Olympus and Sony are rolling out a high-definition endoscope, months after Sony--Olympus' largest shareholder--announced that it would sell off half its stake in the company amid growing scrutiny over Olympus' duodenoscope devices.
Royal Philips aims to roll out a series of programs for chronic diseases that marry consumer-oriented device data with the electronic medical record. The idea is to give patients and healthcare providers access to all the relevant data and analysis to improve self-care and medical care.
Thoratec said that two patients died and one suffered a serious injury after they were unable to connect their HeartMate II left ventricular assist device to their backup system controller in a timely manner.
Valtech gets CE mark for transcatheter mitral valve repair device, validating HeartWare's looming $929M takeover
Israel's Valtech Cardio has secured a CE mark for its transcatheter mitral valve repair device, in a win for HeartWare, which is acquiring the company for about $929 million in a bid to enter the burgeoning transcatheter mitral valve repair and replacement space.
St. Jude Medical announced the new executive team that will serve under incoming CEO Michael Rousseau, beginning Jan. 1, 2016.
The National Institutes of Health called an early halt for an enormous, 9,300+ person trial examining the role of blood pressure intervention due to significant preliminary results. The U.S. agency found that maintaining systolic blood pressure at a lower level than current recommendations reduces rates of heart disease and the risk of death.
Qualcomm Life is reaching further into healthcare and the hospital with its purchase of Capsule Technologie, thereby extending its existing focus on at-home healthcare products.
Infection prevention and control player Cantel Medical will purchase U.K. startup Medical Innovations Group for $79.5 million in cash. The acquisition adds a recently launched endoscope storage system as well as single-use endoscopy consumables, mobile cart systems and patient transport products.
UPDATED: FDA begs manufacturers to participate in global single audit pilot, says next stage may not be voluntary
The international Medical Device Single Audit Program to coordinate manufacturing facility inspections across 5 countries is not securing much participation from industry, much to the chagrin of the FDA. Only 45 manufacturing sites expressed interest in joining the program in its first year, out of a goal of 330 sites by the end of 2016.
Global venture capital firm New Enterprise Associates has hired Dr. Stephen Oesterle as one of its partners from Medtronic, where he was executive vice president.
Jefferies equity analyst Raj Denhoy upgraded their revenue projections for St. Jude Medical's CardioMEMS Heart Failure Monitor from $140 million to $172 million in 2016 following a survey of 38 cardiologists, which found good satisfaction levels and decent uptake, but said so-so reimbursement and a high administrative burden were inhibiting wholesale adoption.
The U.S. Biomedical Advanced Research and Development Authority (BARDA) expects that startup Velico Medical could play a role in securing the nation's blood supply. It's working to develop a technology that could be used by regional blood centers to create dried plasma and platelet products that could be rehydrated to offer an alternative to frozen versions.
Infraredx will be acquired by its Japanese partner and investor Nipro. The pair had an exclusive 5-year distribution deal in Japan for the company to sell the startup's cardiac imaging system. Nipro has already gained Japanese approval for the NIRS-IVUS True Vessel Characterization Imaging System from Infraredx to find cholesterol-rich, lipid core coronary plaques that are thought to precipitate heart attack.
A California WARN notice shows that 279 employees will be axed at the end of October due to the impending closure of Zimmer's Carlsbad, CA, dental headquarters, which has manufacturing and distribution functions.
The SEC cracked down on John McEnery III, his son, John McEnery IV, and Michael Rawitser for allegedly committing insider trading in relation to GE's acquisition of cancer diagnostic and laboratory services company Clarient in October 2010.
The FDA has been getting it from all sides lately for its oversight of power morcellator devices, with lawmakers last month urging the U.S. Government Accountability Office (GAO) to probe the agency's regulation of the products. Now, the GAO is planning to take on the charge and launch an investigation into the devices.
IBM's Jeopardy-winning Watson had a busy day thanks to the opening of the new IBM Watson Health global HQ in Cambridge, MA. As is often the case, the ribbon cutting was accompanied by a plethora of newly announced customers and boasts about new capabilities.
Engineering professor Beth Kolko is on a mission to sell low-cost devices. She's dismayed at the current landscape, which favors high-cost devices because cheaper alternatives can't support the sales forces needed to sell them, according to one industry exec.
Proteus Digital Health and partner Otsuka have submitted an application to the FDA for approval of their innovative drug adherence device, a milestone for Proteus months after scoring the agency's clearance for its sensor product.