After getting its 510(k) application rejected by the U.S. FDA for its AI-enabled Salix coronary anatomy software (SCA), Australian medical technology company, Artrya Ltd. scored regulatory approvals in the UK and in the EU.
Acotec Scientific Holdings Ltd. obtained marketing approval from the U.S. FDA for its peripheral support catheter Vericor, designed to enhance access to peripheral vessels.
Heart Test Laboratories Inc., doing business as Heartsciences, said an independent study shows its Myovista electrocardiogram (ECG) machine learning model could be a cost-effective way to predict and stratify cardiac risk.
Lepu Scientech Medical Technology (Shanghai) Co. Ltd. raised HK$567 million (US$72.2 million) in a Hong Kong initial public offering. Its shares opened at HK$29.8 apiece, increased over 2% in the middle of the day and closed at HK$29.15 on Nov. 8.
Medtronic plc reported six-month results from the full cohort of its Spyral HTN-ON MED study, showing a statistically significant reduction in office-based blood pressure, a key secondary endpoint. However, the trial missed its primary efficacy endpoint of a reduction in 24-hour systolic blood pressure, compared with a sham procedure.
The American College of Cardiology and the American Heart Association (AHA) released new guidelines for the diagnosis and management of aortic disease just ahead of this year’s AHA Scientific Sessions, which start Nov. 5 in Chicago. The update is the first comprehensive revision to the guidelines since 2010. Key recommendations address screening and diagnostic testing, imaging, patient involvement in care decisions and when to consider surgery.
Johnson & Johnson (J&J) agreed to acquire circulatory support device maker Abiomed Inc. for $380 per share in cash, corresponding to an enterprise value of $16.6 billion and a more than 50% premium on the share price as of the market close on Oct. 31. Abiomed shareholders will also receive a non-tradeable contingent value right that entitles them to $35 per share in cash, if certain milestones are met. That would bring the premium to 60%.
Jenscare Scientific Co. Ltd. has raised HK$225 million (US$29 million) in an initial public offering on the Stock Exchange of Hong Kong. Its shares opened at HK$28 per share, increased by over 9% in the middle of the day and closed at HK$28.25 on the first trading day of Oct. 10.
The U.K. NHS is implementing the use of Oxford, U.K.-based Genincode plc’s predictive genetic test for patients suffering with hypercholesterolemia and familial hypercholesterolemia (FH). The Academic Health Science Network for the North East and North Cumbria (AHSN NENC) is adopting the Lipid Incode test in Darlington following a successful pilot study which demonstrated the test can detect and diagnose people with high cholesterol, a known risk factor for the development of cardiovascular disease (CVD). It is the first commercial polygenic test for CVD to be implemented by the NHS.
Cleerly Inc. sees a bright future ahead after boosting its fundraising to date nearly five-fold with a $192 million series C. The new infusion brought the total invested in the company to $248 million, a solid endorsement of a company that hopes to transform cardiology with precision-based diagnostics that move away from indirect indicators to accurate measurements.
