Startup Intact Vascular expects the $38.9 million Series B it has raised will help it get its peripheral artery disease implant and delivery system into pivotal testing and through the FDA. It's been a long time since the company's $15.5 million first institutional round in September 2012.
Advice for med tech entrepreneurs: Identify your customer and consider stakeholders' incentives carefully
The med tech ecosystem is diverse and teeming with myriad stakeholders, to the point that identifying the customer of a company or device can be challenging. Successfully creating a new company in med tech means identifying the customer and then finding a way to meet that group's needs.
After listening to the head of FDA's device arm (CDRH), Dr. Jeff Shuren, speak at several conferences, certain lines become predictable and repetitive. One of them is a boast about the January 2015 approval of the Maestro Rechargeable System on the basis of a patient survey which found that the subjects had a higher risk tolerance than anticipated.
Myomo has raised an initial $5 million tranche of a Series B round to help it to market its MyoPro Myoelectric Arm Orthosis. The round was from existing investors and led by Mountain Group.
Mednax has built its $6.7 billion business by providing specialized, outsourced services to hospitals for everything from neonatal, anesthesia, maternal-fetal to pediatric physician subspecialties. Now it's added teleradiology to that mix with the purchase of Virtual Radiologic (vRad) for $500 million in cash.
Nevro revealed that Boston Scientific is challenging its patent for "selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods," and promised to vigorously defend its intellectual property in the matter.
Cancer and brain disorder player Elekta plunged by 22% on news that its recent preliminary earnings results were well below its guidance and that it would bring aboard a new CEO. Executives attributed the earnings shortfall to miscalculations and overestimations of upcoming orders that failed to close.
Medtronic's Covidien was hit with a recall of 1,661 units of its VenaSeal Sapheon Closure System, a procedural delivery system for an adhesive that treats venous reflux disease by closing the affected veins in the lower leg.
Abbott and GE Healthcare are teaming up for a diagnostics collaboration aimed at improving treatment for patients with atrial fibrillation, planning to combine the companies' innovative technology to speed up diagnosis for individuals with heart rhythm disorders.
Becton Dickinson worked with diabetes patient advocate groups to develop its latest insulin infusion set, which is designed for improved insulin flow with reduced interruptions. Now the FDA has cleared the new infusion set based on BD FlowSmart.
Philips has made ramping up production of CT scanners at its troubled Cleveland manufacturing facility a centerpiece of its strategy following a €100 million ($112 million) quality improvement plan initiated last year. But a just-publicized recall of 918 nuclear gamma cameras made at the plant is a bad omen. It takes on added significance given the location's history of quality problems and importance to the company.
A publicly available article in Nature Biotechnology describes the growing influence of so-called digital medicine.
Cardiovascular problems can be associated with sleep apnea and it's commonly assumed that treatment of sleep apnea could have cardiovascular benefits. But a ResMed study found that its sleep apnea Adaptive Servo-Ventilation (ASV) treatment could actually worsen cardiovascular mortality and is ill-advised for a specific subset of patients.
With its largest acquisition ever, of filtration and purification system maker Pall for $13.8 billion, Danaher decided it had the ammunition to break itself into two publicly traded companies. The company's life science and technology units will retain the name Danaher, while a smaller company consisting of Danaher's diverse industrial businesses will be formed in late-2016.
Micro eye stent developer Glaukos has filed to raise up to $86 million in an IPO to advance an already marketed product, as well as to further develop three additional ones in its pipeline. In the last few years, Glaukos has significantly grown revenues but has held its net losses steady, suggesting that it could be on a path to achieving profitability.
As the FDA gears up for a panel meeting regarding duodenoscope devices linked to deadly bacterial infections, a U.S. hospital is joining forces with a patient's family to sue the largest manufacturer of the product.
A South Korean team is making progress on the fourth-generation stent.
Danaher and Thermo Fisher Scientific, the two biggest players in the laboratory equipment space, are fighting to acquire Pall, a maker of water filtration and purification systems that's valued at more than $10 billion. Final bids are due this week, the Wall Street Journal reported.
Sorin and Cyberonics offered a glimpse of what to expect after their roughly $3 billion all-stock merger completes. The pair have proposed a structure and an executive line-up for the new company, which has yet to be named. They expect to close the deal next quarter, with Cyberonics shareholders getting 54% and Sorin shareholders 46% of the resulting corporate entity.
Medtronic announced concurrent FDA and CE-mark approval of the latest generation of its stroke-fighting Arctic Front Advance ST Cryoablation Catheter. The device features a shorter tip designed to help physicians visualize the procedure in real time and enable increased maneuverability of the device.