Materialise said today that FDA has provided 510(k) clearance for its Mimics Enlight — a cardiovascular procedure planning software creating accurate 3D printed heart models. The Belgian 3D printing software and services company, which has its U.S. offices in Plymouth, Minn., plans the first release of the software to focus on planning for complex transcatheter […]
Zoll buys AED developer Cardiac Science
Zoll Medical said today that it inked a deal to acquire Cardiac Science Corp., and its portfolio of automated external defibrillators. Deerfield, Wis.-based Cardiac Science operates in North America, Europe and Asia. The company has installed more than 500,000 units in nearly 100 countries, according to Zoll. The two companies did not disclose financial terms […]
Want to save your medical device as a souvenir? It’s easier than you might think
Keeping a medical device that was inside you — or even a removed body part — is actually easier than it might seem, according to a recent story in the Chicago Tribune. Just ask Barbara Brotman. Brotman is a senior assistant director of development communications for University of Chicago Medicine and Biological Sciences and a […]
Biotronik touts success of its resorbable magnesium scaffold
Biotronik said today that new data from a European patient registry strengthen the clinical evidence for its Magmaris resorbable scaffold device, its procedure success and safety profile. The target lesion failure (TLF) rate at 12 months was 4.7%. Cardiac death occurred in 0.1% of the 800 patients who received Magmaris and scaffold thrombosis in 0.6%. […]
FDA clears Gore’s Cardioform ASD occluder
W.L. Gore & Associates said today that it won FDA premarket approval for its Gore Cardioform ASD occluder designed for the percutaneous closure of ostium secundum atrial septal defects. Approval came supported by data from the pivotal stage of Flagstaff, Ariz.-based Gore’s ASSURED clinical study, which reported a 100% closure success rate at six months post-implant. […]
Ancora Heart launches 2nd AccuCinch ventricular repair system feasibility study
Ancora Heart said yesterday that it launched a U.S.-based early feasibility study looking to evaluate its AccuCinch ventricular repair system intended for treating patients with reduce ejection fraction systolic heart failure. The first patient has already been enrolled in the study at UPMC Pinnacle Harrisburg by Dr. Hemal Gada and Dr. Mubashir Mumtaz, Santa Clara, […]
Stealthy cardiac tech dev Spectrawave raises $16m
Stealthy Spectrawave has raised approximately $16.4 million in a new round of equity financing, according to a recently posted SEC filing. Spectrawave is developing photonic imaging technology intended to improve cardiac outcomes, according to its website. The Waltham, Mass.-based company has not yet revealed any details of the technology. Money in the round came from […]
Best Buy to retail AliveCor’s KardiaMobile
AliveCor said yesterday that it has inked a strategic partnership deal with Best Buy to offer its KardiaMobile electrocardiogram devices at their retail locations across the U.S. The Mountain View, Calif.-based company’s KardiaBand is a wrist-worn electrocardiogram device designed to detect atrial fibrillation and normal sinus rhythm. AliveCor said that the deal marks the first time […]
3 European medtech startups you should know
Medical device startups focus on the creation of new devices and applications that can solve problems in healthcare. Valuer.ai — an AI-based startups search and evaluation platform — has compiled a list of European medtech startups from each country that are using contemporary technology to make medical processes easier. From 3D-printed orthotics and prosthetics to sensors to […]
Plaintiff’s lawyers seek legal fees in $12m Thoratec settlement
Attorneys representing investor Bradley Cooper are seeking approximately $3 million from Abbott (NYSE:ABT) owned Thoratec in legal fees and $392,445 in expenses for a lawsuit that the company settled in February for $11.9 million. In the original case, plaintiffs claimed that Thoratec and some of its officers hid facts about its Heartmate II heart pump’s thrombosis rate […]
Medtronic wins FDA nod for SelectSite catheter
Medtronic (NYSE:MDT) said today that it won FDA clearance for its SelectSite C304-HIS deflectable catheter for placing pacemaker leads. The 510(k) clearance covers lead placement for procedures involving His-bundle pacing, Fridley, Minn.-based Medtronic said. The catheter is designed for use with the SelectSecure MRI SureScan Model 3830 lead, which the company claims as the only […]
MassDevice Network
@MassDevice
LinkedIn
YouTube