News & Events

Mobile 3-D Imaging Equipment Demand Rises

Prices for mobile X-ray systems used in surgery or at the patient’s bedside are on the upswing as more providers are upgrading to 3-D compatible equipment. In data gathered from the latest Modern Healthcare/ECRI Institute Technology Price Index, buyers paid 33% more for systems than they did during the same period in the previous year, mainly because surgery, critical care, orthopedics and emergency department settings are opting to purchase newer and more expensive equipment with mobile capability. 

FDA Allows Marketing for Test to Provide Antibiotic Sensitivity Results and Identify Organisms Causing Bloodstream Infections

The U.S. Food and Drug Administration okayed the marketing of the PhenoTest BC Kit on Feb. 23, 2017. The test is the first to gather information about the likelihood of infectious organisms in the blood stream to respond to antibiotics. It tests for antibiotic sensitivity and also provides this information in a more timely manner, which can accelerate the antibiotic treatment recommendations. 

Johnson & Johnson Acquires GERD-Prevention Device Maker

A subsidiary of Johnson & Johnson has recently agreed to purchase competitor Torax Medical, a privately held company in Shorewood, Minn., for an undisclosed amount. Torax manufacturers the Linx Reflux Management System, a minimally invasive device created from interlinked titanium beads with magnetic cores. The ring-like device assists the lower esophagus sphincter to keep stomach acids from damaging the esophageal lining. GERD is commonly connected to a condition call Barrett’s esophagus, which is known to increase the risk of esophageal cancer. 

Marketing for First Newborn Screening System to Detect Metabolic Disorders Okayed by FDA

On Feb. 3. 2017, the U.S. Food and Drug Administration permitted the marketing of a system that will screen newborns for four rare Lysosomal Storage Disorders (LSDs). Call the Seeker system, it is designed to detect Mucopolysaccharidosis Type 1 (MPS 1), Pompe, Gaucher, and Fabry. This is the first newborn screen test of its kind to be okayed for marketing by the FDA for these disorders. 

Medical Journal Looks Back on First American Female MDs

In its November 2016 issue, Dotmed Healthcare Business Daily looks back in history on the opening of the first medical school for women in the United States in 1848. The school was called Boston Female Medical School, the first institution to train women for the medical field. The first woman to attend medical school in the U.S. was Elizabeth Blackwell, in 1847. While women were working as family doctors prior to Blackwell’s admission, they faced significant challenges in getting proper education. Classes for the new med school were held initially in a private home, with the inaugural class of 12 women travelling to the school from several Northeastern and Midwestern states. Among those first 12 women graduating with medical degrees in 1850 was Dr. Rebecca Lee, the first African-American female doctor in the United States. 

Duracon Uni-Knee Implants $9m Judgement Overturned in Appeals

After winning $9 million from TIG Insurance in 2014 for acquired company Duracon Uni-Knee, Strkyer ended back up in U.S. appeals court only to find the decision reversed. Stryker had brought the suit against TIG after problems arose with the implant that resulted in a payout of $7.62 million in liability suits. TIG refused to cover these losses, contending that Stryker settled the suits before getting TIG’s consent. As a result Stryker sued and won reimbursement in 2014 with a subsequent judgement in May 2015 that included interest and penalties. The U.S. Court of Appeals for the 6th Circuit overturned this judgement on Nov. 18, due to the TIG policy that required Stryker to obtain consent from the insurer before finalizing any settlements. 

FDA Clears Allengen’s Xen Gel Stent

Allergan’s Xen glaucoma treatment system, which includes Xen45 gel stent and the Xen injector, has recently been cleared by the FDA. The system is a treatment that lowers inner eye pressure and is used to manage refractory glaucoma, as an option following failed surgical treatment. The device is implanted through a procedure call the ab interno approach. This is a done with a cornea incision and vasodilation of the Schlemm canal. The tissue is disintegrated by applying bursts of high and low heat energy, which creates a new drainage channel with a permanent implant that reduces inner eye pressure.  

Manufacturer Admits to Selling Contaminated Ultrasound Gel

On July 6, 2016, New Jersey-based company Pharmaceutical Innovations, Inc., pled guilty to criminal charges and resolved a civil lawsuit arising from the company’s distribution of ultrasound gel contaminated with bacteria. The devices at issue are gels that doctors and hospitals use to take ultrasound scans, sonograms, EKGs and similar procedures. “Pharmaceutical Innovations shipped defective products that exposed hospital patients to dangerous bacterial contamination,” said U.S. Attorney Paul J. Fishman for the District of New Jersey.  “Today’s plea agreement and civil settlement require Pharmaceutical Innovations to accept responsibility for the contamination and take the necessary steps to prevent it from happening again.” 

Hospital Mobile Devices Improve Workflow, Pose Risks

As mobile devices become a more common tool for hospital settings, questions about leakage of confidential patient information arise. Mobile devices have been on the increase as hospitals realize the return on their investment by facilitating faster communication between nurses, doctors, and other hospital staff. However, cyber-security breaches are also a concern, as about one-quarter of breaches occur with mobile devices. While hospitals are not lessening the increased reliance on mobile devices as medical communication tools, continuing efforts to keep the highest level of security possible are expected.

New report details pre- and postnatal brain defects from Zika virus
Researchers from the epicenter of the current Zika virus outbreak have released a report on imaging findings in babies and fetuses infected with the Zika virus. Zika virus is most dangerous when transmitted from a pregnant mother to her fetus, increasing the likelihood of severe brain defects in the baby. In addition to microcephaly, the report identifies a wide array of brain defects, visible on CT, MRI and ultrasound. 
FDA approves first MRI-guided focused ultrasound device to treat essential tremor

The U.S. Food and Drug Administration today approved the first focused ultrasound device to treat essential tremor in patients who have not responded to medication. ExAblate Neuro uses magnetic resonance (MR) images taken during the procedure to deliver focused ultrasound to destroy brain tissue in a tiny area thought to be responsible for causing tremors.

“Patients with essential tremor who have not seen improvement with medication now have a new treatment option that could help them to avoid more invasive surgical treatments,” said Carlos Peña, Ph.D., M.S., director of the division of neurological and physical medicine devices in the FDA’s Center for Devices and Radiological Health. “As with other treatments for essential tremor, this new device is not a cure but could help patients enjoy a better quality of life.”

SonoSim, GE Healthcare re-up ultrasound training deal

Ultrasound education focused SonoSim said this week it is extending a collaboration with GE Healthcare (NYSE:GE)  to cover ultrasound training and education for GE’s women’s health and urology divisions.

Through the extended collaboration, Sonosim will offer its SonoSim 365 for GE Healthcare to clients in the women’s health and urology fields who own qualifying ultrasound systems with the goal of accelerating adoption of bedside ultrasound.