𝗪𝗲𝗲𝗸𝗹𝘆 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗥𝗼𝘂𝗻𝗱-𝗨𝗽!
💰 Funding news 💰
Apreo Health announced that it closed an oversubscribed $130 million Series B financing round to support its Breathe airway scaffold. The company also plans to use funds to support regulatory activities related to the trial and early commercialisation efforts for Breathe. Karun Naga
CardiacBooster secures $10.8M for ventricular assist device. The funding, from Ireland’s Disruptive Technologies Innovation Fund (DTIF), supports the development of CardiacBooster’s unique mechanical cardiac support technology into a comprehensive medical device platform for treating cardiogenic shock. Florian Ludwig
Orchestra BioMed announced that it completed strategic transactions and equity offerings worth an expected $111.2 million. Proceeds support the continued advancement of its late-stage atrioventricular interval modulation (AVIM) therapy and Virtue sirolimus angioinfusion balloon (SAB) clinical programs. David Hochman
🚀 Regulatory Approvals & Product Launches 🚀
Instylla announced that it received #FDA premarket approval (PMA) for its Embrace hydrogel embolic system for the embolisation of hypervascular tumours (HVTs) in peripheral arteries ≤ 5 mm. Sean Boyle
Abbott launches its latest-generation MitraClip and TriClip G5 systems.
Respiree announced that it received a second FDA 510(k) clearance for its RS001 cardio-respiratory wearable device. The expanded FDA clearance covers the use of the wearable in home environments. Gurpreet Singh
Getinge announced that the European regulatory authorities reinstated the CE mark for its Cardiosave intra-aortic balloon pump. The Swedish medtech company faced a temporary suspension of the technology in March 2024.
🔬 Clinical Updates 🔬
Distalmotion announced new milestones as it continues clinical trial plans to support indication expansions for its Dexter surgical robot. The company continues to take the steps toward bringing the robot to ventral hernia repair, sacrocolpopexy, and myomectomy trials. Greg Roche
TransMedics, Inc. gets FDA green light to begin next-gen heart perfusion trial. Waleed Hassanein, MD
Synchron today presented the first-ever public demonstration of an individual using an Apple iPad controlled entirely by thought. Thomas Oxley
🔎 Mergers, Acquisitions & IPO's 🔍
Heartflow sets IPO price at up to $300M. With the IPO, the company expects to use proceeds to fund sales and marketing, fund R&D and for other general corporate purposes. John Farquhar
HistoSonics, Inc. announced a management-led majority stake acquisition by a syndicate of private and public investors. The deal for the histotripsy therapy platform developer is valued at approximately $2.25 billion.
Edwards Lifesciences announced that the U.S. Federal Trade Commission (FTC) seeks to block its planned $1.2 billion acquisition of JenaValve Technology, Inc..
Alcon to acquire STAAR Surgical in $1.5B deal.
Synova Partners
#medtech