News

Shockwave gets $40M to develop energy-delivering angioplasty balloon

Startup Shockwave Medical expects that its Lithoplasty balloon catheters will emerge as a pretreatment for calcified coronary lesions that's used instead of or prior to stenting. Now it's received $40 million to further advance toward that goal.

Edwards hits pause on Fortis mitral valve replacement trial due to safety concerns

Mitral valve replacement is intended to be the next big thing at Edwards Lifesciences, though it's still in the early research stage. But, for now, the company has paused a clinical trial due to safety concerns. Specifically, the company said it has "observed evidence of valve thrombosis" in a clinical trial of its Fortis transcatheter mitral valve replacement device.

Silk Road scores FDA approval for less invasive stent system

Silk Road Medical snagged FDA premarketing approval for its innovative transcarotid stent system, a big win for the company as it scores key regulatory signoffs for the device and forges ahead with product development.

NEA startup ClarVista gets $14.5M to gain CE mark for intraocular lens

Startup ClarVista Medical expects to use a newly gleaned $14.5 million financing to get a CE mark for its Harmoni modular intraocular lens system. The design of the cataract IOL is intended to make it easier for surgeons to correctly position the lens, as well as to make it simpler to exchange the optical component when required because of a dual-component structure.

U.K. team develops wearable graphene that's embedded in clothes

A professor at the University of Exeter has figured out how to embed flexible graphene electrodes into clothes. That could create applications for all sorts of new wearable devices, especially diagnostics.

U.K. diagnostic startup Abcodia gets $8M to launch early detection test for ovarian cancer

London-based Abcodia expects a U.S. and U.K. launch this year of its ovarian cancer screening test that's been found to be twice as effective as the testing that's currently standard. After releasing data on the ROCA test earlier this month, now it's raised £5.25 million ($8 million) to get through those goals.

FDA advisory committee says duodenoscope cleaning must be improved to provide assurance of safety

The FDA's advisory committee on gastroenterology devices unanimously concurred that duodenoscopes do not provide a "reasonable assurance of safety and efficacy," after anger over deaths and injuries from the infected devices boiled over earlier this year, following well-documented outbreaks of CRE bacteria in Seattle and Los Angeles.

Siemens launches hand-held, point-of-care coagulation analyzer to manage warfarin use

Siemens has launched its Xprecia Stride Coagulation Analyzer to enable rapid decision-making in physician offices and clinics regarding patient treatment with oral anticoagulation therapy warfarin. The vitamin K antagonist is routinely used to prevent clot formation caused by certain heart conditions, such as atrial fibrillation or heart attack, or during open-heart surgery.

Medtronic trumpets positive data for Tyrx antibacterial envelope in high-risk patients

Medtronic is touting positive study results for its antibacterial envelope in high-risk patients who undergo cardiac device implantation, a feather in the company's cap as it continues to forge ahead with the innovative technology.

Tech industry group IEEE releases software security guidelines for medical devices

IEEE has published guidelines for security in medical device software development and production. They are expected to serve as an early step toward establishing industry standards to secure medical devices systematically.

UPDATED: Apollo's minimally invasive intragastric weight-loss balloon shows promise in clinical trial

Apollo Endosurgery's intragastric balloon doubled weight loss compared to diet and exercise alone during its pivotal clinical trial, the company said during the Digestive Disease Week conference in Washington, DC.

Study: Pulmonary artery pressure monitoring aids heart failure patients, cuts costs

St. Jude Medical said in a new study that its CardioMEMS HF System can deliver improved outcomes and be cost-effective for heart failure patients who are already well-managed for their condition when they use pulmonary artery pressure monitoring.

Hospitals demo quick use of MRIs to gather critical info about stroke patients

MRI scans provide more information about stroke patients than CT scans but take longer to complete, raising a medical quandary. Two hospitals have demonstrated that by using streamlined procedures like simplified questionnaires, they can complete MRI scans within the recommended 60 minutes of arrival.

HeartWare hit with third Class 1 recall in little over a year

HeartWare has been hit by its third Class 1 recall since April 2014, all involving its flagship bridge to heart transplantation pump, the Ventricular Assist System.

Study: Remote monitoring of cardiac device patients results in better survival, less hospitalization

Tracking patients who have various cardiac devices via a remote monitoring system cuts down on hospitalizations and costs, while improving patient survival. That's according to a 5-year study by St. Jude Medical of more than 90,000 patients with pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization therapy devices.

Swedish asthma diagnostic company Aerocrine to be acquired by biotech Circassia for $214M

Clinical stage allergy player Circassia Pharmaceuticals, which had a huge $332 million IPO on the London Stock Exchange last year, will scoop up Swedish asthma company Aerocrine for SEK 1.78 billion ($214.3 million) after it got its latest asthma diagnostic device cleared by FDA in November.

Venter's HLI teams up with Cleveland Clinic for human genomics collaboration

J. Craig Venter's Human Longevity (HLI) is joining forces with Cleveland Clinic for a human genomics collaboration aimed at disease discovery, a little more than a year after the company kicked off operations with the promise of building the world's biggest human gene-sequencing platform.

Abbott's MitraClip can cut arrhythmias in half, according to data from Heart Rhythm conference

A study presented at the annual Heart Rhythm Society meeting in Boston found that Abbott's percutaneous MitraClip mitral valve repair device cut the number of ventricular tachyarrhythmia episodes in half following implantation in patients who had a prior cardiac rhythm device like a pacemaker or implantable cardioverter defibrillator.

Medtronic's leadless pacemaker and MRI-safe defibrillator present positive trial data at cardiology conference

Medtronic touted data on its investigational, MRI-safe implantable defibrillator and leadless pacemaker presented at the Heart Rhythm Society's annual meeting in Boston.

NEA takes the lead in Intact Vascular $39M Series B for PAD implant pivotal trial

Startup Intact Vascular expects the $38.9 million Series B it has raised will help it get its peripheral artery disease implant and delivery system into pivotal testing and through the FDA. It's been a long time since the company's $15.5 million first institutional round in September 2012.