News

ArthroCare $750M fraud saga culminates in decades-long prison term

Cooking the books doesn't pay. That's the message the U.S. Department of Justice sent with the strict sentence it got for ArthroCare executives—albeit almost a decade after the problematic bookkeeping practices began.

St. Jude emphasizes cardiology guidewires, technology for fractional flow reserve

St. Jude Medical's data dump at the European Society of Cardiology Congress in Barcelona, Spain, was heartening news for the company's products--especially those used to measure a ratio known as fractional flow reserve.

Medical device excise tax repeal remains a top Republican priority

A plan to repeal the medical device tax enacted in 2010 might be in the works among Republican senators gearing up for the expected GOP majority in Congress.

Boston Scientific faces stinging setback for vagus nerve stimulation device in mid-stage trial

Boston Scientific is facing a stinging setback in the highly competitive neuromodulation field as the company's vagus nerve stimulation (VNS) device failed to improve cardiac function in a recent mid-stage clinical trial.

Dime-sized device can separate healthy and cancerous cells

MIT scientists have developed a dime-sized microfluidic device that can sort rare cancer cells from healthy ones using sound waves--an innovation that could have applications for cancer diagnosis, drug discovery and clinical research.

Can the nose bone be connected to the knee bone?

Researchers at the University and University Hospital of Basel in Switzerland report they have taken cartilage cells from nasal septums and successfully generated new cartilage that was used to repair damaged knees in patients.

Attorney: Latest UDI guidance unhelpful, many questions left unanswered

The latest in a series of guidances explaining and implementing last year's Unique Device Identification final rule is "little more than a regurgitation of information contained in the rule itself, the preamble to the rule, the UDI website, and the Global Unique Device Identification (GUDID) guidance document," wrote medical device law attorney Jennifer Newberger.

Transcranial magnetic stimulation can improve memory, study shows

Researchers used transcranial magnetic stimulation to stimulate the hippocampus region in the brain. This resulted in increased connectivity in related regions and improved memory that persisted in healthy volunteers for more than 24 hours after stimulation, according to a study in the latest issue of the journal Science.

J&J looks to sell off Cordis for as much as $2B

Johnson & Johnson is reportedly seeking a buyer for its Cordis unit, which is focused on vascular medical devices. This would be the second major divestiture for the conglomerate this year, it sold Ortho-Clinical Diagnostics to private equity firm The Carlyle Group in June for $4.2 billion.

FDA clearance of Medtronic's scoliosis implant a much-needed victory for pediatric devices

Pediatric devices are in short supply because of the prevalence of rare diseases in children, as well as their unique physiology. So, FDA's 510(k) clearance of Medtronic's Shillla Growth Guidance System for the treatment of scoliosis in children less than 10 years old has particular significance.

Bayer's startup accelerator funds 5 device, healthcare app companies

Fresh off the sales of its interventional device unit to Boston Scientific, Bayer Healthcare is showing renewed interest in med tech via its startup accelerator.

New imaging system uses biomarker to guide brain cancer surgery

Brain surgeons have long relied on a pathology analysis to determine if they have completely removed a tumor. This can be a time-consuming and inaccurate process. Results of a study for a new imaging system that detects a molecular marker found in brain gliomas suggest it could improve upon that surgical practice.

Covidien acquires Sapheon ahead of FDA approval for vein adhesive

The Medtronic-Covidien integration team must be working overtime juggling not only existing products but also those in the deal pipeline. The pair hasn't slowed down at all--between them they have disclosed 5 acquisitions since their own merger announcement in mid-June, three of them this week alone.

Medtronic launches clinical trial of AdaptivCRT physiologic pacing algorithm

Medtronic announced an international clinical trial comparing standard cardiac resynchronization therapy against CRT with the AdaptivCRT physiologic pacing algorithm that makes automatic adjustments to the therapy.

ReShape targets U.S. approval as EU study shows major weight loss

ReShape Medical revealed the first postapproval data from the EU for its nonsurgical, balloon-based weight-loss system: 42% of excess weight loss on average with a variance of 23%. But the company cautions that because of the different way the trials are designed, it won't have similar results when it releases pivotal U.S. trial data in November.

White House spotlights need for electrical implants to treat inflammatory and neurological diseases

President Obama highlighted a $78.9 million BRAIN Initiative project to improve service members' and veterans' health through the development of nano-scale electrical implants to modulate nerve signaling and record health biomarkers.

J&J's DePuy Synthes unit slapped with FDA Class I recall for jaw-stabilizing device

Johnson & Johnson's DePuy Synthes unit is facing regulators' ire as the FDA slapped the company's recall of its jaw-stabilizing device with a Class I label, its most serious designation.

Biomarker could improve early rheumatoid arthritis diagnosis

A novel biomarker could make it easier for physicians to diagnose rheumatoid arthritis early, thereby improving patients' prospects. The best results come when conventional antibody testing is combined with the new biomarker.

Medtronic expands hospital services push with $350M acquisition

Medtronic  wants to be known for manufacturing high-quality devices and providing related services as well. To that end, the company today announced the acquisition of privately held Italian company NGC Medical S.p.A.

Med tech IPOs for NeuroSigma, ReWalk ready for fall

Epilepsy devicemaker NeuroSigma filed to raise up to $50 million in an IPO, while ReWalk--whose mobile exoskeletons were recently approved by the FDA--set IPO terms to raise $50 million.