Today, the U.S. Food and Drug Administration cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU). “Although we can use traditional MRI scanners to image neonates, taking babies outside of the neonatal intensive care unit to MRI suites presents great challenges,” said Vasum Peiris, M.D., M.P.H., chief medical …

ClearFlow, Inc. has announced a full market release for the 20Fr SEDL version of the PleuraFlow® Active Clearance Technology® System for the treatment of pediatric cardiothoracic surgery patients. The SEDL refers to the “shorter effective drainage length,” which facilitates placement of the PleuraFlow chest tube in the smaller chests of pediatric patients. ClearFlow received clearance from the United States Food …

Cello Health has announced the acquisition of the US company Advantage Healthcare Inc. (‘Advantage Healthcare’). Advantage Healthcare was founded in 1994 by Deborah K. Glick and today operates from offices in Princeton and Midland Park, New Jersey, and New York City. The company provides critical analyses and insights in biopharmaceuticals to inform activities primarily in new products. These include commercial …

Varian Medical Systems has received FDA 510(k) clearance for its Halcyon™ system, its new device for cancer treatment. Halcyon simplifies and enhances virtually every aspect of image-guided volumetric intensity modulated radiotherapy (IMRT). “We are proud that Halcyon has now received both 510(k) clearance and CE mark,” said Kolleen Kennedy, president of Varian’s Oncology Systems business. “With its human-centered and user-friendly …

Kindred Healthcare announced the signing of a definitive agreement to create a partnership to construct and operate a 34-bed inpatient rehabilitation hospital in Billings, Montana. The new inpatient rehabilitation hospital, The Rehabilitation Hospital of Montana, will offer all private rooms and treat patients who are recovering from conditions such as stroke, traumatic brain injury and spinal cord injury. The hospital …

DePuy Synthes Products announced that it has acquired Innovative Surgical Solutions, LLC, doing business as Sentio, LLC, a privately-held company based in Wixom, Michigan that markets innovative nerve localization technology for spine surgery. This acquisition underscores the DePuy Synthes and Johnson & Johnson Medical Device Companies strategy of investing in faster growing segments with technologies that are designed to help …

Channel Medsystems, announced that it has earned CE Mark approval, allowing the Company to initiate marketing efforts and commercialization of its Cerene Cryotherapy Device (Cerene device) in Europe.  The Cerene device is intended for endometrial cryoablation in premenopausal women with heavy menstrual bleeding due to benign causes in whom childbearing is complete. Current endometrial ablation procedures can be painful and …

Cerveau Technologies Inc. announced a research collaboration with the NYU Langone Medical Center to support various research projects studying the stages of Alzheimer’s Disease and other Neurodegenerative diseases. These research projects will utilize an investigational imaging agent (MK-6240) to be used in Positron Emission Tomography (PET) scans for assessing the status and progression of neurofibrillary tangles (NFTs) in the brain. …

Paragon 28 launches the PHANTOM™ Lapidus Intramedullary Nail, the first dedicated intramedullary nail designed specifically for use in correction of arthrodesis of the first TMT joint. Surgeons face a variety of challenges and complications in bunion correction with a Lapidus procedure: •  Prominence of hardware creating patient discomfort •  Generation and maintenance of compression at fusion site to allow for proper healing …

Merck, known as MSD outside the United States and Canada, and Premier Inc., a leading healthcare improvement company, have expanded their efforts to co-develop and test solutions to help improve patient care and wellness while lowering healthcare spending. In 2016, Merck and Premier agreed to collaborate to develop and assess solutions that promote wellness and better care for specific groups …