As the COVID-19 pandemic continues into the fall, Roche Group is planning to launch its latest tool later this month. And while its SARS-CoV-2 Rapid Antigen Test will be available in markets accepting the CE mark, the company is expecting the filing for emergency use authorization (EUA) from the U.S. FDA. Roche’s test is a rapid chromatographic immunoassay intended for the qualitative detection of a specific antigen of SARS-CoV-2 present in human nasopharynx.
Baxter International Inc. has scored a win from the U.S. FDA, which has granted the de novo application for Theranova, the company’s novel dialysis membrane. For his part, Cowen’s Josh Jennings noted that de novo designations are rare in the dialysis space, echoing a company statement. “We think the de novo classification strengthens any argument for the uniqueness of the technology, which should help its commercial experience,” he added. “BAX had expected an FDA clearance in [second half of] '20, so this action falls on the early end of that range.”
Keeping you up to date on recent developments in cardiology, including: 3D printing of heart valve models; Findings challenge recommendations for antiplatelet treatment after TAVI; Telehealth could help those with high BP avoid heart attack, stroke.
Neurovascular bioelectronics medicine company Synchron Inc. has received good news in the form of a breakthrough device designation for its Stentrode. The U.S. FDA granted the designation for the fully implantable medical device that can translate brain activity or stimulate the nervous system from inside a blood vessel. As a bonus for patients, the device does not require open brain surgery. “As this is a first-of-its-kind device, we look forward to working closely with the FDA to prioritize development of the Stentrode and ensure access for patients with paralysis, as well as lay the groundwork for future indications for brain-computer interfaces,” said Thomas Oxley, CEO of Synchron.
Foundation Medicine Inc.’s string of 2020 wins continues, with the U.S. FDA giving its thumbs up to Foundationone Liquid CDx, the company’s comprehensive pan-tumor liquid biopsy test.
Hologic Inc., which focuses on women's health, reported Aug. 25 that it was acquiring Acessa Health Inc., a company that has developed a minimally invasive treatment for fibroids. It is offering about $80 million in cash plus contingent payments based on future revenue growth.
Medtronic plc reported first-quarter worldwide revenue of just over $6.5 billion, a decrease of 13% as reported. As Cowen’s Josh Jennings wrote, the company’s results were better than expected, with an organic revenue growth decline of 17% vs. the Street’s prediction of a 25% decrease.
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.
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.
Exo Imaging Inc. closed a $40 million series B+ funding round that is earmarked to help with the development of a hand-held ultrasound device and cloud-based workflow software platform. The funding follows a series B round in August 2019 that reeled in $35 million and brings the company’s total raise to nearly $100 million.
