Cleveland Clinic & Candescent partner to improve radiology

The Cleveland Clinic and Candescent Health said they have inked a multi-year deal to improve radiology care and create a nation-wide cloud-based radiology network.

As part of the collaborative effort, the Cleveland Clinic will help Candescent develop clinically focused products with the goal of improving the efficiency and performance of radiology practices.

“The healthcare model of the future requires that we find better, more efficient ways to provide services. That will only happen through technological advances that lower costs, drive efficiencies and allow doctors to put patients first. This partnership will help the radiology community improve quality and productivity by expanding technology and clinical expertise to health systems throughout the country,” Cleveland Clinic CEO Dr. Toby Cosgrove said in a press release.

As part of the deal, the Cleveland Clinic will have the opportunity to make equity investments in Candescent Health in the future, the companies said.

Candescent is developing the RadPerform platform, which includes a cloud-based, data-driven workflow components, 24/7 case and workflow monitoring systems and performance analytics, the company said.

“We are thrilled to be working with a healthcare innovator and leader like Cleveland Clinic to accelerate what we believe is an essential shift in the radiology care model that drives greater healthcare value on a nationwide basis. Cleveland Clinic not only has the foresight to understand that radiology is undergoing significant change, but is willing to lead radiology through that crucial transformation. This fundamental reengineering of the radiology care model will have an enormous positive impact on patients, referring providers and healthcare systems overall,” Candescent Health CEO Scott Seidelmann said in a prepared statement.

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Senseonics implantable CGM pivotal meets interim endpoint

Senseonics said today a clinical study of its implantable, long-term continuous glucose monitoring system met its interim phase primary effectiveness and safety endpoints.

Senseonics is developing micro-sized sensors and connected smartphone apps for glucose monitoring. The device is inserted into a patients upper arm, just below the skin, and can connect wirelessly to a smartphone application, the company said.

“The promising interim results from the Precise study, as well as the subsequent submission of our CE mark application, are major milestones for the company. When it receives clearance, our 90-day CGM system will be the longest-lasting glucose sensor that is safe and accurate for people with diabetes to use,” CEO Tim Goodnow said in a press release.

Data from 44-patients in the Precise study reported “strong accuracy throughout the first 90-days, with a mean absolute relative difference of 11.4% in the 75 to 400 mg/dL range when compared to YSI blood reference values.

The study reported that 84% of sensor value were within 20% of the YSI reference, and there were no significant adverse events related to use of the system.

“Overall our patients were very satisfied with the device and regretted that they couldn’t continue using it after the trial,” lead investigator Dr. J. DeVries of the University of Amsterdam said in a press release.

Subjects in the study underwent sensor insertions on the 1st day and used the transmitter and mobile app at home over the next 90, Senseonics said.

Senseonics said it has submitted a design dossier to obtain CE Mark approval in the European Union for the system, and plans to launch the product in Scandinavia 1st, followed by other European countries once it wins the CE Mark.

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Sanomedics deals Thermomedics, picks up Brace Shop

Miami, Fla.-based Sanomedics said today it approved the sale of its subsidiary Thermomedics to Positive ID and that it is acquiring orthopedic retailer The Brace Shop.

Thermomedics produces the Caregiver non-contact clinical-grade infrared thermometer, which is FDA cleared for measuring forehead temperature in adults, children and infants.

The sale of Thermodynamics could bring in as much as $2 million dollars, according to the company.

Last week, Positive ID announced details of the sale, saying it acquired the non-contact thermometer manufacturer for $750,000 up front and another possible $750,000 in 2016 and 2017 dependent upon reaching certain milestones.

Sanomedics said it is paying $250,000 in cash and issuing preferred stock to the owner of the Brace Shop for the purchase.

The Brace Shop sells orthopedic braces, physical therapy and rehabilitation eqiupment and reported annual revenues greater than $7 million, Sanomedics said.

Both deals are expected to close in the 4th quarter of 2015, Sanomedics said.

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MassDevice.com +3 | The top 3 medtech stories for October 28, 2015

Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 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.

 

3. AdvaMed taps LifeScience Alley’s Mandle to lead state medtech alliance

AdvaMed said it named Shaye Mandle, CEO of Minnesota’s LifeScience Alley trade association, as chairman of its State Medical Technology Alliance.

“The medical technology industry is a hallmark of U.S. innovation represented by a community of people dedicated to improving and saving lives. Now more than ever, medical technology has the opportunity to help deliver better and more affordable care to patients worldwide. The efforts of SMTA members are critical to providing our elected leaders with the information needed to ensure the full national and global impact of this vital industry,” Mandle said in prepared remarks. “It is an honor to have this opportunity to work together with our SMTA members, the team at AdvaMed, and our elected leaders to support our medical technology innovators in delivering life-changing innovations. Medical technology improves countless lives every day and I am proud to represent the people making it happen.” Read more

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2. Pennsylvania Supreme Court reverses Zimmer win in $20m knee implant lawsuit

The Pennsylvania Supreme Court reversed a state appeals court’s decision to overturn a $20 million verdict against Zimmer Biomet in a knee implant lawsuit.

Plaintiff Margo Polett claimed she re-injured her knees while making a Zimmer promotional video, after a double knee replacement procedure in 2006 using Zimmer’s Gender Solutions devices. Polett claimed that activities she engaged in for the video, including riding a bicycle and running on a treadmill, resulted in new damage to her knees. She and her husband sued for negligence, saying that injuries incurred during the filming of the marketing video resulted in 4 revision surgeries after she was left with persistent pain. A jury awarded Polett millions in damages after finding that Zimmer was 34% culpable. The jury also put 30% of the blame on Polett herself and 36% on the marketing firm Public Communications for its involvement with the ad. Read more

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1. Boston Scientific boosts guidance after strong Q3

Boston Scientific beat forecasts for its 3rd-quarter results, despite a swing to red ink, and raised its outlook for the rest of the year.

Marlborough, Mass.-based Boston Scientific posted losses of -$198.0 million, or -15¢ per share, for the 3 months ended Sept. 30, as litigation charges surged 228.8% to $457 million for the quarter. Read more

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How Exact Sciences built a DNA screening test for colorectal cancer

In a seemingly endless war on cancer, the best weapon remains early detection, according to Graham Lidgard, senior vice president of R&D at Exact Sciences Corp.

For Lidgard, and the rest of the team at the Madison, Wisc.-based molecular diagnostics maker, the battlefield is colorectal cancer, 1 of the most common, and deadliest, cancers in the world. Colorectal cancer primarily affects people age 50 and older, and among cancers that affect both men and women, it is the 3rd most common cancer and the 2nd leading cause of cancer-related death in the United States, according to the Centers for Disease Control and Prevention.

Lidgard has been with the team at Exact Sciences since 2009, when the company was down to a skeleton crew of true believers through its triumphant rise in 2014 when the U.S. Food and Drug Administration approved the company’s flagship product, Cologuard.

The Cologuard is a stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of certain kinds of abnormal growths that may be cancers such as colon cancer or precursors to cancer. The company says its test is 92% accurate for detecting cancer and that the test will help save thousands of lives in the U.S. by helping to detect this killer cancer earlier.

In this episode of DeviceTalks, MassDevice publisher Brian Johnson sits down with Lidgard to discuss the process behind bringing the Cologuard to market, his distinguished career, where the war on cancer stands today and why the team at Exact Sciences has an endless supply of poop jokes at their disposal.

Did you know that you DeviceTalks is also a live event? Check out our website to find out how you can participate in a live taping of this terrific podcast. Check out the lineup for our upcoming DeviceTalks West show in Irvine, California on December 9, 2015.

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FDA tells Aros Surgical to stop selling sutures, micro anastomosis clamps

The FDA published a warning letter it sent to Aros Surgical Instruments requesting the firm cease sales of its surgical sutures and micro anastomosis clamps.

The letter was sent based upon issues the agency found during a February inspection of the company’s Newport Beach, Calif. location.

The federal watchdog reported that the company had responded later in February to its initial concerns, and the FDA produced the warning letter in response. The letter addressed a list of violations the firm found.

The FDA said that changes to the sterilization method and materials of the company’s micro anastomosis clamp “may have affected the biocompatibility of the device,” the letter noted.

“The material change […], the addition of the curved design and changing the closing force of the clamps without any testing could significantly affect the safety and effectiveness of the device. Therefore, a new 510(k) is required for these changes,” the agency wrote in its warning letter.

Due to the significant changes, the FDA requested that the company cease any commercial distribution of the devices.

“Our office requests that AROSurgical Instruments Corporation immediately cease activities that result in the misbranding or adulteration of the above-referenced surgical sutures and micro anastomosis clamps, such as the commercial distribution of the device for the uses discussed above,” the FDA wrote.

The FDA inspector noted a failure to establish and maintain design control procedures, such as a failure to maintain control documentation for the design of its surgical sutures. The Agency said the company had responded to the violation, but found the responseinadequate.

Aros Surgical was hit with a failure to establish and maintain identification, documentation, validation or verification procedures for design changes before implementation. The FDA noted a few marked implemented design changes without identifying and documenting changes in sterilization methods. The Agency also said that it had received a response from the company that was inadequate.

The Agency said the company failed to guarantee its purchased products and services conformed to specified requirements, and had failed to maintain data to that end, including any changes from suppliers and contractors.

Failures to maintain device master records, records of documentation changes and a failure to ensure quality auditors do not have direct responsibility were also referenced by the FDA.

The FDA requested a response from the company within 15 days.

 

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TriReme appeals $20m loss to AngioScore

TriReme Medical and a pair of related companies are appealing a $20 million loss to AngioScore after a federal judge ruled that founder Eitan Konstantino violated his duties to AngioScore when he started TriReme, Quattro Vascular and QT Vascular.

AngioScore, which Spectranetics (NSDQ:SPNC) acquired last year for $230 million, accused Konstantino of breaching his fiduciary duties to AngioScore by developing the TriReme’s Chocolate balloon catheter, which competed directly with AngioScore’s AngioSculpt balloon. The Chocolate device won 510(k) clearance from the FDA in June 2014. The lawsuit, filed in June 2012 in the U.S. District Court for Northern California, also accused TriReme, Quattro and QT Vascular (SGX:5I0) of abetting in Konstantino’s alleged breaches.

Judge Yvonne Gonzalez Rogers agreed July 1, ordering Konstantino to disgorge $250,000 received for licensing the Chocolate rights and a 2.85% royalty on sales of the device. Gonzalez Rogers also ordered Konstantino to cough up his roughly 15 million shares in QT Vascular, which were worth about $2 million at their July 2 closing price of ¢13.5 (0.182 SGD), and any profits gleaned from sales of the stock and any remuneration from consulting on the Chocolate device. The judge also awarded nearly $3.0 million in lost profits and another $17.1 million in future lost profits to AngioScore on future sales from 2014 through the 2nd quarter of 2019.

TriReme, QT Vascular and Quattro Vascular appealed to the U.S. Court of Appeals for the Federal Circuit as soon as the decision was finalized Oct. 14 and asked the appeals court to stay the verdict pending its appeal, saying they will likely go bankrupt if forced to pony up.

“If this court does not stay execution of the judgment and waive the bond requirement, the companies will likely need to seek protection of the bankruptcy laws of the United States and their equivalent under the laws of the Republic of Singapore. In other words, executing on the judgment or collateralizing a bond for the full amount of the judgment would likely put the companies out of business,” they argued, according to court documents. “In contrast, plaintiff AngioScore cannot demonstrate any injury if the stay is granted. Indeed, driving corporate defendants into bankruptcy would only complicate and further delay any satisfaction of the money judgment.”

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