The FDA granted breakthrough device designation to Volumetrix LLC for its NIVAHF monitoring system for heart failure. The device is the first application of the company’s noninvasive venous waveform analysis (NIVA) technology, which captures and analyzes vital information about blood volume to assess patient status.

The controversy over the use of paclitaxel in devices for the peripheral vasculature has taken a significant bite out of sales, but a new study serves to help reverse the narrative regarding mortality. According to a study of more than 168,000 Medicare patients, stents and angioplasty balloons coated with paclitaxel (PTX) were non-inferior to non-coated devices for mortality out to nearly three years, a finding that may encourage clinicians to return to normal utilization patterns and thus help to restore sales volumes.

Neovasc Inc. has hit pause on its Tiara transfemoral mitral valve replacement (TF) program and is cutting its workforce by more than 40%, citing the additional time and substantial investment required to develop the program and the associated costs. The changes are expected to extend its cash runway from about 18 months to more than three years. The changes were implemented with about 18 months to remain solvent as part of a series of actions to focus on enhancing current shareholder value and focusing investments on near-term value drivers, namely the Reducer stent and the Tiara transapical mitral valve replacement (TA) system.

PARIS – Affluent Medical SAS aims to raise $40 million on the Euronext Paris regulated market to finalize the development of three minimally invasive prostheses in urology and interventional cardiology. The Aix-en-Provence, France-based med-tech will issue 3,387,210 new shares. Affluent has already received subscription pledges exceeding $24 million, including $12 million from funds managed by Paris-based Truffle Capital.

The FDA granted Neurescue a "two-fer" on its intelligent balloon catheter for aortic occlusion with 510(k) clearance for emergency control of hemorrhage and investigational device exemption for use in cardiac arrest. By inflating a soft balloon at diaphragm level, the device dramatically increases perfusion to the heart, brain and lungs within a minute of deployment via the femoral artery.

Medtrace Pharma A/S raised $30 million in a series B round to ramp its platform for production, infusion and analysis of ¹⁵O-water in medical imaging. Swiss-based Swisscanto Invest, along with fund managers ATP and Bankinvest group from Denmark, are the lead investors. “We can now ramp our European and U.S. expansions plans in myocardial perfusion imaging and in other indications in need of perfusion data,” Martin Stenfeldt, CEO and co-founder of Medtrace, told BioWorld.

Medtronic plc is ceasing global sales and distribution of its Heartware ventricular assist device (HVAD) due to safety concerns. The news sent Medtronic shares down about 1% in early morning trading. The Dublin-based company said it made the decision to stop selling the HVAD left ventricular assist device after clinical comparisons found a higher frequency of neurological adverse events, including stroke and mortality, with its heart pump device vs. other circulatory support systems.

Alivecor Inc. has elevated its patent dispute with Apple Inc. to the U.S. International Trade Commission (ITC) in a move that could damage the latter’s foray into digital health. Alivecor is alleging that Apple, of Cupertino, Calif., has infringed on Alivecor patents for electrocardiogram monitoring technology, a development that may foreshadow a continuing legal struggle between the two companies for a large and rapidly growing market.

Edwards Lifesciences Corp. has won the FDA’s nod for its Acumen hypotension prediction index (HPI) software with the Acumen IQ finger cuff. Prior to receiving this 510(k) clearance, the low blood pressure prediction software was only available for patients using an invasive arterial line. The Acumen HPI software uses data gleaned from the Acumen IQ cuff, along with machine learning, to alert clinicians if a patient is at risk of hypotension, drops in pumping pressure that reduce the flow of oxygenated blood and nutrients to the body’s vital organs.

The FDA has granted breakthrough device designation to Micro Interventional Devices Inc. (MID) for its Mia-T percutaneous tricuspid annuloplasty system. The company will enjoy increased communication with the agency and priority review as it pursues regulatory approval.