2breathe Technologies has taken an FDA-cleared device that's marketed to treat hypertension and adapted it to market a consumer device to address insomnia. Sleep was reported as a side effect with the original device, so company founders decided to create a device specifically to induce sleep.
Nevro was up 7% in early trading on news that it beat Wall Street expectations for first-quarter sales--and that it raised 2016 guidance. This is only the third full quarter that the company has reported sales since its Senza Spinal Cord Stimulation System to treat chronic pain was approved by the FDA last May.
Back in April 2015, Medtronic launched a clinical study of its Endurant Evo AAA stent graft system. Now, the company is pulling the plug on the trial after encountering a setback.
PureTech Health, a life sciences development company founded in part by Robert Langer, has announced a new startup, its second disclosed in as many days. This one, dubbed Alivio Therapeutics, will focus on using an innovative hydrogel to treat chronic and acute inflammation.
DePuy Orthopaedics has acquired a San Antonio, TX-based startup that stakes a claim to being the first U.S. manufacturer of Nitinol metal implants for musculoskeletal fixation. The company, BioMedical Enterprises, markets a slew of small bone fixation devices made of Nitinol that can change shape--a process that is controlled by temperature and that can provide continuous compression, which is thought to induce bone healing after fixation procedures.
Spinal surgeons are more apt to perform unnecessary surgeries if they make a profit off medical devices used in the procedures, according to a recent congressional study. Now, lawmakers who wrote the report are calling for a crackdown.
The FDA has cleared a low-pressure finger cuff that continuously monitors blood pressure beat-by-beat at an accuracy that exceeds the agency's requirement, according to its maker.
Intarcia has wrapped up data for the last of its four major pivotal trials for its implantable drug and delivery system to treat Type 2 diabetes. Known as ITCA 650, it combines a version of exenatide with a micropump to offer a GLP-1 agonist that can be implanted subcutaneously only once or twice yearly.
Patrick Soon-Shiong's big data cancer analytics player NantHealth is making a run again at an IPO after it was delayed by a whistleblower suit.
Scientists at the University of Pennsylvania are developing implantable electrodes for brain monitoring that melt away at a predetermined rate. The devices could come in handy for monitoring and treating certain neurophysiological disorders such as Parkinson's, depression and chronic pain.
St. Jude Medical presented data on its leadless pacemaker and cited two other presentations given at this year's Heart Rhythm Society gathering that demonstrated the Nanostim device can be successfully retrieved from patients without serious adverse complications.
As the Zika epidemic rages on, scientists are looking for new diagnostics that can quickly and inexpensively monitor outbreaks. Now researchers at Harvard's Wyss Institute for Biologically Inspired Engineering are developing a low-cost test that uses small paper discs to rapidly pinpoint the virus.
Major medical device makers--and hospitals themselves--are busily rolling out 3-D printed medical devices and products. But now a major player in the effort has called for a bit of a timeout to agree on a common standard for the clinical, economical and patient outcomes of medical 3-D printing.
Medtronic has presented data on its leadless pacemaker, Micra, showing consistent safety and efficacy at months after implant--even under extreme conditions. Micra was just approved by the FDA last month and is the first leadless, transcatheter pacemaker to be approved in the U.S.
Medical device makers, not hospitals, will get squeezed in the coming years as the Centers for Medicare and Medicaid (CMS) implements its value-based pricing scheme for hip and knee implant procedures. This is the first mandatory bundled payment initiative from the U.S. agency, although it previously has piloted bundled payment programs and value-based reimbursement such as penalties for hospitals with above-average patient readmissions.
Researchers at the University of California-Davis report that glasses fitted with a miniature camera that uses optical character-recognition technology could help people who qualify as legally blind to read again.
Interventional oncology specialist BTG is working to make med tech more relevant in oncology--something it's got a shot at doing as localized treatment delivery and minimally invasive surgical techniques continue to emerge.
Taiwan's ACT Genomics roped in $12.5 million in Series B funding to spur development of its cancer tests and to chart growth in Asia's fast-growing diagnostics market.
Royal Philips has installed the first spectral detector-based computed tomography (CT) system at the University Medical Center Utrecht.
AliveCor brought on a former Google exec last year to run the company. Now, it may be on the path to the data it needs to make its smartphone-based ECG recorder the standard-of-care for patients with undiagnosed heart palpitations.