Botox specialist Allergan plc is acquiring body-contouring product maker Zeltiq Aesthetics Inc. in a deal for about $2.48 billion. Shares of Pleasanton, Calif.-based Zeltiq Aesthetics Inc. (NASDAQ:ZLTQ) were at an all-time high, up 13.2 percent closing at $55.93 on Monday. Zeltiq has developed the Coolsculpting system, an FDA-approved technology that uses a cooling mechanism to reduce the appearance of stubborn fat. Dublin-based Allergan, which has been on a buying spree since its failed merger with Pfizer Inc. last April, said it would close the Zeltiq acquisition in 2Q17. For the past few years Zeltiq has...

Intensive efforts to improve artificial pancreas technology continue apace even as Medtronic plc prepares to launch the first FDA-approved iteration by this summer. The National Institutes of Health (NIH) is highlighting four pivotal trials that it's funding, which are slated to start over the next few years. Two of the trials involve Medtronic: one for a next-generation iteration from the Dublin, Ireland-based company and the other using existing Medtronic insulin pump/continuous glucose monitor (CGM) equipment in combination with a novel algorithm. Another of the NIH-backed pivotal artificial pancreas trials relies upon an assemblage of software...

Med-tech startup Flow Forward LLC said it has raised a total of $7 million in its series A round. The news comes around the same time the private company reported completing two studies evaluating its Arteriovenous Fistula Eligibility (AFE) system for use in hemodialysis patients. The Olathe, Kan.-based company's device is a small, minimally invasive blood pump system designed for temporary use to rapidly dilate peripheral veins through flow-mediated vascular dilation prior to arteriovenous fistula (AVF). The AVF procedure establishes a direct...

Health care data analytics start-up Intensix Ltd. brought in $8.3 million in its series A funding round. The Netanya, Israel-based company has developed a real-time predictive analytics platform for the early detection of patient deterioration in the intensive care unit (ICU) and high acuity departments of hospitals. Pitango Venture Capital led the round. The funding will be used to boost the company's sales and marketing operations in North America and to expand and accelerate the development of its predictive analytics platform. Intensix was founded by Gal Salomon, who also serves as its CEO. The company's...

PARIS – In the face of an expanded scope of scrutiny by French health authorities triggered by the death of the first patient in the pivotal trial for its artificial heart, Paris-based Carmat SA reported the suspension of the clinical study. The company revealed the patient's death "was due to an interruption in the power supply system, following an incorrect battery handling by the patient, as a result of which the prosthesis stopped functioning." Carmat confirmed that the prosthesis functioned correctly, which is consistent with the announcement in November 2016 that "analyses undertaken have not...

Cardiovascular genomic's specialist Cardiodx Inc.'s test to detect obstructive coronary artery disease (CAD) received long-term validation from a study published in this month's American Heart Journal. The Corus CAD test was evaluated in a genomic sub study of the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE), which was sponsored by the National Heart, Lung and Blood Institute. PROMISE results come shortly after the Redwood City, Calif.-based company raised $18.1 million in equity financing from a total offering amount of $41.8 million, last month. The 2,370-patient study showed that individuals with low Corus...

Elekta AB has received FDA clearance for its Venezia applicator for gynecological brachytherapy. The device is positioned to treat advanced-stage cervical cancer and has had a CE mark since last year. The Stockholm-based company said Venezia has a design that facilitates predefined and consistent needle placement to access difficult to reach tumors that extend outside of the cervix. Elekta said the use of interstitial brachytherapy in patients with tumors that extend outside of the cervix may be underutilized due to the limited reach of existing applicators and the complexity of precisely targeting tumor tissue. Data...

The U.S. Food and Drug Administration has given its first nod to a molecular test developed by Abbott Laboratories for the Zika virus for use to test whole blood. This expands upon an existing use of the test from the Abbott Park, Ill., company; it had already received emergency use authorization for use to test serum, plasma and urine. The whole blood test is expected to enable diagnoses over a longer period of time, up to two months after symptom onset, rather than about a week. That's important since the symptoms of Zika virus are...

Medtronic plc has won FDA clearance for its Cardioinsight noninvasive 3-D mapping system. The device, which has been approved in Europe for nearly five years, is used to improve the mapping of electrical disorders of the heart. The Dublin-based company first gained access to the device through its $93 million acquisition of Cleveland-based Cardioinsight Inc. (See Medical Device Daily, June 22, 2015.) The device could become a safer and less costly alternative to traditional cardiac mapping procedures, which are typically accomplished by inserting a catheter into the heart via an artery or vein. The Cardioinsight...

As is widely known, the FDA is facing a change in leadership and has inked a memorandum staking out the agency's current position on the off-label promotion problem. Despite the continued vetting of the problem by the agency, the memo comes across as little more than a reiteration of the FDA's long-held views on commercial speech. Indeed the memo contains some suggestions that seem beyond rational consideration, but may reflect a certain anxiety among the agency's legal staff. Many drafts, little actual guidance To recap, the Medical Information Working Group, a loosely...