Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. St. Jude launches EnSite Precision cardiac mapping system in EU
St. Jude Medical said today it fully launched its EnSite Precision cardiac mapping system and associated tools in Europe, expanding from an earlier limited release.
The St. Paul, Minn.-based company touted more than 100 installations of the device across Europe so far, supporting more than 5,000 ablation procedures after a targeted release it expanded in April. Read more
4. Enable Injections lands $30m Series A for large-volume injector
Enable Injections Inc. said today that it closed a $30 million Series A round to bring its large-volume injector to market.
The Cincinnati, Ohio-based company’s Enable Injector adheres to a patient’s body and delivers biologic doses as large as 50 milliliters. It can be used at work or at home, providing an alternative to costly intravenous infusions in a healthcare setting. Read more
3. HHS: Medicare spent $1.5B on faulty cardiac devices
Medicare spent approximately $1.5 billion on defective heart devices implanted in thousands of beneficiaries, according to a report from the Department of Health and Human Services released in late September.
The cost was associated with 7 specific cardiac devices implanted into 375,991 beneficiaries, according to the report, all of which were recalled or which had high failure rates. Read more
2. Vascular Solutions recalls Twin-Pass dual access caths
Vascular Solutions said yesterday it initiated a nationwide recall of its Twin-Pass dual access catheters due to a potential for excess material in the catheter that could dislodge and pose a risk for embolism.
The FDA has labeled the recall as Class 1, indicating “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency. Read more
1. Samsung Biologics IPO could reach $2B, company value above $8B
Biotech drug contract manufacturer Samsung BioLogics could pull in as much as $2 billion through an initial public offering, according to regulatory filings posted this week. The figures would position it as South Korea’s 3rd-largest IPO.
BioLogics, which is 47.8% owned by Samsung Electronics, this week gave new information on the planned offering, which would value the company at up to $8.2 billion as it seeks regulatory clearance for a new cancer treatment. Read more