Digital medicine startup Appliedvr Inc. has gained breakthrough device designation status from the U.S. FDA for its virtual reality (VR) platform for treating treatment-resistant fibromyalgia and chronic intractable lower back pain. The designation follows the completion of a clinical trial assessing VR-based therapy for self-management of chronic pain at home.

While the FDA’s approach to evaluating safety and efficacy in the development and review of COVID-19 vaccines for the U.S. market will be at the center of its Oct. 22 advisory committee meeting, the panel also will be asked to discuss the practicalities, and ethics, of continuing to conduct trials once a candidate has been granted an emergency use authorization.

Royal Philips NV is launching its Quickclear mechanical thrombectomy system in the U.S. four months after obtaining FDA clearance. “Quickclear's intuitive design simplifies the entire thrombectomy procedure work flow. Our new medical device can help bring cost-effective solutions in both the hospital and outpatient care settings,” Chris Landon, senior vice president & business leader, image guided therapy devices at Philips, told BioWorld.

Thermo Fisher Scientific Inc. launched a new cell therapy processing system that overcomes many of the hurdles that have kept promising cell therapies from reaching commercialization. The modular, closed system increases cell processing efficiency and reduces associated costs.

Spectrawave Inc. has named Eman Namati as its CEO with the charge of commercializing its flagship cardiac imaging technology. The 3-year-old, Bedford, Mass.-based medical imaging company has set an ambitious 24-month timeline for getting its photonic imaging technology for coronary artery disease into the clinic.

The case of Arthrex v. Smith & Nephew at the U.S. Court of Appeals for the Federal Circuit was something of a nuclear option for the patent dispute at hand, as it raised a constitutional question regarding the appointment of administrative patent judges (APJ) at the Patent Trial and Appeal Board (PTAB). The Supreme Court has agreed to hear a consolidation of three petitions for cert arising from the Arthrex case, the outcome of which could force the reopening of a number of cases already decided by the PTAB.

Intervenn Biosciences said it has identified stark differences in the glycoproteomic profile of COVID-19 patients who became very sick and people infected with the SARS-CoV-2 virus who were either asymptomatic or experienced only minimal effects. The contrast could help clinicians better understand the biological mechanisms of the disease and triage patients at risk of responding detrimentally to early treatments and more intensive care.

Two teams of researchers have developed miniature models of the human heart that beat and function like the full-size organ. The team from Michigan State University (MSU) and Washington University in St. Louis developed a human heart organoid (hHO) that recapitulates embryonic heart development, providing an unmatched view into congenital heart defects. The organoid created by the researchers at the Medical University of South Carolina (MUSC) and Clemson University mimics the tissue dysfunction that occurs following a heart attack.

Time is of the essence when treating patients with advanced or metastatic cancer, and diagnostic insights can inform treatment plans. To that end, Exact Sciences Corp. has launched its Oncotype MAP Pan-Cancer Tissue test for patients with advanced, metastatic, refractory or recurrent cancer. From a small tissue sample, the test detects genomic alterations in hundreds of cancer-related genes, helping doctors better depict a patient’s tumor and recommend effective therapies or clinical trials.

COVID-19 stalled clinical trials, halted elective surgeries, and body slammed many med-tech companies’ revenues. Despite that, an industry report released by Ernst & Young (EY) finds that the pandemic also drove some positive changes in the med-tech industry including long-neglected attention to enterprise-wide business continuity.