HeartWare has found a way to pay for the expanded commercialization of its HVAD ventricular assist device and the development of its MVAD miniaturized ventricular assist device; the Boston-area VAD-maker has agreed be acquired by medtech giant Medtronic for $1.1bn in cash.
HeartWare has found a way to pay for the expanded commercialization of its HVAD ventricular assist device and the development of its MVAD miniaturized ventricular assist device; the Boston-area VAD-maker has agreed be acquired by medtech giant Medtronic for $1.1bn in cash.
The companies announced June 27 that both boards have agreed to a deal in which Medtronic will commence a tender offer for all outstanding shares of HeartWare common stock for $58
GE HealthCare anticipates most of the $0.85 EPS tariff impact will play out in the second half of 2025. Jay Saccaro, vice president and CFO, said the tariff-related burden is minimal in Q1 at about $10 million, rising to nearly $100 million in Q2 and then spiking to around $200 million each in Q3 and Q4.
Peerbridge Health is preparing to submit its next-generation ECG patch, CorMDx, for US FDA clearance this quarter, with plans to launch in the second half of 2025. The rechargeable device is designed for continuous, real-time heart monitoring from the hospital to home, aiming to detect early signs of heart failure and reduce emergency room visits.
Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.
Route 92 says it has reached a settlement with Q’Apel Medical over patent claims concerning its Tenzing delivery catheters.
The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.
The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.
States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.
