KARACHI, Pakistan – Faced with lockdowns and massive disruptions to supply chains, distributors and manufacturers of surgical equipment in countries across South Asia like Pakistan, Indian, Bangladesh and Nepal are struggling to find a way forward but also looking for opportunities to expand their share of the global market while reducing their existing reliance on imports of basic supplies.
The U.S. FDA’s effort to compile a guidance for prescription, point-of-care (POC) blood glucose meter (BGM) test systems seems to show that guidances can be as iterative as the devices they govern. The FDA announcement for the Sept. 28, 2020, final guidance said that the differences between the 2020 final and the 2018 draft include “a minor edit” regarding user accessibility and a technical correction for hemoglobin testing concentration, yielding a document that is finally ready for prime time after four tries over six years.
Abbott Laboratories is celebrating another win with its continuous glucose monitoring (CGM) technology. This time, the company revealed that it has scored the CE mark for its next-generation Freestyle Libre 3 system. Wells Fargo’s Larry Biegelsen noted that the arrival of the CE mark came slightly earlier than his group had expected.
Boston Scientific Corp. reported the controlled launch of its Acurate Neo2 aortic valve system in Europe. The next-generation transcatheter aortic valve implantation (TAVI) technology extends the clinical performance of the original Acurate Neo platform and includes an expanded indication for patients with aortic stenosis.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hologic, Masimo, Quotient, Zymo Research.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Angle, Endpoint Health, Fibrogenesis, Handsfree Health, Ibiologics, Stryker.