Stryker Corp. has launched its Surpass Evolve flow diverter following an earlier U.S. FDA approval. According to the company, it is the first 64-wire cobalt chromium flow diverter in the U.S. designed to redirect blood flow and promote aneurysm healing. Ajay Wakhloo, the first physician to complete a commercial case in the U.S., noted that the offering builds on Stryker’s Surpass Streamline. “By increasing the braid angle, the novel 64-wire device delivers excellent flow diversion and a highly flexible implant for enhanced vessel wall contact. The higher mesh density of Surpass Evolve vs. traditional 48-wire flow diverters may lead to faster aneurysm occlusion for patients," Wakhloo said. Read More
Informed Data Systems Inc. (IDS), doing business as One Drop, scooped up $98.7 million in new financing and commitments to accelerate the expansion of its digital health platform beyond diabetes. The company raised $34.7 million in a series C round led by Bayer AG, of Leverkusen, Germany. Bayer also committed $64 million in development fees and commercial milestones related to a 2019 licensing agreement to leverage the One Drop solution across multiple therapeutic areas. Read More
The U.S. Administrative Procedures Act (APA) has proven controversial for device makers in that the associated requirements for rulemaking have been the subject of regulatory end-runs, by some accounts. The Department of Justice (DOJ) said in an Aug. 11 statement, however, that it is time to update the APA because the it has ossified in the 74 years since passage, while an attached report estimated that government regulation adds as much as $2 trillion in compliance costs to the economy every year. Read More
As of Aug. 13, more than 90,000 patients hospitalized in the U.S. with COVID-19 already had been given access to convalescent plasma through a national expanded use protocol (EAP) sponsored by the Mayo Clinic. The FDA’s decision Sunday to grant emergency use authorization (EUA) for the potential therapy will further expand access to convalescent plasma for hospitalized patients throughout the country at a time when fully approved COVID-19 treatments are nonexistent and even EUAs are few and far between. Read More
Through the use of sequencing data, researchers in Hong Kong presented a case study providing the strongest evidence yet that individuals can become reinfected with SARS-CoV-2 after clearing a first infection. Read More
LONDON – Biofidelity Ltd. has raised US$12 million in a series A, enabling it to start commercialization of a novel, low-cost, chemistry-based diagnostic for detecting all actionable lung cancer mutations. The Cambridge, U.K.-based company claims the test can detect a single molecule of mutated DNA against the background of billions of healthy molecules in a patient sample, without the need for DNA sequencing. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brainsway, Guardant Health, Helixbind. Read More
Keeping you up to date on recent developments in cardiology, including: Deep chest compressions help save brain; Selfies for heart disease?; Looking to the past to understand the heart. Read More
