CHF Solutions (NSDQ:CHFS) recently announced that it has promoted Nestor Jaramillo Jr. to the president and COO spot at the company. Jaramillo’s promotion was effective July 1. Jaramillo has been at the Eden Prairie, Minn.-based fluid overload treatment developer since May 2019, focusing on commercial growth. “Nestor has had a strong impact on our commercial success […]
FDA clears Nonin Medical flagship product
Nonin Medical (Plymouth, Minn.) announced today that it has received 510(k) clearance for its flagship product — the CO-Pilot wireless handheld multi-parameter system. The handheld, wireless CO-Pilot is meant to make it easier for EMS, firefighters and military personnel to measure a person’s key vital signs following a cardiac arrest, traumatic injury, carbon monoxide or […]
U.S. investing $42m to boost BD syringe and needle production
HHS’s Biomedical Advanced Research and Development Authority is helping BD expand operations and manufacturing capacity in Nebraska to boost syringe and needle supplies for an eventual COVID-19 vaccine. Becton Dickinson (NYSE:BDX) said today that the total project will cost $70 million, with BARDA providing $42 million. The company expects the new capacity to be online within […]
CVRx raises $50m to support Barostim Neo commercialization
CVRx has raised $50 million in its latest round of equity financing — money the company will use to support the U.S. commercialization of its Barostim Neo heart failure treatment device. New investors Strategic Healthcare Investment Partners and Vensana Capital led the new funding round — with participation from other new investors, Hatteras Venture Partners […]
Medtronic Linq II insertable cardiac monitor gets OK in U.S., Europe
Medtronic (NYSE:MDT) announced today that its Linq II insertable cardiac monitor has received FDA clearance in the U.S., as well as a CE Mark in the EU. The Linq II boasts remote programming. That means a person with the Linq II implanted inside of them doesn’t need to return to the doctor’s office or hospital to […]
BD launches COVID-19 antigen test that can produce results in 15 minutes
Becton Dickinson (NYSE:BDX) announced today that it’s received an FDA emergency use authorization for its COVID-19 antigen test, which the company will start shipping this week. BD plans to ramp-up manufacturing capacity to 2 million tests per week by the end of September, with 10 million tests produced by the end of September. The tests run […]
OneProjects raises $12m for development of its cardiac imaging system
OneProjects — an Irish-German cardiac imaging startup — announced today that it has raised $12 million (€11 million) in a Series A round. LSP, based in the Netherlands, investing from its LSP Health Economics Fund 2, and the Atlantic Bridge University Fund (Ireland), led the round, with participation from Enterprise Ireland and a selection of […]
Abiomed touts results of U.S. study of its latest Impella heart pump
Abiomed (NSDQ:ABMD) says a study of U.S. patients receiving the new Impella 5.5 with SmartAssist found that 84% survived to explant and 76% experienced native heart recovery. The study — published in the July edition of the American Society for Artificial Internal Organs (ASAIO) Journal — examined the outcomes of the first 55 patients treated with Impella […]
Medical device litigation and COVID-19: What you need to know
The COVID-19 pandemic is creating a new set of medical device litigation challenges — but also a chance for an industry reset. One of Greenberg Traurig’s top medtech litigation lawyers shares her insights. Sara Thompson doesn’t take any guff when she tells people that she defends medical device and pharmaceutical companies from lawsuits. “I say, […]
COVID-19 vaccines need to work at least half of the time, FDA says
FDA expects that any COVID-19 vaccine it licenses should prevent the disease or decrease its severity in at least 50% of people vaccinated, according to guidance that the agency released today. The recommendation, which FDA said reflects the advice the agency has provided vaccine developers in recent months, was part of an overall document called […]
Pantheon Surgical acquires sacroiliac screw system
Pantheon Surgical recently announced its acquisition of the Topaz/Compressive sacroiliac screw system. Pantheon Surgical acquired the technology from Osseus Fusion Systems, which will continue to distribute the Blue Topaz/Compressive system. Financial terms of the deal were undisclosed. “I’m excited about the transfer acquisition of the Blue Topaz/Compressive system into the Pantheon armamentarium. I look forward […]