News

Svelte Medical raises $16M for smaller drug-eluting coronary stent

Svelte Medical is trying to slenderize the coronary stent. It's raised $16 million to help get to market with its transradial cardiac stent. It has a smaller profile that makes it less invasive and allows it to be inserted via an artery in the wrist rather than the traditional route via the groin.

 

Jury clears former NFL player and co-CEO of fraudulent devicemaker on most serious charges

A jury just cleared a retired, Super Bowl winning wide receiver of charges of fraud related to a plan to pump up the stock of Heart Tronics, a cardiology device company.

Canon BioMedical makes first move with rapid DNA, drug metabolism diagnostic startup

Canon U.S.A. just announced its BioMedical subsidiary earlier this month. Now it's made its first med tech deal, an investment in Canadian diagnostic startup Spartan Bioscience, offering a glimpse of what to expect in the future from this new direction for the digital imaging company.

Boston Scientific subsidiary hit with $50M gender discrimination suit

A California-based Boston Scientific company was slapped with a $50 million gender discrimination suit from a former manager and a current executive who claim the devicemaker unfairly favors its male employees by paying them higher salaries and assigning them to more profitable territories.

Medtronic's stent for peripheral artery disease wins expanded indication from FDA

After staving off Treasury Department rules, angry politicians and antitrust regulators, Medtronic is earning early victories from its $50 billion mega-acquisition of Covidien. The company announced that the former rival's Protégé GPS peripheral stent for treating peripheral artery disease now has the FDA's blessing to be used against lesions in the common and external iliac arteries, located in the pelvis.

FDA will discuss challenges and opportunities of robotic surgery at public meeting this summer

The FDA is putting robot assisted surgery in the spotlight this summer. 

New indoor color-blindness-correcting glasses launched

EnChroma launched a new, indoor version of its color-blindness-correcting glasses for those suffering from red-green color blindness.

Micro-cap Bovie Medical raises $10.6M to back plasma-based surgical tool

Shares of Bovie Medical skidded a further 2% on news that the company had raised about $10.6 million in a follow-on offering. That's an impressive feat given that its market cap is a scant $44 million.

UPDATED: Medtronic steerable sheath recalled, deemed potentially deadly by the FDA

The FDA just labeled the recall of Medtronic's 10 French FlexCath Select Steerable Sheath as a class I recall. This means there is a reasonable probability that the device "will cause serious adverse health consequences or death.

American College of Cardiology meeting supportive of ablation to treat warning sign of stroke

In a win for cardiac ablation device makers like Johnson & Johnson's Biosense Webster and AtriCure, two studies presented at the American College of Cardiology's annual meeting in San Diego concluded that performing atrial fibrillation ablation improves outcomes.

Diabetes research advocacy groups call for better insulin pump regulation

The American Diabetes Association and the European Association for the Study of Diabetes have published a statement calling for the adoption of improved and harmonized safety standards for insulin pumps.

Vivo Capital doubles down to close $750M U.S.-China healthcare fund

Vivo Capital has closed an oversubscribed eighth fund at $750 million to invest in later-stage pharma and medical device companies in the U.S. and revenue-stage companies in greater China. That's precisely twice the size of its prior fund, which closed at $375 million in January 2012.

Olympus faces more legal pushback over endoscopes linked to UCLA superbug outbreak

Olympus was slapped with two new lawsuits over endoscope devices tied to a recent superbug outbreak at UCLA, adding to a mounting heap of litigation from patients and families affected by the devices.

Boston Scientific implantable defibrillator gets FDA green light

Boston Scientific announced that it has received FDA and CE-mark approval to launch the next generation of its subcutaneous implantable defibrillator system, which is implanted under the skin and does not have wires that come into contact with the heart.

Berkeley, UCSF researchers develop smart bandage to prevent and monitor bedsores

Engineers have created a smart bandage to detect and assess tissue damage from pressure ulcers before it can be seen by human eyes. This early detection could make recovery easier and more possible; the technology could also be used to monitor an existing bedsore.

Sen. Warren responds to CMS' opposition to UDI, says she expects agency to resolve issues

FierceMedicalDevices has obtained a copy of the letter in which the former administrator of the Centers for Medicare & Medicaid Services, Marilyn Tavenner, voiced her opposition to including unique device identification data in health insurance claims forms, to the chagrin of patient advocates and the FDA.

Teleflex says its new tool for laparoscopic surgery will help minimally invasive approach gain traction

Teleflex announced that its FDA-cleared minimally invasive surgical system for laparoscopic surgery is officially in use. The device was just used for the first time at the Cleveland Clinic, though as a part of an evaluation of the tool.

Tablets, apps being deployed to improve customer service in the ICU

Hospitals across the country are deploying apps and health information technology to the intensive care unit with a goal of humanizing healthcare and improving interactions with patients and their families.

Mayo Clinic finds a common MRI contrast agent is deposited in the brain

The Mayo Clinic has found that gadolinium-based contrast agents used in MRI exams leave deposits in the brain. The researchers said that there is no evidence that the gadolinium deposits are harmful to patients and continues to recommend the use of gadolinium-based contrast agents as appropriate.

Study: Newest drug-coated stents as effective as bypass surgery in coronary artery disease

The catheter-based insertion of one of the latest generation of drug-coated stents is just as effective as bypass surgery in treating coronary artery disease, according to a study in the latest issue of the New England Journal of Medicine. That was not the case with the prior generations of bare metal or first-generation drug-eluting stents.