A deal has been reached by Johnson & Johnson and the University of Pennsylvania to establish JPOD @ Philadelphia at the university's startup incubator to support local startups in medical devices, consumer and health technologies, and pharmaceuticals. The partnership comes as part of J&J's JLABS initiative, which will initiate the JPOD @ Philadelphia QuickFire Challenge to provide funding for accelerating innovations.
A Transparency Market Research report predicts the worldwide market for small bone and joint orthopedic devices will hit $8.2 billion by 2023 with a compound annual growth rate of 8.1%. Among the key players in the market, which is led by the fracture fixation and replacement systems segment, are DJO Global, DePuy Synthes, Stryker, Wright Medical, Arthrex, Smith & Nephew and Zimmer Biomet.
A US clinical study has been initiated by Medtronic to assess diagnostic use of its ECG belt research system for supporting cardiac resynchronization therapy decision-making in patients with heart failure. The 400-patient, 10-site trial will compare use of the system and CRT with standard CRT alone.
Mirada Medical has secured clearance from the FDA to market its DLCExpert deep-learning contouring software for radiation oncology treatment planning as part of the company's Workflow Box 2.0 Zero-Click platform. The artificial intelligence software facilitates time-saving delineation of tumors and other structures on patients' CT scans, the company said.
The House Ways and Means Committee's Subcommittee on Health this week held a hearing to discuss possible changes to the Stark Law, which bars self-referrals for medical care, to ensure the law does not interfere with the creation of accountable care organizations. "[AdvaMed commends] the leadership of the subcommittee for exploring ways to modernize the Stark Law as the US health care system continues its transition from a fee-for-service model to one that better promotes value-based health care," said AdvaMed President and CEO Scott Whitaker.
Janssen's Intelence, or etravrine, was approved by the FDA for use in patients with HIV ages 2 to 6 who weigh a minimum of 10 kg. The drug was previously approved for patients at least 6 years old.
Novartis' Kisqali, or ribociclib, was approved for expanded use by the FDA as a treatment for pre/perimenopausal or postmenopausal women patients with HR+/HER2- advanced or metastatic breast cancer as initial endocrine-based therapy. The agency also approved the drug in combination with AstraZeneca's Faslodex, or fulvestrant, in postmenopausal women with the disease as an initial endocrine-based therapy or after disease progression on endocrine therapy.
Genentech's Tecentriq, or atezolizumab, in combination with Avastin, or bevacizumab, was granted the FDA's breakthrough therapy designation. The combination is being developed to treat patients with advanced or metastatic hepatocellular carcinoma.
Zavation has obtained 510(k) clearance from the FDA for its Normandy vertebral body replacement system, which is indicated for reconstruction following vertebral body and disc removal or for use in the thoracolumbar and cervical spine for vertebral body replacement due to osteomyelitis, tumor or trauma. The device is designed to provide skeletally mature patients with structural stability.