Pq Bypass Inc. received breakthrough device designation from the FDA for its Detour system, the first to permit fully percutaneous femoropopliteal bypass to treat extremely long, complex blockages in the superficial femoral artery (SFA). “This designation is a major milestone for Pq Bypass, and we expect this technology to change the paradigm for complex SFA treatment in the way EVAR and TAVR changed the paradigm for aortic repair,” said Rich Ferrari, chairman and CEO of Pq Bypass. Read More
The U.S. Centers for Medicare and Medicaid Services (CMS) finalized its Medicare inpatient payment rule for fiscal 2021, and Boston Scientific Corp., of Marlborough, Mass., was perhaps a surprise winner with a new technology add-on payment (NTAP) for its Eluvia paclitaxel-coated stent for the lower limbs. The Eluvia had faltered at a previous NTAP application due to the controversy over paclitaxel in devices for the peripheral vasculature, but Boston Scientific said in a Sept. 3 press release that the decision to grant an NTAP payment “is particularly important,” given the scrutiny applied to paclitaxel’s use in these devices. Read More
Biofourmis Inc. scooped up $100 million in a series C round that was led by Softbank Vision Fund 2. The funds are earmarked to accelerate U.S. and global expansion of Biofourmis’ artificial intelligence (AI)-powered health analytics platform and to advance its pipeline of digital therapeutics. The company focuses software-based therapeutics and AI tools for personal predictive care and has U.S. FDA-cleared products that aim to boost clinicians’ ability to remotely monitor and treat patients. Read More
Detectachem Inc. has scored an emergency use authorization (EUA) from the U.S. FDA to market a new molecular RNA test kit for SARS-CoV-2 that provides color-coded results in about 30 minutes. Read More
While the emergency use authorization (EUA) the FDA granted Aug. 23 for convalescent plasma remains a political talking point, the agency moved ahead Sept. 2, issuing an updated, immediately effective guidance on the use of convalescent plasma to treat COVID-19 patients in ongoing clinical trials, on an expanded access basis or under the EUA. Read More
An Australian study led by University of Melbourne scientists has identified a previously unknown role for the hepatokine, sparc-related modular calcium-binding protein 1 (SMOC1), in suppressing hepatic glucose production. The investigators reported their results in the Sept. 2, 2020, edition of Science Translational Medicine. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Avanos Medical, Cicero Diagnostics, Exactech, Gala Therapeutics, Inspiremd, Smith+Nephew. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Syntheticmr. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Axonics Modulation Technologies. Read More
Keeping you up to date on recent developments in diagnostics, including: A simple point-of-care COVID-19 test; A deep-learning method to predict AMD risk; AP-1 and antidepressant action; Orasure collection device included in Miradx EUA. Read More
