Boston Scientific's stroke-preventing Watchman was just hit by bad news on multiple fronts. The FDA revealed that the Watchman is the subject of two Class 2 recalls, while the Centers for Medicare & Medicaid Services has just deemed reimbursement of the device "not reasonable and necessary."
The fallout over Theranos' proprietary blood testing has cost it another partner amid growing pushback, as grocery store giant Safeway is severing its ties with the company after a $350 million deal fizzled out.
Quintiles has contributed open-source enhancements to Apple's ResearchKit, adding more sophisticated application features beyond the basic three modules first introduced by Apple in March. The CRO plans to develop patient engagement ResearchKit-based apps for use in its own clinical trials with a particular focus on neurodegenerative diseases including dementia.
As scientists search for lighter, low-cost alternatives to traditional imaging tools such as MRI or CT scans, engineers at Stanford University are developing a device that uses microwaves and ultrasound to pinpoint targets without touch, potentially improving tumor detection.
Apple CEO Tim Cook indicated that Apple is open to putting a product through the rigors of FDA review, but it will be a supplementary technology, not one of its mainstays like the Apple Watch.
Medtronic's leadless pacemaker performed well in a 725-person clinical trial for FDA approval in the U.S., where the bigwig is racing with St. Jude Medical to become the first to sell such a device.
The race is on to develop U.S. sources for a material necessary to create the most widely used radioisotope in medical diagnostic imaging. Now GE Healthcare and startup Shine Technologies have disclosed that they have successfully used GE's existing tech to create the common medical radioisotope technetium-99m (Tc‑99m) from molybdenum-99 (Mo-99) produced by Shine.
Royal Philips has explicitly made massive, multiyear hospital contracts part of its strategy as it works to define its leadership in HealthTech, the core of its corporate vision that's tied to its healthcare and consumer products. Now it's weighed in with a massive commitment on that front, a CA$300 million ($225 million) deal to provide an existing as well as a new hospital in Ontario with medical technology procurement, management and maintenance over the next 18 years.
IBM is teaming up with Boston Children's Hospital to use its Watson system for rare pediatric disease diagnosis and treatment, deepening its dive into healthcare as it signs on key biopharma partners to Watson and gets the ball rolling at its new global cloud computing hub in Cambridge.
Cardiovascular-focused Boston Scientific is moving deeper into oncology and expanding its vascular offerings with the purchase of the interventional radiology portfolio of CeloNova BioSciences. The deal with the San Antonio, TX-based startup involves a $70 million upfront payment with additional, undisclosed regulatory and sales milestones.
The FDA is cracking down on direct-to-consumer testing companies including DNA4Life and Interleukin Genetics for selling their tests without proper approval, a few weeks after the agency cleared the way for 23andMe to proceed with its DTC genetic reporting service.
St. Jude Medical touted a study in the journal The Lancet, which found that the company's CardioMEMS Heart Failure System for monitoring heart failure led to a 48% decrease in hospitalizations.
An analysis of registry data shows that medical community efforts to reduce the number of inappropriate stenting procedures have worked. Between 2010 and 2014, the rate of inappropriate nonacute percutaneous coronary interventions to implant stents has fallen from 26.2% to 13.3%, according to a paper in the Journal of the American Medical Association presented at the annual meeting of the American Heart Association.
Researchers are developing the world's first total-body positron emission tomography (PET) scanning device to improve disease diagnosis and treatment.
The U.S. Food and Drug Administration cleared the Flex Robotic System from Medrobotics in July. Now the startup has raised $25 million to launch the system for sale to U.S. hospitals. With its flexible scope, it's intended to provide an alternative to traditional line-of-sight approaches used to access and visualize the oropharynx, hypopharynx and larynx.
The Office of the Inspector General promised to put med tech reimbursement under the microscope during fiscal year 2016, citing Medicare costs associated with defective medical devices, cardiac catheterizations, imaging services and clinical labs as some of the device-world arenas worthy of particular scrutiny. Another area of focus will be medical device cybersecurity, according to the internal government watchdog's FY 2016 work plan.
Alphabet's Life Sciences group is broadening its med tech cachet through a new research deal with the American Heart Association (AHA), teaming up with the organization to come up with new tools and resources to address heart disease.
Functional Neuromodulation, a startup backed by Medtronic and the National Institutes of Health, will advance its deep brain stimulation implant into a Phase III trial to treat Alzheimer's disease patients. DBS is a standard treatment for movement disorders, such as Parkinson's disease, but hasn't been widely applied to other brain disorders.
Intersect ENT's stock plunged almost 25% after the maker of bioresorbable drug-eluting implants for conditions of the ear, nose and throat reported a loss of $9.7 million on sales of $14.2 million.
Israel's Intendu touted the launch of the Functional Brain Trainer to rehabilitate patients suffering from cognitive impairment using adaptive video games.