Consumer digital health company Livongo Health today announced the first cellular-enabled blood pressure monitoring system in the U.S. Cellular connectivity allows for easy checking and reporting from home, eliminating the so-called “white coat” syndrome that leads to unnecessary prescriptions for high blood pressure, the company said in a prepared statement. Nearly 65% of people already using Livongo […]
Gore’s aneurysm device for tricky anatomies implanted in Europe
The first European patient with a challenging anatomy has had the Gore Excluder conformable abdominal aortic aneurysm (AAA) endoprosthesis implanted, according to W.L. Gore & Associates. The next-generation endovascular aneurysm repair (EVAR) device is indicated to treat the broadest range of abdominal aortic aneurysms in patients with difficult anatomies. They include patients with proximal aortic neck angles […]
FDA clears 1st acute coronary artery perforation stent in 17 years
The FDA said today it approved Biotronik’s PK Papyrus covered coronary stent system intended to treat acute coronary artery perforations, touting it as the first such device to win clearance for that indication in 17 years. Coronary artery perforations can occur during percutaneous coronary intervention procedures and can create life-threatening conditions, the FDA said. In […]
Endotronix closes $45m Series D
Endotronix said today that it closed on a $45 million Series D round for the Cordella cardiovascular monitoring technology it’s developing. The Lisle, Ill.-based company said its latest raise was led by LSP and included Aperture Venture Partners, BioVentures Investors, Lumira Ventures, OSF Ventures, Seroba Life Sciences, SV Health Investors, Wanxiang Healthcare Investments and an unnamed […]
CHF Solutions eyes post-cardiovascular surgery market
CHF Solutions (NSDQ:CHFS) said yesterday it plans to expand into the post-cardiovascular surgery market, specifically with products for patients who need treatment for fluid overload and have failed diuretic therapy. The Eden Prairie, Minn.-based company said that it sees the expansion into the post CV surgical market as a “natural next step” in its commercial expansion, […]
Mylan launches generic Brevibloc heart injection
Mylan (NSDQ:MYL) said today that it launched a generic version of Baxter‘s (NYSE:BAX) Brevibloc heart drug in the U.S. The company’s injectable product, esmolol hydrochloride in sodium chloride, will be offered in single-dose plastic bags, according to Mylan. Get the full story at our sister site, Drug Delivery Business News.
Avinger shareholders accept $5 million settlement
The plaintiffs in a class action suit against Avinger (NSDQ:AVGR) have approved the $5 million settlement that the company offered in March. Shareholders sued the company and several of its officers and directors claiming that they made false and misleading statements about Avinger’s original product, Pantheris, in its 2015 initial public offering. Avinger makes image-guided, catheter-based […]
Report: New Apple Watch features on-board EKG scanning, AF detection
Apple (NSDQ:AAPL) today unveiled its new Series 4 Apple Watch which the tech company said now features on-board electrocardiogram scanning technology, according to a report from The Verge. The Cupertino, Calif.-based tech giant said that it won FDA approval for the watch, and touted the EKG addition as the first EKG product to be offered over-the-counter […]
FDA grants breakthrough designation to AliveCor’s KardiaK hyperkalemia software
AliveCor said this week it won breakthrough device designation from the FDA for its KardiaK software platform intended to screen for hyperkalemia, or elevated levels of blood potassium, without the need for drawing blood. The Mountain View, Calif.-based company said the KardiaK system uses a proprietary deep neural network intended to detect hyperkalemia using data from […]
Abiomed gets in on $7m round for RenalGuard affiliate Reprieve Cardiovascular
RenalGuard Solutions said today it closed a $7 million financing round joined by Abiomed (NSDQ:ABMD) to support its newly formed affiliate company Reprieve Cardiovascular. Milford, Mass.-based Reprieve Cardiovascular said that it is developing devices intended for patients suffering from acute decompensated heart failure. The technology is part of the company’s Guided Diuretic Therapy, which is being investigated as a […]
FDA warns Medtronic on CRM plants in Minnesota, Puerto Rico
The FDA this week released warning letters it sent to Medtronic (NYSE:MDT) over issues with cardiac rhythm management plants in Minnesota and Puerto Rico. The federal safety watchdog said inspections in April and May at both plants turned up problems related to the recall of CRM devices over high-voltage arcing, which led to the recall […]
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