Digital Transformation

This evolution of healthcare involves using technology to improve diagnosis, treatments, monitor patients, enhance hospital operations and culture, and bolster consumer-focused care. This includes virtual reality tools, wearable devices, workflow software, health apps and other digital health tools.

FDA approves first umbilical-cord blood product

The FDA has given its first green light to a stem-cell transplantation product using umbilical-cord blood. Hemacord, produced by the New York Blood Center, is intended to treat patients with disorders affecting the blood- forming system, such as certain blood cancers and inherited metabolic and immune system disorders.

TCT: Platelet function testing is still not ready for prime time

The large-scale ADAPT-DES registry, which assessed platelet reactivity with a variety of platelet function tests in more than 8,500 patients, reaffirmed that the tests have not found an appropriate place in routine clinical practice. The study was presented Nov. 9 at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) conference.

Barco unveils video-over-IP system

Barco, the healthcare imaging company based in Kortrijk, Belgium, will unveil Nexxis, an uncompressed video-over-IP system for image distribution in the operating room, at the MEDICA trade fair in Dsseldorf, Germany, Nov. 16 19.

Bipartisan caucus calls for faster medical device reviews

The bipartisan, bicameral Congressional Medical Technology Caucus raised concerns over the FDAs medical device approval process in a letter sent to the agency early this month. The legislators suggested that slow approval times for medical devices may lead to the displacement of the U.S. as the leader in developing medical technology. They also stated that the industry indirectly creates two million American jobs.

Mizuho recalls OSI Modular Table Systems

Due to reports of patient injuries related to the Mizuho OSI Modular Table Systems, the FDA notified healthcare professionals of a Class I recall of the product. The systems are used for patient positioning during orthopedic trauma, thoracic and spinal surgery procedures.

$5.3B medical bed market to grow outside of U.S., EU

Medical bed markets outside of the U.S. and Europe will experience larger growth than traditional markets in coming years, according to market research firm Kalorama Information. While traditional markets will grow, countries with developing healthcare markets will experience stronger growth in the $5.3 billion medical bed market.

FDA clears low-pressure HSG device

Womens medical device developer Femasys has received FDA 510(k) clearance to market its FemChec Pressure Management Device, designed for a low-pressure HSG test.

Report: Europe no panacea for struggling U.S. health IT vendors

Discouraged by ebbing new-product sales at home, U.S. vendors of health IT have invested millions to build customer bases in Europeonly to find the going just as slow.

Around the web

The American College of Cardiology has shared its perspective on new CMS payment policies, highlighting revenue concerns while providing key details for cardiologists and other cardiology professionals. 

As debate simmers over how best to regulate AI, experts continue to offer guidance on where to start, how to proceed and what to emphasize. A new resource models its recommendations on what its authors call the “SETO Loop.”

FDA Commissioner Robert Califf, MD, said the clinical community needs to combat health misinformation at a grassroots level. He warned that patients are immersed in a "sea of misinformation without a compass."

Trimed Popup
Trimed Popup