News

NEA takes the lead in Intact Vascular $39M Series B for PAD implant pivotal trial

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.

In new guidance FDA says it may approve devices for use by certain subpopulations only

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.

MIT spinout Myomo bags $5M to market its arm movement device for the neurologically impaired

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.

Physician services player Mednax buys into teleradiology with $500M vRad acquisition

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.

Boston Sci to challenge Nevro's spinal cord modulation patent

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.

Swedish med tech Elekta sees shares plunge on CEO swap and disappointing earnings

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 vein closure device recalled in Europe, Asia right around time of its U.S. launch

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 join forces for atrial fibrillation Dx

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.

FDA clears BD insulin infusion set developed with diabetes patient advocacy groups

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 quality improvement plan hit by recall at its troubled Cleveland facility

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.

Nature Biotech: Digital medicine on track to transform biomedical research

A publicly available article in Nature Biotechnology describes the growing influence of so-called digital medicine. 

ResMed down 15% as sleep apnea device fails in Phase III cardio trial

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.

Danaher buys water-systems maker for $13.8B, will split into two companies

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.

Glaucoma micro stent player Glaukos files to raise up to $86M in an IPO

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.

Seattle hospital sues Olympus over duodenoscope devices days before FDA panel meeting

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. 

 

South Korean team developing a 'smart' stent

A South Korean team is making progress on the fourth-generation stent.

Lab equipment players Danaher, Thermo Fisher in $10B+ bidding war for Pall

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, Cyberonics sort out post-merger structure, executive team

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 announces FDA approval of its 3rd-gen Cryoablation Catheter

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.