceptibility. Read More
