Device Studies

Latest Headlines

Latest Headlines

AliveCor smartphone ECG as good as standard Holter monitor: Study

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.

UPDATED: FDA rejects Otsuka, Proteus pill with medication adherence monitoring

The first U.S. regulatory test for a drug that incorporates medication adherence technology has been met with a rejection. The Food and Drug Administration issued a complete response letter to Otsuka Pharmaceutical and Proteus Digital Health for their drug/device combination of Abilify with Proteus' ingestible sensor.

Medtronic's tiny cardiac monitor shows improved afib detection in real-world study

Two years ago, Medtronic rolled out its Reveal Linq, a tiny implantable cardiac monitor, with annual sales predictions to the tune of $1 billion to $2 billion. Now, the company is reporting one-year data from a real-world study of the device showing that it was better at detecting atrial fibrillation than previously thought.

Brain implant, electrode sleeve reanimate quadriplegic's fingers

For the first time, a quadriplegic was able to move his fingers and hand with his own thoughts, using technology that allows brain signals to circumvent his injured spine and go directly to his muscles.

Harvard team uses bacterial enzyme coating to extend life of implantable devices

The body's response to foreign material--forming blood clots and becoming inflamed--can prevent blood-contacting implants like stents and heart valves from working properly. While the only recourse is to replace the device, Harvard scientists have developed a new biochemical method to coat these devices to preserve their function.

Senator grills Medtronic, FDA over alleged mishandling of Infuse bone graft study data

Medtronic has taken some responsibility for mishandling data from a retrospective chart review of its bone graft, Infuse, after a recent report said that the company allegedly buried side effect reports linked to the product. But Medtronic's response did not appease one lawmaker, who is calling on the company and regulators for more answers.

UPDATED: Medtronic shut down study of Infuse bone graft and tucked away the evidence: Report

Medtronic is coming under fire for shutting down a study of its bone graft, Infuse, and allegedly tucking away the data. A recent report from The Minneapolis Star Tribune said that the company uncovered serious problems linked to the product but didn't immediately tell anyone, which sparked pushback from the government and the public.

Medtronic artificial pancreas may hit the market next spring, as pivotal trial nears final data

An artificial pancreas, a device that automatically regulates insulin dosage for Type 1 diabetes patients based on real-time glucose data, may be a reality soon. Medtronic is nearing final data for a pivotal trial of its Hybrid Closed Loop System. It reportedly expects to submit to FDA for approval by the end of June, with an anticipated launch by April 2017.

Proteus unveils outcomes data to demonstrate medication adherence benefits to payers

Patient compliance with long-term drug regimens is notoriously poor--particularly in populations with chronic conditions that require consistent, routine care in order to avoid disease progression. Technology to improve patients taking their medications now abounds, everything from smart inhalers to digital pills to apps promise to offer improvements.

St. Jude touts favorable outcomes study of CardioMEMS heart failure monitor

St. Jude Medical touted an independent study from a New York healthcare system during the annual meeting of the American College of Cardiology, which showed patients who were implanted with the company's CardioMEMS patient monitoring cardiology implant experienced a plethora of benefits.