News

Study: Researchers find dual-hormone artificial pancreas best for treating nocturnal hypoglycemia

Canadian researchers have found that the dual-hormone artificial pancreas works best for treating patients with Type 1 diabetes by reducing the amount of time they are exposed to nocturnal hypoglycemia.

North Dakota State University team prototyping leadless, batteryless pacemaker

A dual-chambered leadless pacer would earn billions in revenue and overtake the entire market, but has proven elusive due to technical challenges. A North Dakota State University team has another idea for improvement.

Indian feds stake out plan to become a global hub of device manufacturing and innovation

India plans a federal National Medical Device Authority to promote its nascent med tech sector through such industry-friendly measures as the creation of industrial parks, tax concessions and direct government funding of startups. But price controls and preferential treatment of domestically manufacturing devices are also part of the plan, to the concern of industry bigwigs, who are largely based in the U.S.

Micro-cap TransEnterix raises $50M ahead of FDA review for laparoscopic surgery robot

Investors pushed shares of surgical robotics player TransEnterix down 4% to the offering price as the company sold 16.7 million shares at $3 each to raise $50 million. The move is intended to raise enough cash to see it through a launch for its SurgiBot laparoscopic surgery platform, which it submitted to the FDA on June 1.

Philips cautions on cardio mortality after ResMed sleep apnea data, intros cardiac imaging tool

Royal Philips said it is working with ResMed to analyze study data from mid-May showing that the latter company's Adaptive Servo-Ventilation central sleep apnea treatment worsens cardiovascular mortality for those in a particular subset of chronic heart failure data. Philips has a similar device, which it said is contraindicated in the relevant population with increased mortality: moderate to severe central sleep apnea patients with symptomatic chronic heart failure and left ventricular ejection fraction of less than or equal to 45%.

Boston Scientific touts improved spinal cord stimulator at neuromodulation conference

Boston Scientific promoted new information that its latest spinal cord stimulator is twice as effective as its predecessor at lower back pain relief at the International Neuromodulation Society 12th World Congress in Montreal.

Augmenix unleashes promising data for injectable prostate cancer spacer

Augmenix is trumpeting results from a study of its prostate cancer spacing device, promising data as the company charges ahead with development for the product after snagging FDA clearance in April.

Medtronic launches Covidien's peripheral balloon catheter in the U.S.

Medtronic announced the U.S. launch of its Fortrex balloon catheter, which performs angioplasty to physically disrupt blockages so that vessels can accept therapy via an arteriovenous access point.

Smith & Nephew to shutter 20+-year-old site in U.K.

Orthopedics company Smith & Nephew plans to close its York, U.K., facility by the end of 2016, resulting in the relocation of 80 jobs.

FDA announces Class 1 recall of Zimmer, HeartWare and Maquet devices

The FDA added three Class 1 recalls to its database this week, reserved for situations in which the agency believes exposure to the faulty device "will cause serious adverse health consequences or death."

FDA slaps Insulet with warning letter over insulin pumps

Insulet has long struggled with manufacturing issues tied to its insulin pumps and battled it out with a couple of device heavyweights over proprietary pump technology. Now, the FDA is slapping the devicemaker with a warning letter for some of its insulin pumps after finding a few issues at its facility earlier this year.

U.K. to fund camera-based patient monitoring prototype development after initial study

Innovate U.K., the country's agency designed to foster technology advances, will fund the development of a prototype for a camera-based, remote patient monitoring system from Oxehealth that's ready to be deployed in real-life settings. This comes just as the startup reports positive results from a proof-of-concept study that was also funded in part by the same agency.

Hospira execs called 'shameful' for denying cybersecurity risks posed by their infusion pumps

It's been more than a year since cybersecurity guru Billy Rios flagged Hospira's PCA 3 Lifecare infusion pumps for its poor cybersecurity. The issues have gone unaddressed, Rios says in a critical blog post, writing "we have yet to see a single fix for the issues affecting the PCA 3."

J&J details a slew of early R&D partnerships--including at least 5 in med tech

Johnson & Johnson has hit a milestone--with more than 200 collaborations formed through its Johnson & Johnson Innovation that was launched in 2013. The latest crop of 17 new collaborations with research institutions and healthcare companies brings with it at least 5 that clearly could help advance the state of med tech.

China-U.S. bridging investor Ally Bridge Group discloses 6 recent med tech investments

A typically biopharma-focused investor that bridges from China to global healthcare, Ally Bridge Group (ABG), has announced it's made 6 recent med tech investments. These are in addition to another recent, high-profile deal: the $3.3 billion proposed take-private offer for contract research organization WuXi PharmaTech, in which ABG is also a potential investor.

Researchers develop injectable electronic mesh as brain implant to treat stroke, Parkinson's patients

Researchers have developed a soft, conductive electronic polymer mesh that can be injected into the brain to monitor and stimulate it at the level of individual neurons. They have published preclinical data on the device in the latest issue of Nature Nanotechnology.

Finnish headset light therapy via the ear canal cut jet lag time in half in study

Researchers from Finland worked with startup Valkee to unveil a bright light headset to treat seasonal affective disorder in 2010. Now it's released placebo-controlled, randomized data about jet lag reduction for its CE-marked headset dubbed the HumanCharger.

Lawsuits against Medtronic executives over Infuse bone graft dismissed

Medtronic said in a regulatory filing that three shareholder lawsuits against current and former executives were voluntarily dismissed.

Biotronik vascular stent determined effective in challenging cases of peripheral artery disease

Germany's Biotronik touted a recent study of its CE-marked Pulsar-18 stent for peripheral artery disease, saying the data showed the device can be used in challenging cases of the condition.

UPDATED: Bard, Medtronic get additional CMS reimbursement for their drug-coated balloons

C.R. Bard announced that the federal Centers for Medicare & Medicaid Services further improved reimbursement for its recently launched Lutonix drug-coated balloon for peripheral artery disease in the femoropopliteal arteries (located near the knee).