GE, Golden Meditech ink cord blood storage deal

Share

GE Healthcare, Golden Meditech

GE Healthcare (NYSE:GE) and Golden Meditech said this week they inked a strategic collaboration deal to provide GE’s integrated and automated digital systems and solutions to Golden Meditech for use in its umbilical cord blood cryopreservation processes.

Hong Kong-based Golden Meditech said that umbilical cord blood contains rich hematopoietic stem cells which could facilitate reconstruction of hematopoietic and immune systems with possible applications in stem cell transplantation and other treatments.

Through the partnership, Golden Meditech will use fully automated cell processing systems and associated tools and kits to meet requirements for cord blood processing, according to a press release.

In September, GE Healthcare said it won FDA 510(k) clearance for its Senographe Pristina Dueta, which it claims is the 1st patient-assisted mammography device that allows women to control their own compression during the examination.

HeartFlow wins CMS new tech payment classification for FFRct analysis

Share

HeartFlow said today that the Centers for Medicare & Medicaid Services finalized a new technology ambulatory payment classification for its HeartFlow FFRct analysis designed to help diagnose suspected coronary artery disease.

Under the newly finalized payment decision, Medicare-enrolled hospitals will be eligible for reimbursements of $1,450.50 for each technical component of the FFRct analysis. The new rules are set to take effect on January 1, 2018.

“CMS’s decision to assign a New Technology APC for FFRct technology for Medicare recipients is a recognition of the value of this technology and its demonstrated ability to reduce the number of invasive diagnostic coronary angiography procedures and help medical centers reduce costs. The HeartFlow Analysis is an important tool in helping us assess patients with suspected coronary artery disease and better understand how their coronary blockages affect blood flow to the heart,” Dr. Pamela Douglas of Duke University said in a press release.

Redwood City, Calif.-based HeartFlow’s FFRct technology works by taking the data from a standard CT scan and applying algorithms that result in a color-coded 3D “map” detailing the changes in flow across coronary lesions.

“The decision by CMS will help in the diagnosis and treatment of patients with suspected CAD and means the number of patients over age 65 who will have access to this technology will significantly increase. At our center, the use of the HeartFlow FFRct Analysis is transforming how we diagnose and treat patients with coronary artery disease, helping us move closer to achieving the triple aim of improving the patient experience, improving the health of our patients, and reducing healthcare costs at our institution.” Dr. Daniel Simon of the Cleveland Medical Center said in a prepared statement.

In late August, HeartFlow said it won positive medical policies for its HeartFlow FFRct fractional flow reserve analysis system from 3 separate Blue Cross Blue Shield providers.

Cerus lowers Intercept sales guidance after Fresenius Kabi supply snafu

  • ‘Radiating Shoe Sales’

    By: Vanessa Burrows Since the discovery of X-rays in the late 19th century, the technology has enhanced health care in a variety of ways. Like many cutting-edge scientific developments, however, it also has inspired uses of uncertain therapeutic value. That was the case with the shoe-fitting fluoroscope, the subject of the latest episode of FDA’s […]

  • Invetech announces senior management changes

    Invetech – provider of instrument development, custom automation and contract manufacturing – has announced refinements to its senior management structure as it continues to pursue growth in the diagnostics, connected health and cell therapy automation markets. Anthony Annibale has accepted the role of  global VP of sales, diagnostics and healthcare. Annibale is a proven product […]

  • Apple Watch detects atrial fibrillation using built-in technology

    The Apple Watch can automatically detect atrial fibrillation (AF) using its built-in heart rate sensor and artificial intelligence, according to a new study. The research used a deep neural network that was based on photoplethysmographic (PPG) sensors that are frequently found in smart watches. When paired with an artificial intelligence-based algorithm, Apple Watch’s heart rate […]

  • NAMSA announces partnership with Naglreiter

    Medical research organization NAMSA today announced a partnership with the Naglreiter medical device development organization, which focuses on medical device design, development and manufacturing. For nearly 50 years, NAMSA has focused on offering the most critical services required to accelerate time-to-market and reduce costs for medical device research clients across the world. Consistently recognized as a pioneer in […]

  • Resonetics adds applications development lab and nitinol processing to San Diego facility

    Resonetics has announced its plans to add a Lightspeed ADLTM application development lab to its manufacturing site in San Diego. The site will offer a variety of micro manufacturing tools to service medical device and diagnostics customers and will feature various laser wavelengths optimized for polymers, glass and metals. In addition, the San Diego facility […]

  • TransEnterix CEO: Robotic surgery has a big problem

    Todd Pope has been working in the surgical robotics space for over a decade. As the CEO of TransEnterix, which has developed Senhance surgical assistance device, Pope believes the surgical robotics market is about to explode. But before it can take off, Pope noted that players have to address a really big problem with robotic […]

  • Stratasys unveils multi-cell additive manufacturing platform

    Stratasys has launched its Continuous Build 3D Demonstrator multi-cell additive manufacturing platform for low-volume, continuous production. The Continuous Build 3D Demonstrator is a modular unit that has multiple 3D print cells working together through a central, cloud-based architecture. The platform is designed to create parts in a continuous manner with very little minor operator intervention. […]

  • Spectrum Plastics Group: Why the merger took place

    The M&A deal creating Spectrum Plastics Group is but the latest in a wave of consolidations taking place among medical device industry outsourcers. Mauricio Arellano, president of Spectrum’s medical division, thinks 2 trends are driving the consolidations: the need of OEMs to provide truly disruptive innovations to meet health providers needs for value-based care, and […]

  • FDA and NIH launch new clinical trial protocol writing tool

    By Stewart Eisenhart, Emergo Group US regulators at the Food and Drug Administration and the National Institutes of Health (NIH) have published a new writing tool for use in applying for regulatory approval to conduct clinical trials for medical devices and pharmaceuticals. Get the full story here at the Emergo Group’s blog. The opinions expressed […]

  • 5 officials running healthcare under Trump

    President Donald Trump’s critics complain that the president has yet to make hundreds of appointments to midlevel positions. But at least with healthcare, we’re starting to get a clearer picture of who is in charge. Just on May 10, the U.S. Senate confirmed Dr. Scott Gottlieb as FDA commissioner. Here are 5 top officials shaping […]

  • Gut microbiomes can predict non-alcoholic fatty liver disease

    There is a microbe in stool samples that can predict non-alcoholic fatty liver disease (NAFLD), according to researchers at the University of California San Diego School of Medicine. NAFLD occurs when there is a build up extra fat in liver cells that isn’t caused by alcohol, according to the American Liver Foundation. The liver has […]

  • CytoSorbents touts Refresh trial study data

    CytosorbentsCytoSorbents (OTC:CTSO) today presented results from the Refresh trial of its CytoSorb blood purification technology, touting that the trial met its safety goals and that treatment reduced toxic inflammatory mediators during complex heart surgery.

    Data was presented at the American Association for Thoracic Surgery’s centennial conference in Boston this week.

    The Monmouth Junction, N.J.-based company’s CytoSorb is an extracorporeal cytokine filter, made up of biocompatible, porous polymer beads that use pore capture and surface adsorption to remove toxic substances from the blood and other bodily fluids.

    The prospective, randomized trial looked to evaluate the safety and feasibility of the CytoSorb in treating deadly inflammation in critically-ill and cardiac surgery patients between 18 and 80 years.

    Results from the study indicate that valve replacement surgery was the highest risk procedure for peak plasma free hemoglobin, and that treatment with the CytoSorb increased reductions in peak pfHb levels by 26% at 3.5 hours and 38% at 4 hours. Treatment also resulted in statistically significant decreases in activated complement C3a and C5a during surgery, according to CytoSorbents

    The company said that the trial achieved its primary safety endpoint with a favorable adjudication of all serious adverse events, and no significant differences in the rate of adverse events or serious adverse events at 30 days. No unanticipated adverse device effects were reported.

    “We are pleased to report on this first multi-center U.S. trial demonstrating the safe and easily implemented use of CytoSorb during high risk complex cardiac surgery.  Inflammation and toxic injury from excessive plasma free hemoglobin and activated complement are well-known insults that are associated with organ injury such as acute kidney injury, stroke, lung injury, and other complications.  The finding that complex valve replacement procedures generate high levels of pfHb, and that CytoSorb can significantly reduce pfHb and activated complement in this population, represents a potentially important advance in the field.  In a future larger study, we plan to correlate the reduction of pfHb and activated complement in this enriched at-risk population with reduced organ dysfunction and injury, while confirming the risk/benefit of the therapy,” principal investigator Dr. Joseph Zwischenberge of the University of Kentucky College of Medicine said in a press release.

    In January, CytoSorbents and  Fresenius Medical Care (NYSE:FMS) said that they expanded the terms of their partnership and added a co-marketing agreement for the CytoSorb blood absorber in countries where the therapy is available.

    Report: Theranos trades extra shares for vows not to sue

    Theranos

    Theranos is looking to avoid lawsuits from investors by offering them additional shares if they promise not to sue the company, according to a Wall Street Journal report.

    Shares to be offered will come from CEO Elizabeth Holmes personal stake in the company, which may cause the founder to lose a majority ownership in the blood-testing company, sources close to the company told the WSJ.

    The arrangement will cover investors who joined in Theranos’ most recent $600 million round of financing, but will not cover investors from earlier rounds. Investors approved in the deal would receive 2 times the shares they originally bought, according to the report.

    The deal has won approval from the company’s board, but is still under consideration by investors, according to the paper.

    Certain investors are not participating in the deal, including San Francisco-based hedge fund Parter Fund Management and Rupert Murdoch, who the company will reportedly buy back shares from at $1 per share, according to the WSJ.